Podcasts
ASCO in Action Podcasts
Retiring ASCO Chief Medical Officer Dr. Richard L Schilsky gives a far-reaching interview with ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis, who examines Dr. Schilsky’s trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. ASCO’s first-ever Chief Medical Officer even offers some friendly advice for Dr Julie Gralow, who starts as ASCO’s next CMO on February 15, 2021. In a touching tribute, Dr. Hudis also shares what Dr. Schilsky’s friendship and mentorship has meant to him personally, and suggests that Rich will still be supporting ASCO on critical priorities moving forward. Don’t miss this exchange with one of oncology’s greats!
Transcript
DISCLAIMER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
CLIFFORD HUDIS: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.
The ASCO in Action podcast is a series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO and the host of the ASCO in Action podcast series.
For today's podcast, I am especially pleased to have as my guest my friend, colleague, and mentor Dr. Richard Schilsky, ASCO's chief medical officer. Now, I am sure that many of our listeners have already heard that Dr. Schilsky will be leaving ASCO in February of 2021, retiring.
However, I want to reassure everybody that even in retirement, he will continue to make contributions and provide leadership to all of us. And his illustrious and path-blazing career in oncology spanning more than four decades is not quite over thankfully.
Rich is ASCO's first chief medical officer. And as such, he has made a truly indelible mark on all of us. He started with a proverbial blank piece of paper. The position had no precedent. It had no budget. It had no staff.
But now after just eight years in the role, he has helped make the CMO a critically important position at the society. And I have to say that success is more than anything due to Rich's vision and his leadership. And that's some of what we'll be talking about today.
So Rich, thank you very much for joining me today for what I hope is going to be a great casual but informative conversation about your amazing career, your unique role at ASCO, and maybe most importantly in the end what you see for the future of oncology not just in the United States, but around the world. Thanks for coming on, Rich.
RICHARD SCHILSKY: Thanks, Cliff. It's great to be here today.
CLIFFORD HUDIS: So with that, let's just dive right in and start at the very beginning. Rich, tell everybody why you decided to become an oncologist and maybe share a little bit about what those early days looked like for you and, in that context, what it was like to have cancer at the beginning of your career.
RICHARD SCHILSKY: Well, I knew from an early age that I wanted to be a doctor. And in fact, I had written a little essay when I was in sixth grade as a homework assignment called My Ambition. And my mother had tucked that away in a scrapbook. And I found it a number of years ago. And on rereading it, it was quite amazing to me to see what I was thinking about even then.
Because I said not only did I want to be a doctor, but I didn't think that was enough, that I wanted to be a medical researcher because I wanted to discover new information that would help people heal from whatever their diseases might be.
And so it was never really any doubt in my mind that I would be a physician. I went to medical school at the University of Chicago. But I was living in New York City at the time having grown up in Manhattan. And the only year we had off in medical school, the only time we had off in medical school, was the summer between the end of the first year and the beginning of the second year.
So during that time, I went back to Manhattan. And I was able to get a fellowship from the American College of Radiology that allowed me to essentially hang out in the radiation therapy department at New York University Medical Center, which was within walking distance of where I grew up. And so I would go over there every day. And I was taken under the wing of a young radiation oncologist.
And of course, I wasn't really qualified to do anything at that point except to follow him around, talk and listen to the patients. But that turned out to be a really formative experience for me because we saw the whole gamut of cancer. We saw head and neck cancers. We saw lung cancer. We saw patients with breast cancer and prostate cancer.
And in those years-- this is the early 1970s-- many of these patients have fairly locally far advanced disease and were quite debilitated by it. But listening to their stories, hearing about their hopes and their struggles, really demonstrated to me the human side of cancer.
So I went back to school and thought about this in the context of my own personal experience, which dated back to when I was in college when my mother's mother, my maternal grandmother, was diagnosed with breast cancer. This was 1968. And as you well know, there were very few therapies available for breast cancer in the late 1960s, mostly hormone therapies.
And my grandmother had the treatment that was considered standard of care at that time, which was extended radical mastectomy followed by chest wall radiation. And some years after that first mastectomy, she had a breast cancer that developed in the opposite breast and had a second extended radical mastectomy and chest wall radiation. And these were very traumatic and disfiguring procedures for her to go through.
Anyway, long story short is after another few years, she developed bone metastases and then brain metastases. And there was really very little that could be done for her other than hormone therapies. And having observed her go through that illness and realizing how limited our treatment options were and then having the experience after my first year in medical school pretty well cemented for me that I wanted to be an oncologist.
I thought actually about being a radiation oncologist. But then I did my internal medicine rotation in medical school, fell in love with internal medicine. And that sort of put me on the path to be a medical oncologist.
The clinical challenge of caring for cancer patients, the emotional attachment to those patients, and, of course, even then, the unfolding biology of cancer was so intellectually captivating that I actually applied for oncology fellowship when I was a senior medical student. So even before going off to do my medical residency, I had already been accepted as a clinical associate at the National Cancer Institute to start two years hence. And that's how I became an oncologist.
CLIFFORD HUDIS: So it's so interesting. Because, of course, the story I'm sure for many people interested not just in oncology, but even medical education, there are little things that don't happen nowadays that happened with you like that last little vignette about the early acceptance into an advanced training program before your fellowship among other things.
Can you remind us about the timeline? Because I think one of the things that many of our listeners often can lose sight of is just how new oncology really is as a specialty. ASCO itself founded in 1964. And the first medical oncology boards were mid-'70s, right? So you were in med school just before that second landmark, right?
RICHARD SCHILSKY: That's right. I graduated from medical school in 1975. I started my oncology fellowship in 1977. And I got board-certified in medical oncology and joined ASCO in 1980. And so that was the time frame at that point.
CLIFFORD HUDIS: So the internal medicine was actually, if I heard you right, just two years, not the now traditional four.
RICHARD SCHILSKY: Yeah. I was a short tracker. I did only two years of internal medicine training rather than three. I did my training at Parkland Hospital and University of Texas Southwestern in Dallas with at that time a legendary chair of medicine, Don Seldin, who I had to get permission from him to leave the program prior to completing the third year of residency because I had already been accepted into fellowship at NCI.
And he, Seldin, who was a brilliant chairman and a brilliant nephrologist, was not at all interested in cancer. And it took a bit of-- I was going to say arm twisting, but it really took bleeding on my part to get him to agree to allow me to leave the residency program to go to the NCI. But he eventually agreed.
And in those years, the first-year clinical fellowship at the NCI was like being an intern all over again. There were about 15 of us. We were on call overnight in the clinical center once every two weeks. We cared for all of our inpatients as well as had a cadre of outpatients.
We did all of our own procedures. We had no intensive care unit. So patients who were sick enough to require ventilator support, we cared on the floor in the inpatient service on our own with guidance from senior oncologists. It was a bit different from the way it is now. But, of course, it was fantastic on-the-job training because we just learned a ton and had to learn it very quickly.
CLIFFORD HUDIS: So that's actually a great segue to the advances because there was a lot to learn then. But, wow, there's a lot more to learn, I think, now. And I have real sympathy for trainees and younger oncologists for the breadth of what they need to learn. Again, just testing your memory, but platinum came along pretty much in the mid-'70s as well, right? That was a pivotal expansion of the armamentarium for us.
So what do you see-- when you summarize progress in cancer research and care over these decades, what do you think are the most pivotal or revolutionary milestones that you identify over the span of your career?
RICHARD SCHILSKY: Yeah. It's really interesting to think about it historically. There were the early years of discovery in oncology from the 1950s to the 1970s when we really had the introduction of the first chemotherapy drugs and the miraculous observation that people with advanced cancer could actually obtain a remission and, in some cases, a complete remission with chemotherapy and combination chemotherapy in particular.
And so that was the formative years of oncology as a medical specialty and really proof of concept that cancer could be controlled with drugs. When we got into the 1980s, the 1980s in many respects were the doldrums of progress in clinical oncology. There really was not a lot of innovation in the clinic.
But what was happening and what was invisible to many of us, of course, was that was the decade of discovery of the fundamental biology of cancer. That's when oncogenes were discovered, when tumor suppressor genes were discovered, when it became clear that cancer was really a genetic disease. And that is what transformed the field and put us on the path to targeted therapy and precision medicine as we think of it today.
So I think that clearly understanding the biology of cancer as we do now and all that it took to lead us to that point, which was a combination of understanding biology, developing appropriate technology that would, for example, enable the sequencing of the human genome and then the cancer genome.
And the other formative technology in my opinion that really changed the way we care for cancer patients was the introduction of CT scanning. When I was still a fellow at the NCI, we did not have a CT scanner. If we needed to get detailed imaging of a patient, we did tomography. And if you remember what tomograms looked like, they were really blurry images that you could get some depth perception about what was going on in the patient's chest or abdomen. But they really weren't very precise.
When CT scanning came along, it really revolutionized our ability to evaluate patients, assess the extent of disease, stage them in a much more precise way, which then allowed for better patient selection for curative surgery, better radiation therapy planning. So we don't often point to imaging advances as some of the transformative things that paved the way in oncology, but I think imaging is really overlooked to some extent.
So I think the technology advances, the biological advances, are the things that really allowed the field to move forward very quickly. And by the time we got into the mid-1990s, we were beginning to see the introduction of the targeted therapies that have now become commonplace today.
And then it was around 2000, I think, that we saw the introduction of Gleevec. And I'm reminded always about an editorial written by Dan Longo in The New England Journal a few years ago. And Dan and I were fellows together. We worked side by side on the wards at the clinical center and became very good friends.
And Dan in his role as a deputy editor of The New England Journal wrote an editorial a few years ago that was titled "Gleevec Changed Everything." And Gleevec did change everything. It changed our entire perception of what were the drivers of cancer and how we might be able to control cancer very effectively and potentially put it into long-term remission.
Now, of course, we know now that the whole Gleevec story is more of an exception than a rule in targeted therapy. And, of course, we know that tumors become resistant to targeted therapies. But we couldn't have known any of this back in the early years of oncology because we had no real insight into what caused cancer to grow or progress. And the notion of drug resistance, while we realized that it occurred, we had no idea what the mechanisms were. So it's such a different landscape now than what it used to be. It's quite remarkable.
CLIFFORD HUDIS: So as you tell the story, there's, of course, a lot of focus on technology, whether it's biology and understanding the key features of malignancy or imaging or more. But what I also note in your story and I want to come back to is the people. And I can't help but reflect on where we are in this moment of the COVID-19 pandemic. Yes, we've moved to telemedicine. Everything can be accomplished via technology. And, yet, the human touch is so important.
When we think about being in the room with people, when we think about face to face from the context of career development and your own career, you touched on Dr. Seldin, I think, already from the perspective of internal medicine training. But are there are other mentors or important shapers of your career that you think we should know about?
RICHARD SCHILSKY: Well, probably, the most influential person early in my career in medical school was John Altman. John, you may know, was the inaugural director of the University of Chicago's NCI-designated Cancer Center, which was one of the very first NCI-designated cancer centers in 1973 after the National Cancer Act of 1971 created the cancer centers program.
And John, who was a leading oncologist studying Hodgkin and non-Hodgkin's lymphoma, was a faculty member there. He was the director of our cancer center as I said. He took me under his wing even when I was in medical school and served as a real role model and mentor to me.
When I was in my internal medicine training as I mentioned earlier, Don Seldin, the chair of medicine, was never particularly interested in oncology. So, to some extent, I didn't have-- I had great internal medicine training. But I did not have good mentorship in oncology. When I got to the NCI, then my whole world really opened up.
And the two pivotal people there in my career were Bob Young, who was chief of the medicine branch and was my clinical mentor and remains a mentor and friend to this day, and then, of course, Bruce Chabner, who was the chief of the clinical pharmacology branch.
And in my second year of fellowship when we all went into the laboratory, I went into Bruce's lab. And that's where I really got interested in the mechanism of action of anti-cancer drugs and ultimately in drug development and early phase clinical trials. And both Bob and Bruce remain very close to me even today.
CLIFFORD HUDIS: So I'm concerned about time on our call today on our discussion. Because we could obviously fill lots of hours on all of these remarkable experiences and amazing people you worked with. But I'm going to ask that we fast forward a little bit.
You and I share, I think, passion and love for ASCO. So I think that it's reasonable for us to focus a little bit on that for the time we have left here. You didn't start out obviously as chief medical officer at ASCO. But you were a really active ASCO volunteer and leader. Maybe tell us a little bit about some of the ASCO volunteer roles that you engaged in and what that meant to you at the time and how that led to this role.
RICHARD SCHILSKY: Well, I'll be brief. I joined ASCO in 1980 at the first moment that I was eligible to join ASCO. I had attended my first ASCO meeting the year before, 1979, when I was still in my fellowship training. And it was clear to me even then when the whole annual meeting was about 2,500 people in two ballrooms in a hotel in New Orleans that that was a community of scholars and physicians that I wanted to be a part of.
And so, over the years, I did what people do even today. I volunteered to participate in whatever ASCO activity I could get involved with. Over the years-- I think I counted it up not too long ago-- I think I served or chaired 10 different ASCO committees, more often serving as a member, but in a number of those committees also serving as the chair over many years.
And as I became more deeply involved in ASCO and saw other opportunities to engage, I had the opportunity to run for election to the board and was-- after a couple of tries was elected to serve on the board and then eventually elected to serve as ASCO president in 2008-2009.
But the attraction of ASCO in many ways was a community of diverse but, in many ways, like-minded people, people who had similar passion and drive and focus. But I think what you get at ASCO in many ways is the wonderful diversity of our field. If you work in a single institution for much of your career as I did and as you did, you get to know that institution pretty well. You get to know its perspectives and its biases and its strengths and its weaknesses.
But there's a whole world of oncology out there. And you can get exposed to that at ASCO because you meet and work with colleagues from every clinical setting, every research setting, people who have remarkable skills and interests and passions. And it's just a wonderful environment to help develop your career. So I consider myself to be extremely fortunate to have had the journey in ASCO that I've had culminating, of course, with ultimately my coming on the staff as ASCO's first chief medical officer.
CLIFFORD HUDIS: We often joke about that blank sheet of paper. But in retrospect, it's very obvious that you had built up that collection of LEGO blocks, and then you assembled them all into the ASCO Research Enterprise, a name you gave it.
And it really, in retrospect, builds, I think, very cleanly upon all of your prior experience, but also the vision that you developed based on that experience for how research should be conducted. Can you maybe share with everybody the scope and vision for the ASCO Research Enterprise, what the intent was, and where you see it going, and what it includes today?
RICHARD SCHILSKY: Sure. I won't claim that I came to ASCO with the whole thing fully developed in my mind. As you said, when I came, I literally did have a blank slate. Allen Lichter, who hired me, said, come on board and help me make ASCO better. And so I, in a sense, reverted to what I knew best how to do, which was clinical research.
And having in my career been a cancer center director, a hem-onc division chief, a cooperative group chair, I had a lot of experience to draw on. And it was obvious to me that ASCO was fundamentally an organization that took in information from various sources, evaluated it, vetted it, collated it, and then disseminated it through our various channels, most notably our meetings and our journals.
But ASCO itself did not contribute to the research enterprise. And that seemed to me to be a lost opportunity. We knew that ASCO had lots of data assets that could be of interest to our members and to the broader cancer community. But they were scattered all around the organization and not particularly well annotated or organized. So we began to collate those. And they are now available to ASCO members on the ASCO data library.
I recognized that we did not have an organized unit in ASCO to support or facilitate or conduct research. So, in 2017, we formed the Center for Research and Analytics and brought together staff who were already working at ASCO but scattered in different departments but all people who had an interest in clinical research or research policy and brought them into this new unit, which has really become the focal point for research work at ASCO.
We recognized that ASCO members for many years were interested in surveying their colleagues, surveying other ASCO members, to help advance research questions. But ASCO actually had a policy that prohibited that.
So that never really made good sense to me. It seemed like a lost opportunity. And we were able to create a program and have the ASCO board approve it whereby any ASCO member could opt in to participate in what we now call the Research Survey Pool.
And in doing so, they are essentially agreeing to participate in research surveys conducted by their colleagues. So that program is now up and running. There are, I think, eight surveys that have been completed or are currently in the field. And this is now a service that ASCO provides through CENTRA to its members to enable them to survey their colleagues for research purposes.
Most importantly, I think we saw an opportunity back in 2014 or 2015 to begin to learn from what our colleagues were doing in clinical practice as they began to deploy precision medicine. And there was a lot of genomic profiling that was going on at that time. It was revealing actionable alterations in roughly 30% or so of the tumors that were profiled.
But there was a lot of difficulty in doctors and patients obtaining the drugs that were thought to be appropriate to treat the cancer at that particular time because most of those drugs would have to be prescribed off label. And there was not a sufficient evidence base to get them reimbursed. And, moreover, even if they could be reimbursed, there was no organized way to collect the patient outcomes and learn from their experiences.
So that led to us developing ASCO's first prospective clinical trial, TAPUR, which really solves both of those problems. Through the participation of the eight pharmaceutical companies that are engaged with us in the study, we are providing-- at one point, it was up to 19 different treatments free of charge to patients.
These are all marketed drugs but used outside of their FDA-approved indications. And we were collecting data on the patients, the genomic profile of cancer, the treatment they received, and their outcomes in a highly organized way.
And so now this is a study that we launched in 2016. We're now almost to 2021. We have more than 3,000 patients who have been registered on the study, meaning consented to participate, more than 2,000 who have been treated on the study. And we are churning out results as quickly as we can about which drugs are used or not useful in the off-label setting for patients whose tumors have a specific genomic profile.
So we built all this infrastructure. And having this in place has also then allowed us to respond rapidly to unmet needs. So when the COVID-19 pandemic overwhelmed all of us, and when our members were looking for information about what was the impact of COVID-19 on their patients, one of the things we were able to do because we had CENTRA, because we had a skilled staff and an infrastructure, was to very quickly stand up the ASCO COVID-19 registry, which we launched in April of this year.
And there are now about 1,000 patients who've enrolled in the registry from around 60 practices that are participating. And we will follow these patients now longitudinally and learn from their experiences what has been the impact of the COVID-19 illness on them and their outcomes, how has it disrupted their cancer care, and ultimately how that impacts their overall cancer treatment outcomes.
So as I now contemplate leaving ASCO after eight years having started with a blank slate, I'm very proud of the fact that I think I'm leaving us with a remarkable infrastructure. We now have a clinical trials network of 124 sites around the country participating in TAPUR that we never had before. We have through the work of CancerLinQ a real-world evidence data generator that is beginning to churn out valuable insights.
We have a capacity to survey ASCO members for research purposes. We have an ability to stand up prospective observational registries to gather information longitudinally about patients and their outcomes. We have a core facility in CENTRA with highly skilled data analysts and statisticians that can support these various research activities.
So ASCO is now primed, I think, to really contribute in a very meaningful way to the gaps in knowledge that will forever exist in oncology just because of the complexity of all the diseases we call cancer. And that's what I mean by the ASCO Research Enterprise. It is in fact remarkable and, I think, powerful enterprise if we continue to use it effectively.
CLIFFORD HUDIS: Well, that's an interesting segue to my next thought, which is really about what comes next. I'll talk about you. But let's start with ASCO first. Your successor, Dr. Julie Gralow, obviously has been announced publicly. She's an accomplished clinician and researcher. She has a known recognized passion for patients, patient advocacy, clinical research through her leadership at SWOG but also health care equity and global oncology.
So from your perspective, having created all of these assets and resources, what advice would you give Dr. Gralow publicly on how to make the position hers, what to take us to next? And I do want to acknowledge for everybody listening that the hints I've been making up until now are that Rich has agreed that he will continue to contribute as a leader to TAPUR for the short term, at least, at least the next year helping Julie get fully oriented to this program and others. So what will your advice be to Julie?
RICHARD SCHILSKY: That's a great question. She's a great selection. And congratulations on hiring her. I think there are two key issues, I think, maybe three. One is to have a broad scope and cast a wide net. Oncology care and cancer research and cancer biology are incredibly complicated and nuanced and broad in scope.
And although Julie is an accomplished breast cancer clinician and researcher, in this role at ASCO, you have to be very broad. You have to understand all of cancer care, all of cancer research, all of policy and advocacy not as an expert in necessarily in any one aspect of ASCO's work, but you have to understand the impact of all of those things on cancer care providers and on cancer patients.
And it's important to always be looking to the future. The future is going to be here before you know it. And we as a professional society have to prepare our members for that future. So that leads me to the second point, which is listen to the members.
The members are the people on the front lines who are delivering care to patients every day. And, fundamentally, ASCO's job is to be sure that our members have all the tools and knowledge and resources that they need to deliver the highest quality care to patients every day. So listening to what they need, what their struggles are, what their burdens are, is extremely important.
And then the third thing I would recommend to her is that she get to know the staff and colleagues that she'll be working with. ASCO has a remarkably accomplished, skilled, motivated, passionate staff, many of whom have been with the organization for years, if not decades, who understand what ASCO can and cannot do and who understand what our members need. And she will be well advised to spend a good portion of her first few months on the job just listening and learning from her colleagues.
CLIFFORD HUDIS: That's always good advice for anybody making a big career move. But, of course, the wisdom you bring to it is palpable and much appreciated. And I'm sure Julie will be taking your advice. And, by the way, so will I continue to do that even after you make your move. So speaking of your retirement, can you share with us a little bit about what it's actually going to look like for you? Is it about family? Or are you still going to have some professional engagement? Again, I suggest that there might be some already, but maybe you could expand on it.
RICHARD SCHILSKY: Yeah. I'm still fully focused on my work at ASCO. And, of course, as you know, when I wake up on February 15, I will no longer be ASCO's chief medical officer. And it's going to be a bit of a rude awakening. Fortunately, I will be able to continue my engagement with ASCO through the TAPUR study as you mentioned. I will, of course, forever be at ASCO member and a donor to Conquer Cancer and be willing to serve the society in any way.
I have a number of activities that I've been involved with even throughout my time at ASCO. Not-for-profit boards, for example-- I'm on the board of directors of Friends of Cancer Research. I'm on the board of directors for the Reagan-Udall Foundation for FDA.
I plan to continue with those activities as long as they'll have me. I've been serving the last few years on the board also of the EORTC, the large European cooperative clinical research group. And I expect to continue in that role.
Beyond that, I will see what opportunities come my way. I think one of the things about retirement if you will that I'm looking forward to is the opportunity to pick and choose what to work on based on what interests me without having the burdens of having a full-time job.
On the personal front, of course, we're all looking forward to crawling out from the pandemic. I've basically been locked in my home outside Chicago since March. And I'm looking forward to getting back out to a little bit of a social life. As you know, I have two grown daughters and now three grandchildren, two of whom are in Atlanta, one of whom is near by us in the Chicago area. So looking forward to spending time with them as well.
So it will be a change for me to be sure after working as hard as-- I feel like I've worked for really now 45 years since I graduated from medical school. But I also feel like I'm not quite done yet and that I still have ways in which I can contribute. I just feel like at this point, maybe it's time for me to choose how I want to make those contributions and spend a little bit more time doing some other things.
CLIFFORD HUDIS: Well, both you and my predecessor, Allen Lichter, are modeling something, have modeled something, that I think is not often discussed but can be very important. For people and for institutions, change is not a bad thing. And setting the expectation that you will pour your heart and soul into something but not necessarily do it alone or forever and not prevent others from taking that role at some point, that's a really-- I think it's a selfless kind of sacrifice in a way.
Because, of course, you could stay and do what you're doing for longer. But as you and I have discussed, there is a value for all of us collectively in having fresh eyes and new people take organizations in a new direction. That's how I ended up here frankly. And I think that's the kind of opportunity you're creating right now, something that should be celebrated in my opinion.
RICHARD SCHILSKY: Well, thanks. And I couldn't agree more. When I look back at the arc of my career and having all the different kinds of leadership roles that I've had, I basically have made a job change every 8 to 10 years. I was the director of our cancer center for nearly 10 years. I was associate dean for clinical research at the University of Chicago for eight years, another position that I created from a blank slate at that institution.
The exception was serving 15 years as a CALGB group chair. But that was a position I really loved and enjoyed and felt like at the end of the first 10 I hadn't quite accomplished everything I wanted to accomplish.
But the point is that I think it is both necessary for organizations to have regular leadership change. And it's also refreshing for us as individuals. There gets to a point where you feel like you can do your job in your sleep. And I actually think that's a good time to make a change.
Because if that's the way you feel, you're not being sufficiently challenged. And you're probably not being sufficiently creative. And so it's a good time to move on and refresh your own activities and give your organization a chance to bring in someone to hopefully build on whatever you've created and bring it to the next level.
CLIFFORD HUDIS: Well, I agree with all that, although I think your comment there about doing the job in your sleep would not apply because I'm pretty confident that the environment and opportunities have continued to evolve in a way that has made it interesting from beginning to end. But you don't have to rebut me on that. I just want to thank you very, very much, Rich.
As we set up this podcast, I expected that we would have a really fun and enlightening conversation. And, of course, you did not disappoint. We could talk for much, much longer if we only had the time.
On a personal note to you and for the benefit of our listeners, I want to share that Rich has been for me a remarkable friend and mentor and colleague. I first met Rich at the very beginning of my career when my mentor, Larry Norton, pushed me out from Memorial into the larger world. And he did that first and primarily through ASCO and the Cancer and Leukemia Group. Those are really the two places where I was exposed to the world.
And through the CALGB, Rich really began to offer me and others, many others, opportunities that shaped careers plural, mine and others. So when I got to ASCO as CEO, Rich was there. And I knew I could always depend on you to be clearheaded, intellectually precise, constructive, visionary. And the thing about you, Rich, is that you never would say yes to anything unless you knew for sure you could do it and indeed, I think, how you could do it.
I always share this story which your staff at CENTRA pointed out to me. And I have to admit that I hadn't picked it up myself. But in all the years of now working down the hall from Rich, probably hundreds and hundreds of hours of meetings, he never has taken a note in front of me. And, yet, everything we talk about, every action item we conclude to pursue, they all get done.
So I don't know, Rich. You have a remarkable way of organizing your thoughts and your plans, keeping it together, and getting things done. And I'm going to miss that tremendously in the years ahead.
So, Rich, I want to say congratulations. Congratulations on reaching this really important milestone in your life. Thank you on behalf of ASCO and the broader oncology community and the patients we care for and their families for making the world a better place. And just as a small thing, thank you for joining me today for this ASCO in Action podcast.
RICHARD SCHILSKY: Thank you, Cliff. It's been great.
CLIFFORD HUDIS: And, for all of you, if you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And, while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.
In the latest ASCO in Action podcast, ASCO CEO Dr. Clifford A. Hudis shares a quick preview of what's to come for the 2020 ASCO Advocacy Summit and Week of Action, which will take place September 14-18.
Typically, ASCO volunteers from across the country gather in Washington, D.C. to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research through in-person meetings with their Members of Congress. Due to the COVID-19 pandemic, the 2020 ASCO Advocacy Summit will be a virtual event, but participants can expect the same important advocacy and education opportunities that the event provides every year. All ASCO members are encouraged to participate in the Congressional Week of Action by signing up with the ACT Network (through the Advocacy Center on ASCO.org).
Subscribe to the ASCO in Action podcast through iTunes and Google Play.
Transcript
Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at “Podcast dot ASCO dot org” (podcast.asco.org)
The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer.
I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to share with listeners a preview of the 2020 ASCO Advocacy Summit and Week of Action taking place September 14-18.
Typically, ASCO gathers volunteer advocates in Washington, D.C., in September for education sessions and in-person meetings with their Members of Congress.
Due to the COVID-19 pandemic—like so many events scheduled to take place this year—the 2020 ASCO Advocacy Summit will be a virtual event, but that said, participants can expect the same advocacy and education opportunities that the event provides every year.
ASCO volunteers will meet with Members of Congress and their staff by phone or video to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research.
Advocacy Summit attendees will also attend webinars to receive education and training on lobbying Congress and the current political landscape.
What is different this year is our online Week of Action, which will give all ASCO members an opportunity to advocate on critical issues of great importance to the cancer care delivery system in the United States.
Participants in the Week of Action will amplify the Advocacy Summit’s messages through email and social media messages to Members of Congress using ASCO’s ACT Network. And, it’s easy to get involved and make your voice heard. You just need to click on the link to the ACT Network in the Advocacy Center on ASCO.org and sign up to receive ASCO ACT Network emails. Then, you’ll get all the information on the fastest and easiest ways to contact lawmakers delivered directly to your inbox. We hope you will participate as much as you can—the effort will take just minutes. Even one message a day by every ASCO member to your representatives in Congress will have a tremendous impact.
During the virtual Advocacy Summit, which will be held in the middle of the Week of Action on September 16, ASCO volunteer advocates will have their virtual meetings with Members of Congress and their staff. The three issues or “legislative asks” that they will be discussing will be the same asks that ASCO members will contact their Members of Congress about during the Week of Action.
One, we will ask Congress to support legislation—The CLINICAL TREATMENT Act, which will give all Medicaid beneficiaries coverage of routine costs when enrolled in clinical trials—coverage Medicare and private insurance plans already provide. The importance of improving health equity has become even more apparent during the COVID-19 pandemic, and this legislation takes us one step closer to that goal.
Two, ASCO volunteer advocates will request lawmakers to co-sponsor the Safe Step Act, which will help protect patients from harmful step therapy protocols, which ASCO believes is never appropriate in the treatment of cancer.
And three, we’ll address the impact COVID-19 has had on cancer practices and research. Specifically, advocates will ask Congress to endorse maintaining reimbursement flexibilities for telehealth, as many oncology practices have rapidly transitioned to telehealth to ensure patients continued receiving treatment during the pandemic. We’ll also be asking Congress to provide emergency funding to the National Institutes of Health to mitigate disruptions caused to labs and clinical trials by COVID-19, and to restart research across the county.
These are the same issues that participants in the Week of Action will be advocating for all week long in their outreach to Congress.
The goals of the Advocacy Summit and Week of Action are to advance priority legislation, amplify the collective voice of the cancer care community on Capitol Hill, and to get ASCO members involved in advocacy initiatives.
Members of Congress and their staff have grown accustomed to virtual constituent meetings, and personal stories continue to be the most effective form of advocacy, so the Advocacy Summit and Week of Action—even virtually—remain critical to ASCO’s larger advocacy efforts.
In addition to the meetings and messages between advocates and lawmakers, the ASCO Advocate of the Year and the Congressional Champion for Cancer Care will be named during the Advocacy Summit.
In closing today, I encourage everyone listening today to follow the Advocacy Summit through social media by way of the hashtag ASCO Advocacy Summit (#ASCOAdvocacySummit) on Twitter AND to participate in the Week of Action through the ACT Network.
A link to the ACT Network and all the information you’ll need to participate in the Week of Action is available at ASCO dot org slash ASCO Action (www.asco.org/ascoaction).
Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode.
The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at “Podcast dot ASCO dot org” (podcast.asco.org).
ASCO President Lori J. Pierce, MD, FASTRO, FASCO, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to discuss how her childhood inspired her to become an oncologist and how the theme of her presidential year, “Equity: Every Patient. Every Day. Everywhere.” is more important than ever as the country responds to a healthcare pandemic that is disproportionately impacting people of color.
“Every patient, no matter who they are, deserves high-quality care and every patient has the right to equitable care,” says Dr. Pierce. “We have to get to the root causes to understand the barriers that patients face if we’re going to really make a difference, so it’s important to me that equity be front and center of everything that we do."
Subscribe to the ASCO in Action podcast through iTunes and Google Play.
Transcript
Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.
The ASCO in Action Podcast is ASCO's series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.
Today I'm really pleased to be joined by Dr. Lori J. Pierce, ASCO's president for the 2020-2021 academic year. Dr. Pierce is a practicing radiation oncologist. She is a professor and vice provost for academic and faculty affairs at the University of Michigan. And she is the director of the Michigan Radiation Oncology Quality Consortium.
Dr. Pierce, thank you so much for joining me for this podcast. My hope today is that our conversation will give our listeners a better idea of who you are, what and who has had important impact and influence over your life, and what your professional career and path as a radiation oncologist has looked like. I also hope to highlight what you hope to accomplish during your presidential year.
Dr. Lori Pierce: Thank you, Dr. Hudis. I'm glad to join you today. Before we get started, I just want to note that I have no relevant financial relationships to disclose.
Dr. Clifford Hudis: Now before we start to discuss the details of your presidential theme and your current role at ASCO, I think our listeners will be really interested to learn how your childhood inspired you to become a radiation oncologist. And I hasten to add ASCO staff were really excited by the stories that you shared when you gave an all staff presentation a few weeks back. So, can you talk a little bit about your childhood summers in North Carolina, how they were informative for you, and how they inspired your career?
Dr. Lori Pierce: Sure. I'm happy to. So first of all, I'm originally from Washington D.C. But my father's family, which is quite large, is from a small town in North Carolina called Ahoskie. And that's in the north eastern part of the state, maybe about 30 minutes just beyond Virginia. And I have tons of relatives. I used to love to go visit them every summer because I would get spoiled.
But that was in the south in the '60s. And in retrospect there was significant segregation there. And I again would have a great time going to visit my family. But I noticed--and it was something you noticed and you put in the back of your head--that when there were health care issues, there was one doc that my family could use. And he was great. Doc Weaver, he did it all.
He was the one who would come to the homes, deliver babies, take care of all the medical issues--he did at all. And so, people just revered him because he always seemed to help people. And that stuck in my mind. That was actually when the first times that I thought about possibly becoming a physician because he always seemed to make people better.
But then also the experience as I got older made me acutely aware that there was indeed segregation in Ahoskie and that there was inequity in care. Even Doc Weaver seemed to be a great doctor for someone--I was 5 or 6 at the time. And to my eyes, he was great. Clearly there weren't choices in terms of care. And that was my first exposure to inequity in terms of health care.
Dr. Clifford Hudis: Well that's interesting, of course. And obviously we're going to circle back to this. But before we get to that, one of the things that I always point out to Nancy Daly--who's the CEO of Conquer Cancer--is that all roads lead through Philadelphia in medicine. You proved that true, right?
Dr. Lori Pierce: Yes. So, I went to the University of Pennsylvania. I got my degree in engineering. I should say at that time I clearly was planning to go into medicine. But I was going to go into radiology. And so biomedical engineering was a great area to pursue. I majored in biomedical engineering and minored in chemical engineering from the University of Pennsylvania.
And so, then I applied to Duke for medical school. I was accepted. But I decided to defer my admission. And so, I worked for a while before going into medicine.
Dr. Clifford Hudis: Well that's interesting. And when you deferred your admission, was this because you had something you wanted to do, or you needed to essentially to save money in order to go to medical school? What did you do in that break?
Dr. Lori Pierce: Yeah. So, it was very much the latter. My parents were absolutely wonderful people. And they focused very much on education from my sister and me--for us to go to the best possible colleges. My parents never had an opportunity to go to college. And so, they very much wanted the best colleges for my sister, Karen, and I.
But we had a ground rule in our family. And that was that if my sister or I decided to go and pursue education beyond undergraduate degree that we would need to pay for that. And so, I knew that. And even though I was very fortunate to get quite a bit of scholarship from Duke, there was still going to be a lot that I was going to have to pay.
And so, I made a decision, instead of taking out a lot of loans, that I was actually going to work. At that time--probably now as well--being an engineer brought a very good salary. And so, I elected to defer my admission for medical school and take the offer that gave me the most money.
And that ended up being a job in Round Rock, Texas, which is just outside of Austin. And I have to tell you this was back in 1980. And it's not at all what Round Rock is like now. I hear Round Rock--since industry is there now--is really just a suburb of Austin. But at that time, Round Rock was a sleepy town I-35 from Austin. So, I can live in Austin and work in Round Rock.
And it was a very interesting experience. I worked for McNeil Consumer Products. I was the second shift supervisor. And it was an interesting time because here I was fresh out of undergrad, green behind the ears, and an African-American woman, as a supervisor to people who were generally in their 40s through 60s, most of whom had never been out of the state of Texas, and you look at that and you say, oh my gosh. How did I get here? Why am I here? Why did I decide to do this?
And you think about how different people are. But when you start to work with people, you realize that there are common threads. And you find those common denominators. And you learn that even though we may look different on the outside, there are a lot of things that are similar in the inside.
And I think the lessons that I learned as that second shift supervisor have served me well in medicine because you can always find a common denominator with patients, even when apparently at first look, it looks like you're very, very different. So, they were very good lessons I think that I learned that I wouldn't have done had I not chosen that path.
Dr. Clifford Hudis: So, I think that some of what you learned will no doubt pop up as we talk in greater detail now about your presidential theme. Let me just start by saying for me personally, this is one of the highlights of the year for me each year, when our president comes on board in a sense and begins to present their vision for their theme and what they hope to see us achieve over the year they serve as president.
And it's amazing because of course the wide range of background experiences as well as aspirations that different people bring. And you certainly I think came into this with a very clear vision of equity for every patient every day everywhere. Can you expand I think--I wouldn't say speak on this because you've already begun to touch on it--but can you expand on what you were hoping to see accomplished through this theme and what motivated you to focus on it specifically in your role as ASCO president?
Dr. Lori Pierce: A multitude of things. It's hard to really pick out one. But certainly, I think we all are acutely aware of the different outcomes for people of color. In terms of almost any industry you look at, the outcomes are less favorable, significantly so for people of color. And you look at those numbers and you know that there are reasons to explain this.
And it's not just biology, which is what a lot of people propose. And quite often it's not biology at all, that clearly these patients are lower socioeconomic status. The majority of these patients are poor. Late diagnoses, inability to receive treatment, transportation issues--there's a whole myriad of reasons why the outcomes are different. And you look at that, and you say, every patient no matter who they are, deserves high quality care. And every patient has the right to equitable care.
And we have to get to the root causes to understand the barriers that patients face if we're going to really make a difference. And so, it's important to me that equity be front and center in everything we do. And ASCO again has done so much. That's at the heart of ASCO, of making sure the message is there that every patient deserves high quality care.
But I wanted to actually make equity our theme. Equity has actually never been the theme at ASCO. So, I want to actually call it out and make it our theme for the year.
Dr. Clifford Hudis: Well the timing of course in many ways is really quite remarkable. I know a lot of people would use the word fortuitous. And the truth is that just means in a sense coincidental. But that's what it was.
In early 2020 certainly nobody could have anticipated that we would be facing, nationally and globally, a pandemic that would so disproportionately impact people of color or that there would be a tipping point through yet another brutal crime against a black American and that this would so completely capture the nation's attention. And I have to say broad support. Can you speak a little bit more therefore about the timing of these events and your theme and why this is so important for us to act at this point?
Dr. Lori Pierce: I think you summed it up actually very nicely. Again, the theme was chosen before the pandemic. It was just the theme that I felt was the appropriate theme at this point in ASCO. And then the pandemic happened. And we saw how it disproportionately affected those who had comorbidities, those who were the essential workers, so those people who didn't have the luxury to work from home. Often the people who had a lot of comorbidities and the ones who were most at risk for contracting the virus and subsequently dying from the virus.
And I actually take a little bit of pride in that I'm from the state of Michigan. And Michigan was actually one of the first states that started reporting the COVID data by race and ethnicity. So, it was actually one of the first states that made the observation that there were cohorts of patients that had a significantly worse outcome. And so, the country--the world learned that people of color did more poorly with COVID.
It's not enough to say, OK, these people do poorly with this. We then have to dissect the reasons why and provide explanations, so we get to the root of the problem. So that's COVID. And then we saw that more of the senseless deaths that we've seen in the past, but we've seen even more of as of late.
And maybe that's because we now have cell phones. And we see things a lot more--things that have probably been going on for quite a while. We know that these have been going on, but maybe not to the degree that we know now. And we have to acknowledge there's structural racism. And so, once we acknowledge that, then the next thing is we have to initiate steps that eradicate it. And we have to initiate mandatory steps to eradicate it.
So, then you come back to the theme--equity, every patient, every day, everywhere. And I should have said in everything that we do. We see these horrors playing out. And we can look at that and say--maybe not the pandemic, but the senseless murders--we've been here before. We've been here with the protests. We've seen all that before. And nothing has changed.
I am cautiously optimistic that this time is different, that the world is in a different place. And this is no longer acceptable. And people are not going to look away, that they are going to stare this down. And they are going to create change.
And so, I am I'm optimistic that this will not just be another set of deaths of poor people at the hands of police, that the world is awake now, and change will come. And so, the theme of equity is perhaps more impactful now than it ever would have been in the past.
Dr. Clifford Hudis: I'm going to just switch gears here a little bit, and speaking from personal experience, both warn you and challenge you that the year as ASCO president goes really quickly. And given that and given the lofty ambition, is there any way that you would be able to commit to what you actually want to see get done? What box can we actually check off during this term?
Dr. Lori Pierce: I like the way you phrased that. I think back--there was an interview that I did when I was President-elect--and someone said what do I want my legacy to be? And I pushed back on that because you can't create a legacy in a year. It goes by very, very quickly. And so, I think the question is, what do you think you can realistically accomplish in a year?
And the answer that I gave to them is going to be similar to the answer that I give to you. And that is you want to use your time and take a great organization like ASCO and perhaps make it even greater. And I think that is a very real goal here because again, I am building on a strong foundation of a lot of what ASCO already has in place.
Equity is at the heart of everything ASCO does. You know this. You're the CEO. You know this. And so ASCO has stood up so many programs in their various divisions that relate and are based on equity of care. But ASCO by being large and being complicated can have some of these programs in silos. And if I can help to connect the dots, if you will, and make it almost a seamless presentation of equity, that will be a major strength.
For example, one of the things that I want to do--and people have told me I will not be successful--others have tried and were not successful--and that was to embed equity in our annual meeting. As you know what we've typically done is have sessions that are dedicated for equity, which is great. And they've been fabulous sessions and wonderful speakers.
The problem is a lot of our members have not taken advantage of those opportunities. And it's not because people don't want to know about equity. I'm sure it's just they're trying to fit so much in a short amount of time because there's so much going on at the same time at ASCO, trying to learn all the latest therapies. And they just don't have time for the equity sessions.
So, I get that. So, a strategy would be to embed equity in the sessions. And again, I've been told that this has been tried before and has failed. That doesn't deter me. That doesn't dissuade me from moving forward with this and being optimistic that it will succeed this time, again, because we're in a different time now. I think the world has awakened. And equity is very important. So, it is very high up on people's checklist when they go to ASCO.
And then second, I'm the president of ASCO. So, I hope to use both of those to gently push this idea so that we really can capture more of equity in all of the sessions, or the appropriate sessions at the annual meeting.
Dr. Clifford Hudis: Well I've got to say--speaking of connecting the dots, which was the image you used--there is one I think area of progress that's already taking shape. And that's this exciting new collaboration between ASCO and the Association of Community Cancer Centers, or ACCC. This is focusing on increasing participation of both racial and ethnic minority populations in cancer research, which to your point, is something that we have been focusing on for years. But we really need somebody to move the needle. Can you talk a little bit about this initiative and what you hope to see formed and accomplished through this?
Dr. Lori Pierce: Sure. So, I am very happy--actually, largely thanks to you for putting Randy Oyer, who is the president of ACCC, and I in contact with one another--to set up this collaboration. So, we all know that if you look at people of color--let's say African Americans and Hispanics--and look at their participation in clinical trials, it is much lower than their representation as cancer patients. If you look at most the numbers, maybe it's around 3% to 5% of patients in the clinical trials are Hispanic or African American, whereas those two groups make up about roughly 15% of patients with cancer. So, there's clearly a disconnect in the representation of those ethnicities and races in our clinical trials.
And so many have tried to come up with strategies to improve the enrollment. And we are working together--ACCC and ASCO--we're putting together a very robust steering committee of individuals who have thought long and hard about accrual of minorities under clinical trials. And we are sending out an RFI to request ideas from people in ASCO and ACCC who also have been thinking long and hard about this issue for their strategies--their suggestions for strategies for how we can improve accrual.
And then the steering committee will review what we take in as well as our own thoughts and then try one or two of these strategies within TAPUR. As you know TAPUR is the trial with an ASCO. TAPUR is completely run by ASCO. So, we have the flexibility to be able to try out new things. It's almost like a laboratory, if you will, for new ideas.
And if we see that there are one or two strategies that do seem to be successful in terms of increasing the uptake of minorities, these will be strategies that we can suggest to some of the cooperative groups to employ in their trial. So, it's an exciting time to use TAPUR as a laboratory to try out new strategies. And I am very grateful for the opportunity to be able to work with Randy and all of the infrastructure that ASCO has to make this a reality. So, we're working on that.
Dr. Clifford Hudis: Well that's great. This is not to put you on the spot. And there may not be any more. But is there anything else that you want to make sure ASCO members hear or take away from this conversation? What's the one message that you think that they should receive from our conversation?
Dr. Lori Pierce: I guess we're all in this together. The beauty of ASCO is from member engagement. We just have fabulous members in terms of their motivation to make lives better for our patients. And so, I guess I would ask if there are any additional ideas that our members have that will help us move the needle even more and even more quickly, please reach out to me.
I would love to hear people's thoughts. We're always open for new concepts. And it takes a village. And I just would hope people would feel comfortable providing ideas for us to go forward.
Dr. Clifford Hudis: Well that's great. Thank you, Dr. Pierce, for taking the time to speak with me today. I'm really grateful to you for this. And I'm excited as well for the year ahead, both for you and for all of us at ASCO.
Dr. Lori Pierce: Thank you so much.
Dr. Clifford Hudis: I want to remind listeners that you can visit asco.org to learn more about the ASCO ACCC initiative. And even better that's where you can submit ideas that will help address the issues related to longstanding barriers to diversity in cancer clinical trials. We want to hear from you.
Until next time, thank you for listening to this ASCO in Action podcast. And if you enjoyed what you heard today, please don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.
The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org.
ASCO Special Report: Resuming Cancer Care Delivery During COVID-19 Pandemic
American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Piyush Srivastava, the past chair of ASCO’s Clinical Practice Committee, in the newest ASCO in Action Podcast to discuss the recently released ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic. Dr. Srivastava was instrumental in developing the report, which provides detailed guidance to oncology practices on the immediate and short-term steps that should be taken to protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis.
Subscribe to the ASCO in Action podcast through iTunes and Google Play.
Transcript
Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.
This ASCO in Action podcast is ASCO's series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.
I'm Dr. Clifford Hudis, CEO of ASCO. And I'm the host of the ASCO in Action podcast series. I'm really pleased to be joined today by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee. Dr. Srivastava is also a practicing gastrointestinal oncologist, the regional medical director of the End of Life Options program, and the director of Outpatient Palliative Care at Kaiser Permanente Walnut Creek Medical Center in California.
Today, we're going to talk about the recently released ASCO Special Report: A Guide to Cancer Care Delivery During The COVID-19 Pandemic.
Dr. Srivastava was instrumental in developing the report. And we'll speak today about the guidance that the report provides for oncology practices as they return to more routine care delivery. Piyush, thank you so much for joining me today.
Dr. Piyush Srivastava: Thank you, Dr. Hudis for taking the time to speak with me. Just before we start, I just want to say that I do not have any relationships to disclose. So, thank you.
Dr. Clifford Hudis: Thank you very much for joining us today. Now, just to provide some context, today as we speak, we're approaching month five of the COVID-19 public health crisis in the United States. We've had more than 2.15 million confirmed cases of the virus and well over 100,000 deaths.
In fact, as we record this today, several of the largest population states in the United States-- California, Texas, and Florida-- are just reporting their largest single-day increases in cases and the health care systems in some of their big cities are approaching the kind of near breaking point that we saw earlier in New York. So, the problem is still very much with us.
When the outbreak began, oncology practices nationwide immediately began making operational changes designed to protect the safety of patients and the safety of staff. This meant adjusting to resource shortages that were unfolding and complying with national and state restrictions on elective procedures, among many other things.
Today, communities across the country are in varying states of recovery. And as I just described, some of them actually are probably pausing their recovery right now. Either way, they are facing a real transition in terms of oncology practice. And some are returning to something more like routine care while continuing to be acutely attuned to protecting the health and safety of both patients and staff.
So, Dr. Srivastava, could you start us off and tell our listeners just a little bit about what's happening in your own practice and how you have been adapting to the changing circumstances?
Dr. Piyush Srivastava: Of course. I would be very honored to share my experiences at Kaiser Permanente in Northern California. So, at the start of the pandemic, we were very fortunate to be nicely set up to provide care remotely. We've had a very strong existing telehealth structure. So, we were quickly able to adapt to the pandemic situation.
Initially, we nearly went 100% remote, with doing all of our new consults and chemo checks via video visits and telephone visits. If a patient needed some more attention, to be seen by a care practitioner, many times that we would coordinate with the on-call physician on site, who would see the patient on the chemotherapy infusion chair.
We also looked as an institution which services we could provide remotely and take off site and so that we didn't need to bring the patients into the cancer center. For example, we activated our home health nursing team to be able to provide port flushes in the home setting.
We also made a very conscientious effort to see what treatments and what procedures that we could postpone or actually decrease the frequency or increase the timing in between events. For example, bisphosphonate administration and port flushes, which we increased to do every three months.
What was extremely eye opening and inspiring to me is a large organization such as Kaiser Permanente was extremely nimble and flexible and was able to respond to the outside pressures. I believe, when I speak to my colleagues across the country, that many people experienced the same things with their institutions. And their institutions responded very flexibly to the ongoing pandemic.
Dr. Clifford Hudis: Thanks very much. It's really interesting, I think for me, and I'm sure for many of our listeners, to hear how you adapted but also to compare that with their own experiences. It sounds to me like some of the key features were clear eye on the safety of patients and staff but also having a structure that respected the needs of the clinicians from the beginning. And then, of course, understood that the flexibility overall was a key attribute. And I just think that's something that many people will be reflecting on.
As we hit it from that one in a sense, forgive me, but anecdote, which is how one center, one operation adapted, I wonder if you could talk a little bit about ASCO's role in providing the more general guidance that you helped to develop. Why did this society feel it was necessary to provide guidance at that level?
Dr. Piyush Srivastava: Yes. So, as we are all extremely aware, many individual health care professionals, institutions, and health systems look to ASCO for mentorship when it comes to oncology care. So, this current pandemic was no different. I believe ASCO felt a strong duty and a responsibility to partner with the oncology world to ensure the highest quality and efficiency of cancer care and delivery through this pandemic.
Also, the beginning of the pandemic, there was a lack of really clear guidance from federal and state agencies. So, cancer care providers and administrators looked to ASCO to help develop their plans of providing care during the pandemic. Now, also opening and ramping up as well, they're looking to us.
Dr. Clifford Hudis: I see. So, as we think about staff at ASCO headquarters, it's really pretty straightforward on a daily basis. Our decisions to open headquarters, for example, or not are predicated, number one, on the safety of our staff. So, when you look at the Special Report, what would you say was the one or the several overarching goals that drove the development of the Special Report?
Dr. Piyush Srivastava: So, when constructing the report, we did very much realize that there are so many varied practices across the country, really around the world, right? For example, we have small rural practices. We have medium-sized private practices. We have academic centers, and we have hospital systems. And all these organizations look to ASCO for cancer guidance and guidance to cancer care delivery.
By no way were we going to be able to solve individual operational care delivery issues for each practice. So, the Special Report is made to serve, if you will, as a starting point or a launching pad for individual institutions to develop their own policies and operational adjustments.
So, what I would like to do now is maybe just dive a little bit deeper into some of the specific policies and practices that were outlined in the report. And as I look at it, it was really broken down into stages of patient care.
So, for example, before a patient even arrives on site, many practices are in a sense pre-screening them or triaging them. What are some of the methods that you have seen put into place and that have been effective that we should recommend to practices just getting open?
So, the Special Report lists out very clearly sequential steps to consider in safely bringing patients into cancer centers. And I'll highlight a few of them, which I feel is extremely important. The first step is to actually reach out to the patient well before their scheduled visit to the cancer center. So, if we can call these patients and family members well before their visit, we can educate them as to the process that they'll experience when they come into the cancer center.
Allow them to ask questions and to give the reasoning behind or the why to we are doing this. I think that will go a long way. So transparent communication, I think, will reduce anxiety and fear.
I also believe an effective second step was to do a quick check in, anywhere from 12 to 48, 72 hours prior to the actual visit, depending on what your operations would allow, just to check in to make sure that you're screening for the COVID symptoms and the patient doesn't test positive to any of those symptoms.
I may just add also in the first step, when you reach out to the patient well before their appointment, that's also a good time to screen for COVID questions. And then a third implementation can be as a single point of entry.
So, when a patient comes into the cancer center, there's one point of entry so that way a temperature could be checked, a patient could be screened again for those COVID symptom questions. And so that when that patient arrives inside the cancer center, there's been essentially three checks and balances of checking for COVID-19 symptoms.
So, this provides obviously the safety to minimize the risk of bringing COVID into the cancer center. But I also think an extremely important added benefit is that the staff and providers will feel confident and safe that the institution has done these many different steps to ensure their safety as well and to minimize their risk of exposure to COVID.
Dr. Clifford Hudis: I see. So that's one part of this. Now, the implication in all of this is the volume coming through the clinics is likely to be lower. And one of the ways in which it is controlled, of course, is through the reduction of less critical face-to-face encounters and arguably an increase in telemedicine. What are some of the considerations that you think oncology practices should factor into their use of telemedicine in care delivery?
Dr. Piyush Srivastava: Yeah. That's actually a fantastic question, because telemedicine has really-- well, telemedicine was forced upon most institutions. And the institutions had to really find an effective way to provide care remotely. So, it's a very interesting and important topic. For example, I think one thing that I personally struggled with, and I think my institution struggled with is, who is the right patient for telemedicine?
So, the report talks about specific patient categories that you can think of that would be easier to provide patient care remotely. So, for example, those that are not requiring in-person physical exam, those who may not actually actively be getting chemo treatment, those that don't need any in-office diagnostics. So, don't necessarily need lab work tied to that appointment or you don't necessarily need imaging exams at that moment.
Other visits that the report recommends to think about is follow up. So, follow up could be done through telemedicine. Or those that are on oral oncolytic treatments. And so, it's a quick check in just to make sure that they're taking the medication and the adherence is high could be done by video or by phone.
A couple of things to consider with telemedicine, obviously, is the audio and visual capabilities. And so even in the Bay Area in California, we do have spots that don't have the best reception. And so that can become problematic. So that's something to also think about.
The other sort of counterbalance or countermeasure to this is just to make sure that patients feel that they're being taken care of and they feel satisfied. So in my own practice, I've now adopted that when we finish a video visit or we finish a telephone visit, I let the patient know that I have felt comfortable with the interaction and that I felt that I was able to accomplish the care plan and execute the care plan as needed by the video and phone. But then I ask them, do they feel comfortable and are they OK proceeding this way or do they prefer face-to-face visit.
Dr. Clifford Hudis: Yeah. I think that's an interesting observation about telemedicine. I think everybody is feeling their way right now and learning. And we want to be careful not to go too far away from the direct physical encounter since so much can be lost without those subtle cues from body language and classic physical findings as well. Now, coming back once more to the workforce, the report addresses how we maintain a healthy workforce.
And it specifically, I think, gets into questions of testing and scheduling and even dealing with stress. Can you walk through that a little more about antibody testing or saliva or nasal swabs and the frequency and exactly what facilities and practices should be thinking about for their staff?
Dr. Piyush Srivastava: Sure. And this is an extremely hot topic, and the interesting thing about this topic is it can vary widely just depending on what's available at that moment in your location, what the county is ordaining and what the state is ordaining as well. So, there's a bit of variability.
But what the Special Report does very nicely, it lays out considerations for institutions to think about when they are caring for the workforce, both physically and emotionally. So, this Special Report lays out some PPE guidelines, and really, it's based on what the CDC is recommending.
And as we know, as one of the largest sort of scientific research-based organizations, it's important that we bring the CDC's sentiment forward when we talk about PPE, especially with PPE stewardship as this goes on for some time, we may have some issues with the supply chain.
The other thing the Special Report calls out is to really have institutions make sure that they are putting their health care practitioners in the forefront. So, checking in with health care practitioners to make sure that they are not ill, that they're feeling OK, that they haven't been exposed to anybody outside of the medical system. And I think what's really, really special about this report is that it really talks to the practitioner's well-being. I think this is scary for any provider in the front line.
We are also worried about our own health and what we can bring back to our loved ones outside of the medical center. But also, I think all of us as oncology providers are feeling a little disillusioned and a little saddened, because we are not able to provide oncology care like we normally have been.
And so that's a huge adjustment for the oncology provider. And of course, that comes with some moral distress. So, the report also calls out for institutions to check in with their health care providers to make sure that their emotional well-being is good and to also make sure that they feel that their family and loved ones are safe at home. So, I think that was a really added benefit.
Dr. Clifford Hudis: Yes. Really important to acknowledge the importance of all of that to the individuals. And it is not just about narrowly the safety of the surfaces and workspaces they're in, but really in a sense their holistic experience in life. I want to turn to the broad public approach to cancer care and focus on the corners that we cut, if you will, in going into this crisis, the compromises with old ways of doing things that we very quickly adopted.
The report focuses on some of those immediate short-term steps that we took. And I think looking at the effectiveness of that, I can tell you that I asked the ASCO leadership on the staff side and on the volunteer side why those adaptations couldn't just be our new permanent normal.
That is to say, if it was safe enough to do telehealth in April of 2020, why isn't it safe enough to do it forever? So that was the nidus of our Road to Recovery Task Force. And I know you sit on the group focused on care delivery. What do you think we can expect from that effort?
Dr. Piyush Srivastava: Yeah. And this is fantastic. I am honored to be sitting on the Road to Recovery Task Force, because I think this is an issue that's facing every oncology care provider in the country and, frankly, around the globe. And the task force is composed of a group of really active and very intelligent oncology providers who are putting their minds together collaboratively to see how we can continue to provide cancer care in an efficient and in a high-quality manner moving forward beyond the pandemic.
And as you said very nicely, Dr. Hudis, we have gained several insights through our care over the last few months, and can we harness those insights and continue to practice oncology in a very efficient and high-quality manner?
So, the task force is extremely comprehensive. The group is addressing several buckets, if you will, that are very pertinent to oncology care and delivery. So, they're looking at health equity. They're looking at resetting clinic and patient appointments.
They're looking at practice operations, telemedicine, home infusion. I know that's something that we've all been grappling with. Financial assistance to practices, which is extremely important when we look at the economy around us.
Quality reporting and measurements. So, we want to make sure-- we want to challenge ourselves to make sure that we are practicing the highest-quality cancer care that we can. Utilization management. So that's also extremely important as we are looking at the economy around us.
Psychosocial impact on patients. So, this has been obviously extremely traumatic for patients in their very vulnerable state. The task force also is looking at provider well-being, which once again, I can't reinforce how important that is as we go back into somewhat normal operations, whatever that normal may be, but looking at the sort of stress that the providers are feeling in that.
And then ongoing preparedness I think, which is extremely essential, because we just don't know what the virus will do over the next year and what might also come in the future. So, the task force is extremely collaborative, extremely thorough. And it is a group of very active individuals on oncology care that are bringing their brilliant minds together to come up with some guidance.
Dr. Clifford Hudis: Well, I think that's really great. As we wrap up now, I wonder if at the highest level if there's a single or several major takeaways that you want listeners and our entire community to take away from these recommendations?
Dr. Piyush Srivastava: Yeah. You know, I've actually had some time to reflect. It's been a very privileged experience for me to be a part of this and to be a listener and to be a learner from all these brilliant minds around me who are putting their heads together to accomplish this. I find that recommendations in the Special Report to be very thoughtful and very comprehensive.
I do hope practices remember that these are actually guidelines to help them develop and change policies at individual institutions. I also hope that oncology practitioners and administrators remember that we're all in this together. And so, there is going to be an ever-changing environment.
So, I hope that this report is just a start of a collaboration that can be ongoing with ASCO and with oncology providers around the world. I am fully confident that ASCO is a tremendous and a large resource for us in the oncology world to be able to accomplish collaboration and to actually uplift and maintain cancer care during and after the pandemic.
Dr. Clifford Hudis: Well, that's really, I think, is nice and as great and complete a summary as one could hope to hear. So I want to thank you, Dr. Srivastava, for speaking with me today. I'm really grateful to you for your time on this whole initiative and the effort that you've put to it as well as, of course, for the time today.
Dr. Piyush Srivastava: I appreciate it. It has been a great honor. And so, thank you very much to you, Dr. Hudis, and thank you very much to the ASCO staff, who do a tremendous job on a daily basis to make sure that we are doing the best we can.
Dr. Clifford Hudis: So, the Special Report, and later, ASCO's Road to Recovery, are all part of ASCO's larger commitment to providing information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer, both during the COVID-19 pandemic and then well beyond it.
We invite listeners to participate in the ASCO survey on COVID-19 in Oncology Registry or ASCO registry. This is a project where we are collecting and then sharing insights on how the virus impacts cancer care and cancer-patient outcomes during the COVID-19 pandemic.
We encourage all oncology practices to participate so that we will have the largest possible data set and represent the full diversity of patients and practices across the United States.
I'll remind you that you can find all of our COVID-19 resources and much more at asco.org. And until next time, I want to thank everyone for listening to this ASCO in Action podcast.
If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. And you can find all of the shows at podcast.asco.org.
Listen Now: Ethical Considerations on Allocating Scarce Resources During a Pandemic
In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Jonathan Marron, incoming Chair of ASCO’s Ethics Committee and a lead author of the new Ethics and Resource Scarcity: ASCO Recommendations for the Oncology Community During the COVID-19 Pandemic.
In this episode they discuss ASCO’s recommendations, why ASCO developed this guidance, and what patients, families, and the entire medical community need to know about allocating limited resources during the COVID-19 Pandemic.
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Transcript
Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offers enriching insights into the world of cancer care. You can find all of our shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series, where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.
My name is Dr. Clifford Hudis, and I'm the CEO of ASCO. And I'm proud to serve as the host of the ASCO in Action podcast series. Today, I'm very pleased to be joined by Dr. Jonathan Marron, incoming chair of ASCO's Ethics Committee and a lead author of ASCO's recent recommendations for the oncology community on ethically managing scarce resources during the COVID-19 pandemic.
Dr. Marron is also a bioethicist at Boston Children's Hospital, a pediatric oncologist at Dana Farber Cancer Institute, and he is on the Center for Bioethics teaching faculty at Harvard Medical School. Today, we're going to talk about those recommendations. And I'll note that they were published just recently as a special article just in early April in the Journal of Clinical Oncology. We'll focus specifically on the reasons that ASCO took this step and what it is that oncologists, patients, families, and the entire cancer care community need to know about this issue. Dr. Marron, thank you so much for joining me today.
Dr. Jonathan Marron: Thank you so much, Dr. Hudis. It's really a pleasure to be speaking with you, and an honor as well. Before we get started, I do want to just point out that I have no conflicts of interest to disclose.
Dr. Clifford Hudis: Well, that's great. Now, just to provide some context as we start this discussion, it's the middle of May as we're recording this. In the United States, the COVID-19 public health crisis bubbled up to awareness a little bit in January, became seemingly near threat in February, and seemed in the public's eye, I think, to breach our shores at the beginning to middle of March. So, we're about four months, more or less, into this public health crisis.
The US has had now about a million and a half-confirmed cases of the virus. And I think this week, we crossed the 90,000 number in terms of deaths from the virus. From the very early days, there was-- and we all remember this-- an extraordinarily emotional and widespread concern that medical resources, and especially ventilators, but also medications, as well as space, critical and intensive care beds-- those three things, that they would be stretched, that some communities would be especially hard hit, and that, as a consequence, access to those resources might be limited.
And when that arose as a concern, what followed, especially for people who work in this field, and bioethicists in general, as well as everyday clinicians, was the very real possibility that they would be forced to make some painful and difficult choices. And I'll say some of our members wrote about these experiences as well in ASCO Connection and elsewhere. So, can you now maybe help our listeners understand why ASCO in particular thought that this situation needed to be addressed and why we decided to provide the very specific guidance that you took part in creating in the form of these recommendations?
Dr. Jonathan Marron: Absolutely. So you really highlighted a couple of the main questions and concerns that we had that we wanted to do our best to address, in the sense that at the outset of the pandemic, it was really difficult to tell what direction things were going to go and just how bad everything was going to get. Seeing the experience in China and seeing the experience in Italy, there was significant concern that, as you mentioned, our health care system would not be able to support the critical care needs that we would have. There is a long history of people thinking about how to utilize and best utilize resources like this in the setting of scarcity.
One of the concerns that comes up whenever you have to make these difficult or realistically impossible choices is how you're going to do so. And so really, that's where we came, as oncologists and as the ASCO community, to try to figure out how we could best represent the oncology community and to ensure that cancer unto itself was not going to keep a given patient from having a fair chance to access these potentially lifesaving resources, even in the setting of a public health crisis like this, even in the setting of scarce resources.
Dr. Clifford Hudis: So, I remember as this was being developed having conversations with, I think, you and other members of the panel. I'm going to push a little bit on at least one of the areas that I think is really a concern but can be misunderstood. And that is this high-level statement you just made that people with-- if I understood correctly-- that people with cancer might find themselves discriminated against in these moments of triage, fundamentally. There's one ventilator. There are three patients at need. And God forbid we're ever in this situation-- how do you decide who gets it.
On the one hand, of course, there's a fairness doctrine. But on the other, there is a medical reality. And cancer is not one thing. So, could you just talk a little bit about what we mean when we say protecting the cancer patients? And let me be clear. We're not saying that cancer as a diagnosis, stage, prognosis should be ignored exactly, right?
Dr. Jonathan Marron: Absolutely. And I think what you said there really is one of the most, if not the most, important aspects here, that there are a couple of different ways that you can go about trying to take, as the example that you had of the three patients, and decide which of those three will get the ventilator. If not the perhaps fairest way would be simply to make a choice at random and say each of those three individuals has an equal chance at it, and we'll flip a coin or do some other random way of deciding who will get it. That's certainly fair.
But some people would say, you know what? They may not be equal in all ways. And if we're trying to maximize our resources and maximize the potential outcome benefits of these scarce resources, we want to do something more than just do something-- choose randomly. And we've actually learned in the past from work with community groups that people don't love the idea of randomly choosing things like this, in a public health emergency or otherwise.
And so then-- the question, then, is OK, so how are you going to make that choice. If we're trying to maximize health care outcomes, and which you usually think about that being survival, we want to use medical information. But then the question is, what is the information that should be used.
So, one of the concerns is that there could be certain disease processes, cancer or otherwise, that would be seen as exclusion criteria. That's to say, OK, we have these three patients. We have one ventilator. Patient one has cancer, so therefore we're going to not even give them a chance at that ventilator. And that's really where this comes in. That's not the way to do this. Cancer absolutely should come into the consideration. But that patient's specific cancer-- their diagnosis, their prognosis, the medical information-- the best medical information that we have, the best evidence-based medical information that we have about their specific disease so that we can make an informed decision, or at least a maximally informed decision about who is the most likely to survive if they are given access to the ventilator or ICU bed or whatever it might be.
Dr. Clifford Hudis: Yeah, I think this was one of the areas that you had to read somewhat carefully and be patient to understand the context, because if I understand correctly-- and with no disrespect to our colleagues outside of oncology-- one concern is that in the ER, a patient who once had cancer might just be, in a blanket way, discriminated against. But look, I was a breast cancer doc for 30 years. Most of my patients were, frankly, cured. And the fact that they had breast cancer in 1996 is of essentially no meaningful relevance to any medical decision, almost. I'm oversimplifying it here, rather.
But our concern, I think, was that in the front lines, under duress and pressure, that mistaken judgments might be made, and we wanted to advocate for that. Is that-- I may not have said that so elegantly. But is that-- that was one of the concerns in the other direction, right?
Dr. Jonathan Marron: Absolutely, yeah. And it's certainly conceivable that somebody, in a very well-intentioned way, would think that OK, this patient currently has cancer or at some point in the past had cancer. And as wonderful as the electronic record is, sometimes it can be difficult to tell if something is a current medical problem or a past one. But either way, simply the diagnosis of cancer is not the be-all, end-all. And there needs to be a thoughtful and ethically rigorous process by which these decisions are made. And that's what we hoped to inform with the paper and with the recommendations.
You know, it's interesting. And if I may just think of the sweep of time, I always put things in the ASCO context. So, the society was founded in '64. The medical oncology boards were in the mid-70s for the first time. The curative systemic therapies for testes cancer, for the lymphomas were a little before that, obviously, and in that general era. It is quite a testimony, when you think about it, to the advances in oncology that we're now worried that people will, in a sense, make too much in the negative direction about prognosis of a cancer diagnosis.
Dr. Clifford Hudis: And I'm thinking of the last few years, where suddenly there are tranches of survivors of melanoma and non-small-cell lung cancer and other diseases that historically had a very poor prognosis, and now they may still have, on average, a bad prognosis. But there are survivors and long-term survivors with formerly incurable diseases. They need to be protected, in a sense, from this one-size-fits-all judgment, right?
Dr. Jonathan Marron: Absolutely, yeah. And as a pediatric oncologist, I run into that every day that people assume that, oh, my gosh, children who are diagnosed with cancer, that they're dying left and right. And people are generally quite surprised to hear that we have an 85% survival rate in children with cancer. So that certainly would be a concern in that population as well, that if there were the setting of resource scarcity that a child could come in and say, OK, well, they have cancer, even if it's active cancer, but they, in many cases, would be expected to have a very good chance of survival.
Dr. Clifford Hudis: It's interesting you bring that up, because I will say in a distantly related aside, certainly one of the more interesting and repetitively surprising conversations many of us have is the one that involves pediatric oncology with friends and neighbors or whatever who aren't that familiar. They're always surprised at the high success rate in that field. And it just makes the point that we can't let a diagnosis stand as the only interpretable fact. So, look, these recommendations establish an important principle. A cancer diagnosis alone should not keep a patient from a fair chance to access potentially life-threatening-- or rather lifesaving, sorry, resources, even during a public health crisis.
But let's go a step further. One of the other recommendations in there were that decisions regarding allocation of scarce resources should be separated from bedside decision-making. This one, I struggled with as a reader as well. And I wonder if you could explain to our listeners what the intent or thinking behind this recommendation would be. As I ask that question, in my mind's eye, I picture I'm called to the ER. The ER doc is looking at my patient's dropping O2 sat and is turning to me for advice and guidance and understanding of the disease specificity or the specific disease circumstances in this patient so they can make the triage decision. And I'm struggling to understand what we actually mean by decisions regarding allocation of scarce resources should be separated from the bedside.
Dr. Jonathan Marron: So ultimately, that piece comes down to the fact that we as humans and decision-makers are imperfect. And it would be unreasonable and probably impossible to expect that any one of us, as a clinician or just as a person, could reasonably weigh all of these different things simultaneously, because there is ultimately a huge conflict of interest in saying that I am the clinician taking care of this patient in front of me, but simultaneously, my job is to steward the resources for my institution or, even more broadly, the resources for the entirety of the country or whatever I might consider to be my patient population. And so what we are trying to-- the message we were trying to send with that piece is not only that it shouldn't be the oncologist who's making that resource allocation decision, but it's actually not the emergency room clinician who should be either, because it's just completely unreasonable to expect someone at the bedside to be weighing those two things at the same time and to be making an unbiased decision.
Dr. Clifford Hudis: Well, apart from the pandemic and the specific kinds of acute resource shortages that the paper addresses, the truth of the matter is, we've been talking about finite healthcare resources and hard choices for years. And these questions often are raised in the context of oncology. So I want in that way to just ask you about something that you mentioned at the very beginning, but I'm going to push you to a more precise answer, the recommendation that says allocation of scarce resources in a pandemic should be based on maximizing health benefits. And you alluded to that a little bit.
So, can you just expand a little bit on what it is you mean? You've said overall survival is often taken as one. But of course, there are trade-offs. There's quality-of-life issues. There are a number of people who might benefit modestly, more people, fewer people, benefiting more deeply, whatever it is. So, I won't hold you to this exactly, although it's being recorded. But what do you think should be the goal when we talk about maximizing health benefits? What exactly does that mean?
Dr. Jonathan Marron: So, this is really where we get into the weeds with this, as you were sort of alluding to. So certainly, we want to save the most lives. I think there is general agreement from most people out there that that's a reasonable and a fair way to look at this. One of the questions that's been debated most over these past couple of months as we've been thinking about these things, perhaps more than we ever have before, is whether we want to somehow integrate the idea of saving the most life years.
So, what do I mean there? So, the idea that a person who is expected to live five years, do we think about that life differently than a person who's expected to live another 45 years? Intuitively, I think many people would say, oh, well, if we have to make that choice, that awful, impossible, choice, we should save the person who is going to live 45 years over the one who's going to live five years.
That's getting at this question of saving the most life years, number of total years of life. And so with that, I'll ask you, is there anything else you think ASCO members or the cancer care community or health care institutions should understand about this work in this moment? Is there anything their families and patients you would want to-- is there anything else you'd want them to know about this that we haven't touched on?
I mean, I think one really important but really challenging piece about all this is the role of communication, in every sense of the word, that these are absolutely unprecedented times. And these types of decisions, if and when they have to be made, are luckily things that-- the kind of decisions that we don't typically ever have to make. And so if they have to be made, ensuring that oncologists who have the long-standing relationship with patients and families take on a role of communicating with patients and with their families as much as they can to explain why these decisions are being made, and why they have to be made, to ensure that everybody is on the same page I think is really important.
What makes this even more difficult is the fact that most hospitals now have visitor policies such that families and caregivers often, if not most times, are not able to be at the bedside of patients, which makes this only that much harder, but makes communication that much more important.
I would want to highlight something you just said, because it resonates, at least for me, and I think for many in our in our community. And that is communication. At root, of all of this is dependent and made easier and smoother by high-quality communications.
Dr. Clifford Hudis: And I would actually extend what you said by pointing out that it also includes discussions about intentions and desires on the part of patients. And this is something we who take care of cancer patients, I think, do try to spend a lot of time on. This discussion is much easier if a patient who does know about a life-limiting prognosis is clear about what they want. Certainly, for the whole team, some of the ethical dilemmas might be minimized that way, right?
Dr. Jonathan Marron: Yeah, I couldn't say that better. That's one thing we try to highlight in the guidelines as well, that we consider advance-care planning and having goals-of-care discussions to be really at the core of clinical oncology practice. And that continues in the setting of this pandemic. And if anything, it's only more important.
Dr. Clifford Hudis: Well, I think this is really great. I hope that listeners find this discussion intriguing and go and take a more in-depth look at the actual publication. I want to point out that the recommendations that we've been discussing are just one part of ASCO's longstanding commitment to provide information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer throughout their journeys, and also during this COVID-19 pandemic. That is, what we're doing here is not unique to this pandemic moment, even if the acuity of the need is heightened.
There are some other resources that you should be aware of, including patient care guidance for oncologists who treat patients with cancer during the COVID-19 pandemic. There are guidances available for practices on how to adjust our policies in response to the virus and, just recently, on how to begin to return to more normal styles of work. There are also updates on federal activities that have been aimed at responding to this crisis. And everybody knows that this has been a very fast-paced time of change.
We recently launched the ASCO survey on COVID-19 in Oncology Registry or ASCO Registry. And our goal is to collect data and share insights on how the virus has impacted cancer care, but also cancer patient outcomes throughout the COVID-19 pandemic. And we encourage all oncology practices to participate so that we can gain the largest data set possible, and therefore represent the diverse population of patients and practices around the United States.
I want to remind listeners you can find all of these resources and a whole lot more at ASCO.org. There is also patient-focused information available at Cancer.net. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, you should take the time to give us a rating or review on Apple Podcasts or wherever you might listen. And while you're there, be sure to subscribe so that you never, ever miss an episode. I want to thank Dr. Marron for joining us today.
Dr. Jonathan Marron: Thank you, Dr. Hudis. It was an absolute pleasure to join you.
Dr. Clifford Hudis: And lastly, I want to remind you that the ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at Podcast.ASCO.org.
ASCO Guidelines
Oncology Medical Homes: ASCO-COA Standards Update
Ms. Kim Woofter and Dr. John Cox discuss the latest updates to the evidence-based standards on oncology medical homes developed by ASCO and COA. These standards serve as the basis for the ASCO Certified program. They share the new and revised standards around topics including the culture of safety and just culture in oncology practice, geriatric assessment and geriatric assessment-guided management, and multidisciplinary team management. They expand on the importance of these standards for clinicians and oncology practices to ensure every patient receives optimal care.
Read the complete standards, “Oncology Medical Homes: ASCO-Community Oncology Alliance Standards Update” at www.asco.org/standards.
TRANSCRIPT
These standards, clinical tools, and resources are available at www.asco.org/standards. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the JCO Oncology Practice, https://ascopubs.org/doi/10.1200/OP-25-00498
Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts.
My name is Brittany Harvey, and today I'm interviewing Ms. Kim Woofter, a registered nurse in practice leadership and administration from AC3 Inc in South Bend, Indiana, and Dr. John Cox, a medical oncologist and adjunct faculty member from UT Southwestern Medical Center in Dallas, Texas, co-chairs on "Oncology Medical Homes, American Society of Clinical Oncology – Community Oncology Alliance Standards." Thank you for being here today, Ms. Woofter and Dr. Cox.
Dr. John Cox: You bet.
Ms. Kim Woofter: Thank you.
Brittany Harvey: And then before we discuss these standards, I'd just like to note that ASCO takes great care in the development of its standards and ensuring that the ASCO Conflict of Interest Policy is followed for each guidance product. The disclosures of potential conflicts of interest for the expert panel, including Dr. Cox and Ms. Woofter, who have joined us here today, are available online with the publication of the standards in JCO Oncology Practice, which is linked in the show notes.
So then, to dive into what we're here today to talk about, Dr. Cox, could you start us off by explaining what prompted an update to these ASCO-COA standards and what the scope of this update is?
Dr. John Cox: Well, the ASCO-COA standards relative to defining and outlining Oncology Medical Home were initially published four or five years ago. At the time, we planned a regular update of the standards. So, in essence, this is a planned update. The whole program is built on the idea of continuous improvement. So, this update and future updates are prompted and defined by our literature, our science, the science of care delivery, and new developments and insights gained from studies and evaluations of care delivery methods, and informed by the practice. These standards are in place to underpin a program of care delivery by ASCO, the ASCO Certified, and as practices engage in this program, we are learning from them. The whole idea is to enlarge and improve how patients are cared for in practice.
Brittany Harvey: Absolutely. It's great to have this iterative process to continue to review the evidence and update these standards that form the basis for ASCO Certified.
So then, following that background, Ms. Woofter, I'd like to review the key points of the revised standards for our listeners. First, how do the revised standards address the culture of safety and just culture in oncology practice?
Ms. Kim Woofter: I think safety is of utmost importance to all of us. So let me say that first and foremost. And what we know in oncology is our QOPI standards already address safety in the infusion suite process. So, safe delivery of chemotherapy agents and antineoplastics. It also talked about near misses and medication errors - absolutely essential, for sure.
But what we need to do is look at a more systemic approach to safety because we know is processes throughout an organization they’ll often cause you trouble. To do that, we know you need what we call a just culture, which is a very common term in today's workplace. But what it really means is it's a culture of open reporting of any potential for error, any potential for malfunction, and it can be in any place in the organization. So, what we are doing in our new standard is to say, look at your entire processes throughout the organization, and approach that in an open-minded way so that people don't feel scared to report things, and it's a really positive approach to intervening early and making sure that errors don't occur anywhere in the workplace.
Brittany Harvey: Taking that systemic approach to look at overarching processes seems really key to ensuring safety in oncology practices.
So then, the next new section, Dr. Cox, what are the new OMH standards surrounding geriatric assessment and geriatric assessment–guided management?
Dr. John Cox: This is a challenging update for our standards. As many folks in practice recognize, there is a deep literature on recognizing the geriatric population in oncology. Geriatric - those in my age group over age 60, 65 - make up the majority of cancer patients in this country. And yet, there are many aspects that should be taken into account as you address treatment decisions in this population.
ASCO's recognized this. There has been a guideline previously on geriatric assessment. It's been updated, and we really felt it's time that it be incorporated in any iteration of what oncology care delivery means, so, within the oncology medical home standards. In short, what the standard outlines is that practices that are using these standards, that are using this benchmark, should have a geriatric assessment for patients within the practice care and use that information to guide management. Now, the standard allows wide exploration of how practices meet this standard, but it really puts on the table that if an oncology practice in the United States, or anywhere in the world really, is adhering to a good practice, that they're going to include and recognize these assessments in practice.
Ms. Kim Woofter: I would like to add that this is a highly discussed and reviewed standard. Many of our community practices were concerned that they would have the time and manpower to perform this assessment. We all know it reduces toxicities if done appropriately at treatment planning, and so the outcomes are better. And we really left it to the practices to define how they're going to implement it, understanding that it will evolve to every single patient, but maybe day one, it was a step approach to be able to implement. So, I was really proud of the team that - the expert panel - that said, okay, let's step into this, but we do think it's essential.
Brittany Harvey: Absolutely. It's important to recognize that practices may have limited resources and time, and implementing it in the way that makes sense for them allows this to be a standard that can be used in practice. And it's great to have this geriatric assessment guideline integrated into these standards to improve care delivery. And we can provide a link to that guideline in the show notes of this episode as well (Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update).
So then, following that section of the standards, Ms. Woofter, how do the updated standards now address multidisciplinary team management?
Ms. Kim Woofter: Well, we address multidisciplinary team management in a more comprehensive way in the updated standard. We always thought that that was a critical piece when doing treatment planning, and we kind of highlighted it in a bigger way, understanding that not everybody has the same resources available at the time of treatment planning. And again, this was a much-discussed standard, in that that multidisciplinary team approach doesn't necessarily have to be in a tumor board or a prospective analysis of every case. It is actually a conversation between specialists, between the surgeon and pathologist and the medical oncologist. And we are saying, do what works for you, but we know that that team approach, every specialty coming to the table at time of treatment planning, truly provides better outcomes for our patients. And so we kind of reiterated that, understanding that again, it doesn't have to be a formal tumor board, but it has to be a dialogue between specialties. And we highlighted that again in the new standard.
Brittany Harvey: Open communication of all team members is really critical to providing optimal care.
Dr. Cox, I'd like to ask you, in your view, how will these updated standards impact both clinicians and oncology practices?
Dr. John Cox: Well, our whole goal with discussing a comprehensive care model for oncology practice is to have a benchmark, to have an iteration of what good oncology care delivery looks like. So, our hope is that practices, all practices, whether you're participating formally in ASCO Certified, the marquee quality program for ASCO, or if you are simply running a practice or a team within an academic environment or institutional environment, these standards are to apply across the board wherever oncology is practiced - that you can look at these standards as a benchmark and compare what you are doing in your practice and where are the gaps. So ideally, we drive improved care across the board.
You know, one thing I've learned over the last couple of years as ASCO Certified is getting spun up and using and implementing these standards, is practices are remarkably innovative. We've learned a lot by seeing how pilot practices have met the standards, and that's gone into informing how we can improve care delivery for all of our practices and, importantly, for the team members who are delivering this care. The fourth rail of burnout and the like is inefficiency that occurs in practice. And when you know you've got a good, spun-up, effective team, less burnout, less stress for practice. I hope clinicians and oncology practices will use this to help drive improvements in their care and gain insight into how they can approach practice problems in a better way.
Kim, you've been leading practices. I have to ask you, your thoughts in leaning into this question.
Ms. Kim Woofter: I think very well said, I will say that first. And what I love about this is for practice leaders who are new to our ecosystem, if you will, they need a playbook. It's “Where do I begin?” And Dr. Cox said it very well, no one does everything perfectly day one, but it's a step-by-step self-assessment approach to say, “How do I get to this gold standard?” I really love the standards because they are very comprehensive, everything from treatment planning to end of life. So it's the spectrum of the care we deliver in the oncology setting.
So as a leader and an administrator, it is the standard I want all of my departments to understand, adhere to, and engage, and be excited about. We now have a baseline approach, and what's even more important, these standards will evolve as our intelligence evolves, as literature evolves. It's a system that will always grow and change, and that's what we love about it. It's not a one-and-done. So, I'm very proud of the fact that it gives them a road map.
Brittany Harvey: Yes, these evidence-based standards provide a critical foundation for practices in ASCO Certified, for those team members you mentioned, and for quality improvement beyond just those individuals and practices as well.
So then finally, to wrap us up, Ms. Woofter, what do these revised standards mean for patients receiving cancer treatment?
Ms. Kim Woofter: Well, I think that's the most exciting part, is we all do this for our patients and the best outcomes for our patients and the best treatment plans for our patients and their families. And these standards, that is their core, their absolute core. So what it's going to do for a patient is they can say, “Am I at a practice that implements ASCO standards?” And if that is a ‘yes’, there's a confidence that, “I am in an evidence-based medicine thinking practice, I have a team around me, they will care for me not only at time of treatment planning but at the time of end of life, they will help me be part of that decision-making, and they will give me resources available to me in my community.” So, it is a true comprehensive approach. As a patient, I have that comfort, that it is bigger than just a great doctor. It is a great team. As a patient, that would be very important to me and important to my family.
That being said, Kim Woofter would love every practice to be ASCO Certified. Understanding that that isn't feasible day one, just to know that the practice is implementing and engaging the standards is the great place to start. Every patient can't go to an ASCO Certified practice day one, but our dream would be that everyone would adhere to those standards, engage those standards, believe them, educate their staff on what they mean, so that patient outcomes and satisfaction will be optimized for everyone.
The other piece to this that we all know is if you give evidence-based medicine, cost-effective, efficient care, it's better for the system as a whole. And I'm not saying that insurance is our driver - certainly patient outcomes are our driver - but the whole ecosystem of oncology benefits when you do the right thing.
Dr. John Cox: It's hard to add anything to Kim's good statements, but I just highlight that this whole area began with the patient-centered medical home, and every time we've met, patients and how we deliver care to patients is top of mind. I think that reflects our community. It reflects oncology as a whole. I don't know any oncologist or practice that is focused on anything else as the prime goal.
Brittany Harvey: That's what I was just going to say. The ultimate goal here is to provide patient-centered care across where every single patient is receiving treatment and at every stage of that treatment.
So, I want to thank you both so much for your work to update these standards, to review the evidence, and discuss with the experts on the panel to come up with the solutions that will help drive quality improvement across care delivery. So, thank you for that, and thank you for your time today, Dr. Cox and Ms. Woofter.
And finally, thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the complete standards, go to www.asco.org/standards. You can also find many of our standards and interactive resources in the free ASCO Guidelines app, which is available on the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast, and be sure to subscribe so you never miss an episode.
The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.
Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Therapy for Stage IV NSCLC With Driver Alterations: ASCO Living Guideline Update 2025.1 Part 2
Dr. Joshua Reuss joints that podcast to discuss the latest changes to the living guideline on stage IV NSCLC with driver alterations. He discusses the new evidence for NSCLC with EGFR mutations and NRG1 fusions and how this impacts the latest recommendations from the panel. He shares ongoing research that the panel will review in the future for further updates to this living guideline, and puts the updated recommendations into context for clinicians treating patients with stage IV NSCLC.
Read the full living guideline update “Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2025.1” at www.asco.org/thoracic-cancer-guidelines
TRANSCRIPT
This guideline, clinical tools, and resources are available at www.asco.org/thoracic-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-25-01061
Brittany Harvey: Hello and welcome to the ASCO Guidelines Podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts.
My name is Brittany Harvey, and today I'm interviewing Dr. Joshua Reuss from Georgetown University, co-chair on "Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2025.1."
It's great to have you here today, Dr. Reuss.
Dr. Joshua Reuss: Thank you. Happy to be here.
Brittany Harvey: And then before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO conflict of interest policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Reuss, who has joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes.
So to dive into what we're here today to talk about, Dr. Reuss, this living clinical practice guideline for systemic therapy for patients with stage IV non–small cell lung cancer with driver alterations is updated on an ongoing basis. So what prompted this latest update to the recommendations?
Dr. Joshua Reuss: Yes, thank you. It's very important that we have living guidelines that are continuously updated. We obviously don't live in a static environment where things are non-changing, and we really need to apply the most up-to-date and current evidence to treat our patients with the most effective strategies, the most groundbreaking strategies. And so to have guidelines that can be disseminated, particularly these ASCO guidelines, to treating providers is incredibly important.
So, with any of these updates, we review ongoing studies, published work, for the quality of evidence to see if it's something that warrants making adjustments to our guidelines or at least incorporating the information so that providers can review it and incorporate this into their own personal decision-making.
So in this particular update, we reviewed evidence particularly pertaining to EGFR-mutated non–small cell lung cancer and non–small cell lung cancer harboring an NRG1 fusion.
Brittany Harvey: Yes, certainly there's a lot of new evidence in the advanced non–small cell lung cancer field, and so we appreciate the panel's continuous review of this evidence.
So then you just mentioned two separate areas where the panel reviewed new evidence. So starting with that first one, what updated evidence did the panel review on first-line treatment options for patients with EGFR alterations, and how did this impact the recommendations?
Dr. Joshua Reuss: Yes, so advanced EGFR-mutated non–small cell lung cancer, at least with classical activating alterations - that is our exon 19 deletions and our exon 21 L858R mutations - is something that's really evolved rapidly in the last few years. You know, for many years, we basically, for the frontline treatment setting, were saying, "Okay, we have a targeted therapy, osimertinib. We're going to give that, and we're going to see what effect we can get out of that," with, you know, a median time of duration of treatment response averaging around 18 months, knowing that there are some that that's a lot longer and some that are a lot shorter. But recently, we've seen a lot of data emerging on combination strategies. The guideline has already been updated to incorporate two of these combinations: osimertinib with chemotherapy based off of the FLAURA2 trial, and then the combination of amivantamab with lazertinib based off of the MARIPOSA trial. And that was data on progression-free survival that was published and led to those particular recommendations.
Now, more recently, we've seen data come out in smaller, randomized studies for other combinations. And more recently, we reviewed the RAMOSE study. So this was a phase II, open-label, randomized trial for patients with tyrosine kinase inhibitor–naive and really, treatment-naive advanced EGFR-mutated non–small cell lung cancer harboring one of these two classical EGFR alterations, randomized to either osimertinib alone or osimertinib with the combination of ramucirumab, which is an anti-VEGF agent. There's been a lot of data, preclinical and clinical, for the role of VEGF blockade, particularly in EGFR-mutated non–small cell lung cancer, so exploring the combination of this for synergy in the frontline setting really made a lot of sense.
So again, this was a phase II trial that randomized patients prospectively to one of these two regimens. The population here is really what we typically see with EGFR-mutated non–small cell lung cancer, predominantly a younger population - median age on this study was 65 - predominantly female - 71% female - and predominantly nonsmokers. Now, what this study showed was that at a median follow-up of 16.6 months, the progression-free survival favored the combination arm with a median progression-free survival of 24.8 months with the combination of osimertinib plus ramucirumab versus 15.6 months for osimertinib alone, for a hazard ratio of benefit of 0.55. The landmark one- and two-year endpoints for progression-free survival also favored the combination arm, and response rates were relatively comparable between groups, with overall adverse events being more frequent in the combination group, specifically high blood pressure, proteinuria, and epistaxis, which are our common adverse events related to VEGF-blocking agents.
So, it's good to see data in this space. Now, of note, though, this was a phase II study, so not a phase III level of evidence. In addition, when looking at the population, this was a randomized, multicenter study, but it was a US-only population. There was also some imbalance in the number of visits between arms, so the combination arm was seen more frequently than the arm that got osimertinib alone. Now, the imaging assessments were no different, but obviously this could lead to potential confounding, at least in timing of awareness of potential side effects and and things being brought to the attention of investigators. So very promising data here, but because, you know, of this being a phase II study, this actually led to no changes in the guideline at this time.
Brittany Harvey: Understood. Yes, as you mentioned prior, it's important to understand the full body of evidence and to review the trials even when it doesn't impact the recommendations.
Dr. Joshua Reuss: And I will say that, you know, there is an ongoing phase III study looking at a very similar combination. It's the phase III ECOG-ACRIN trial of the combination of osimertinib plus bevacizumab versus osimertinib alone in this specific population. So, you know, I think we will see phase III–level data for a combination of VEGF with osimertinib, but again, promising phase II data that did not lead to a change in the recommendation at this time.
Brittany Harvey: Absolutely. We'll look forward to that ongoing trial to learn more about combination in this patient population.
So then moving to that second patient population that you mentioned earlier where the panel reviewed evidence, what is the updated evidence and recommendation for patients with NRG1 fusions?
Dr. Joshua Reuss: Yeah, so this was an exciting update that we made more recently with this unique iteration of the living guidelines. So, NRG1 fusions, this is perhaps a newer kid on the block in terms of driver alterations that has been known to be identified in non–small cell lung cancer among other solid tumors. It is very rare, occurring in less than 1% of solid tumors, but something that we know is a unique oncogenic pathway that can lead to oncogenesis and cancer development, including in non–small cell lung cancer.
So up until now, unfortunately, there have not been targeted therapies that target this unique alteration. It's somewhat different than other driver alterations where there's a top-level signaling change in a protein. This is more of a ligand alteration that then alters, that then enables activation of more classical pathways, but again, through upregulation of a unique ligand. So a slightly different pathway but something that we know should be able to be targeted to promote patient survival for those with NRG1 fusions.
So the therapy here is a therapy called zenocutuzumab. It's an IgG1 bispecific antibody against HER2 and HER3. So it prevents the downstream dimerization and signaling that occurs as a result of this NRG1 fusion and upregulation of the NRG1 signal. This was, as you can imagine with a rare alteration, a large phase II registrational study that examined this in advanced solid tumors containing the NRG1 fusion. This is the NRG1 registrational trial.
And this study enrolled patients with advanced solid tumors who had progressed on prior therapy. Patients were treated with zenocutuzumab 750 milligrams IV every two weeks. Among 158 response-evaluable solid tumor patients, the response rate was 30%, median duration of response of 11.1 months, and a median progression-free survival of 6.8 months.
Now, in those with non–small cell lung cancer, that made up 93 response-evaluable patients, very similar outcomes there: a response rate of 29%, median duration of response of 12.7 months, and a median progression-free survival of 6.8 months. This therapy did appear to be well tolerated. The most common higher-grade emergent side effects - grade 3 or higher - were anemia occurring in 5% and elevated liver numbers occurring in 3%.
So this is a subsequent-line study, so this led to the updated recommendation that clinicians may offer zenocutuzumab in the subsequent-line setting for patients with advanced non–small cell lung cancer who harbor NRG1 fusions. So I think this does speak toward the incredible importance of next-generation sequencing and molecular testing for patients, particularly to include testing that looks at the RNA. These large fusions can sometimes be very challenging to detect on DNA sequencing platforms alone, so it's important to, if you have a high level of suspicion for an alteration like this, perhaps some of the mucinous adenocarcinomas where it's been challenging to find a driver alteration, and it's someone who is a never-smoker, really would want to include molecular testing that assesses the RNA level and not just the DNA.
Brittany Harvey: Absolutely. It's important to have all the biomarkers available so that clinicians are able to use that to inform their decision-making.
So then, given these changes in the guideline, what should clinicians know as they implement this latest living guideline update? And how do these changes impact patients?
Dr. Joshua Reuss: Yeah, I think talking in reverse order of what we just discussed here, there is a new guideline update for NRG1 fusions. So I think making sure that that's being evaluated, that clinicians are testing for that and really looking for that result that should be incorporated in in most next-generation large sequencing assays to get that result, but it's very important that that is not overlooked now that we do have a therapy that's available in the subsequent-line setting, though it is important to note that patients with NRG1 fusions, at least the limited data that there is suggests that the efficacy to standard chemoimmunotherapy regimens is overall poor. So physicians unfortunately might be facing this question for second-line therapy in patients with NRG1 fusions sooner rather than later.
For the former, for EGFR-altered non–small cell lung cancer and how do we incorporate VEGF-containing regimens into these patients? Our guideline top-level update did not change based off of review of this new study, but it's important for clinicians to know what other combinations may exist. You know, there are phase III studies looking at this combination in the frontline setting. And of course, there is data on other bispecific molecules that incorporate VEGF in the subsequent-line setting, particularly a combination that includes the VEGF/PD-1 bispecific antibody ivonescimab that's being studied in the HARMONi-A trial for patients with EGFR-mutated advanced non–small cell lung cancer, for which we hope to get some more definitive data in the coming months.
Brittany Harvey: Definitely.
And then you've just mentioned a few ongoing trials where we're looking for evidence to inform future updates. But thinking beyond that, into the future, what is the panel examining for future updates to this living guideline?
Dr. Joshua Reuss: It's a very exciting time to be in the world of treating advanced non–small cell lung cancer, particularly patients with driver alterations, because there is so much evolving data that's changing our practice in real time, again highlighting the importance of these living guideline updates. I'd say there's many things that we're excited to see. You know, a lot of the combination regimens in EGFR-mutated non–small cell lung cancer for which there are approvals and current recommendations in our guideline, particularly osimertinib plus chemotherapy and amivantamab plus lazertinib - those are the two approved combination strategies in the front line - we are now seeing the emergence of overall survival data for those combinations. So obviously that is something that's going to be very important for the committee to review and incorporate into guideline updates.
There are several new therapies coming down the road for other driver populations. We recently saw an approval for taletrectinib for ROS1 fusion–positive non–small cell lung cancer, so it's going to be important that the committee reviews the data and the publications regarding that therapy.
And then there are other novel therapies that we're looking to see updated data on. There are multiple antibody-drug conjugates, which take the potent power of a chemotherapy molecule and attempt to make that targeted with an antibody targeting to a unique feature on the cancer cell. And there are several antibody-drug conjugates that are in development at various levels of promise in this space, particularly in EGFR-mutated non–small cell lung cancer, and I anticipate seeing some emerging data for that coming up in the near future as well. So really, lots to be excited in the space and lots for our committee to review to give guidance on so that these patients can really receive the top-level care wherever they are being treated in the country and throughout the world.
Brittany Harvey: Yes, we'll await this new data to continue to provide optimal options for patients with stage IV non–small cell lung cancer with driver alterations.
So, Dr. Reuss, I want to thank you so much for your work to rapidly and continuously update and review the evidence for this guideline and thank you for your time today.
Dr. Joshua Reuss: Thank you so much.
Brittany Harvey: And finally, thank you to all of our listeners for tuning in to the ASCO Guidelines Podcast. To read the full guideline, go to www.asco.org/thoracic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, which is available on the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.
The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.
Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Therapy for Stage IV NSCLC Without Driver Alterations: ASCO Living Guideline Update 2025.1 Part 1
Dr. Lyudmila Bazhenova is back on the podcast to discuss the latest update of the living guideline on therapy for stage IV NSCLC without driver alterations. She shares the studies the Expert Panel reviewed in the first- and second-line settings, including NIPPON, HARMONi-2, and DUBLIN-3. Although these studies do not impact the existing guideline recommendations, Dr. Bazhenova provides context and comments on ongoing trials that will influence the next iteration of the living guideline.
Read the full living guideline update “Therapy for Stage IV Non-Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2025.1” at www.asco.org/thoracic-cancer-guidelines
TRANSCRIPT
This guideline, clinical tools, and resources are available at www.asco.org/thoracic-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-25-01062
Brittany Harvey: Hello, and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts.
My name is Brittany Harvey, and today I'm interviewing Dr. Lyudmila Bazhenova from University of California San Diego Moores Cancer Center, co-chair on "Therapy for Stage IV Non–Small Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2025.1."
It's great to have you back on the show today, Dr Bazhenova.
Dr. Lyudmila Bazhenova: It's my pleasure to be here.
Brittany Harvey: And then before we discuss this guideline update, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO conflict of interest policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Bazhenova, who has joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes.
So then to dive into the content here, Dr. Bazhenova, this living clinical practice guideline for systemic therapy for patients with stage IV non–small cell lung cancer without driver alterations is updated on an ongoing continuous basis. So what prompted this latest update to the recommendations?
Dr. Lyudmila Bazhenova: Living ASCO guidelines are designed to keep pace with rapidly evolving evidence that impacts treatment of our patients with lung cancer. As a committee, we are tasked with regular review of the published literature and determine if the new data warrants changes to existing recommendations. So in this recently published update, we evaluated new trials related to treatment of patients with metastatic lung cancer without driver alterations.
Brittany Harvey: Excellent. Thank you for that explanation of the process.
So, you just mentioned that the panel reviewed new trials for this update. So, which particular updated evidence did the panel review on first-line treatment options for patients with good performance status across histology and PD-L1 expression status, and how did this impact the recommendations?
Dr. Lyudmila Bazhenova: For the first-line treatment option for patients without driver alterations, two studies met our criteria for review. One was the NIPPON trial from Japan, the second was the HARMONi trial. None of those two trials resulted in change in our guidelines, but I think they are giving us some additional information that would be useful for the way we treat patients with non–small cell lung cancer without driver alterations. For example, if we take those patients, we currently have several treatment options as a first line. One is monotherapy immunotherapy. You can give pembrolizumab as an example, and that was based on the KEYNOTE-024 and KEYNOTE-042 trials. Then we have a platinum doublet plus immunotherapy, and there are several trials that did that pathway. And then we have also an option of giving our patients dual IO immunotherapy combination, such as CheckMate 9LA and POSEIDON.
At this point, we do not have any randomized trials comparing those three treatment modalities head-to-head. And the NIPPON trial was interesting to us because it was the first trial to compare CheckMate 9LA regimen, which is again, dual immunotherapy plus chemo, versus KEYNOTE-189 or KEYNOTE-407, which is a chemotherapy plus immunotherapy. And as a result of the study, while chemotherapy plus ipilimumab-nivolumab led to numerically higher overall survival, the difference was not statistically significant. And what is concerning in that trial is that we saw a higher number of treatment-related death occurring in nivolumab and ipilimumab arm compared to the pembrolizumab-chemotherapy arm. As a matter of fact, the trial was terminated early because of the increased risk of death. If you look at the treatment-related death in CheckMate 9LA, the 9LA study reported the treatment-related death to be 2%, and then in the NIPPON trial, the treatment-related death was 7%. Why is that happening? It's really difficult to say. The study was done in Japan. Maybe there is some pharmacogenomic differences between global population and Japan population. But certainly the higher rate of adverse events needs to be taken into account.
Another interesting thing about this trial is that it did not show any differences in a subset analysis for patients with squamous histology as well as PD-L1 negative tumor. So while this does not change our current guidelines and CheckMate 9LA treatment still remains an appropriate treatment option, it kind of raises the possibility that this combination could be associated with a higher toxicity. And we do have a randomized US-based trial that is ongoing, and we are hoping that eventually we will be able to answer that question after the trial will be completed.
The second trial we reviewed is HARMONi-2. So HARMONi-2 was a randomized, double-blind study which is conducted primarily in China, looking at bispecific PD-L1 and VEGF antibody called ivonescimab. And that took patients who were PD-L1 positive, as defined as more than 1% expression, and patients were randomized to pembrolizumab versus bispecific ivonescimab. And the study was positive. It showed improvement in median progression-free survival of 11 months versus almost 6 months in bispecific versus pembrolizumab. There were, however, higher grade 3 events in the ivonescimab arm. At this point, we are not changing our recommendations because this trial was done in an ex-US population, and we are awaiting a similar trial ongoing in the United States before we change recommendations and decide if ivonescimab needs to be included in our guidelines.
Brittany Harvey: This context is very helpful when clinicians think through the data behind these options. And it's important that the panel reviews this evidence, even if it doesn't prompt a change to the recommendations. And we'll await results of those trials that you mentioned to further inform this guideline.
So then beyond those studies for first line, what updated evidence did the panel review for second-line and subsequent treatment options for patients with good performance status, and how did this impact the recommendations?
Dr. Lyudmila Bazhenova: So for second line, only one trial met the criteria, and that was DUBLIN-3. DUBLIN-3 is a phase 3 single-blind randomized trial comparing docetaxel versus docetaxel plus plinabulin. And the study enrolled patients with second or third line. They have to have had platinum-based chemotherapy and progressed. Plinabulin is an interesting compound. It's a small molecule tubulin binder that prevents polymerization of tubulin and appears to impact dendritic cell maturation and T-cell activation. This study enrolled 559 patients, randomly assigned them to two groups. And one important information about this study is that was a study that was envisioned before immunotherapy became a standard mainstream treatment for first-line therapy. And only 20% of patients had prior PD-1 exposure. So therefore, the results of that study need to be taken into context of this population no longer existing in the United States because we use PD-L1 inhibitors in the first line.
And we saw that interesting in the plinabulin arm had lower rates of neutropenia but higher rates of serious adverse events. And at this point, we are not changing our guidelines for mainly two reasons. Number one, low number of patients that received prior treatment with first-line immune checkpoint inhibitors, as well as a modest overall survival benefit of this trial.
Brittany Harvey: Understood. I appreciate you describing that study as well and why that evidence didn't prompt a change to those particular recommendations.
So then, what should clinicians know as they implement this living guideline, and how does this new evidence impact clinicians and patients?
Dr. Lyudmila Bazhenova: At this point, none of the studies that we reviewed resulted in a change in guidelines. We are still waiting for more global results from some of the studies that I highlighted. It shows that there's still a lot of questions we need to be answering in those patients. And I'm hoping that with future clinical trials, we will be able to definitively maybe recommend one treatment over another. But at this point, all the treatments that I mentioned before remain appropriate for patients with stage IV non–small cell lung cancer without driver alterations.
Brittany Harvey: Definitely. And then you just mentioned that there's still a lot of outstanding questions in this field. You've mentioned a couple different studies where we're awaiting evidence. Beyond those that you already mentioned, what is the panel examining for future updates to this living guideline?
Dr. Lyudmila Bazhenova: Right now, our next task is to come up with a full guidelines update. ASCO have certain rules for the guidelines committee members. And so we are gearing for a full guideline update, which hopefully will be ready by the end of 2025.
Brittany Harvey: Excellent. We'll look forward to that full update of the living guideline, and we'll still await results of these ongoing trials to further inform this living guideline.
So I want to thank you so much for your work to rapidly and continuously update this living guideline, and thank you for the time today, Dr. Bazhenova.
Dr. Lyudmila Bazhenova: My pleasure.
Brittany Harvey: And finally, thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/thoracic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, which is available in the Apple App Store or the Google Play Store.
If you've enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.
The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.
Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Medically Integrated Dispensing Pharmacy: ASCO-NCODA Standards Update
Dr. Luis Raez and Michael Reff share the newest update to the medically integrated dispensing pharmacy standards from NCODA and ASCO. They review updates to domain one, on key patient-centered quality standards on health equity and social determinants of health, drug access, patient safety, education, and adherence to maximize treatment outcomes and domain two, on key operational quality standards on logistics, care coordination, and waste prevention. We also cover the impact of these updated standards for clinicians, oncology practices, and people receiving oral anti-cancer medications.
Read the complete standards, “Medically Integrated Dispensing Pharmacy: ASCO-NCODA Standards.”
Transcript
These standards, clinical tools, and resources are available on ASCO.org. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the JCO Oncology Practice.
Brittany Harvey: Hello, and welcome to the ASCO Guidelines podcast, one of ASCO’s podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts. My name is Brittany Harvey, and today I'm interviewing Michael Reff from the Network of Collaborative Oncology Development and Advancement and Dr. Luis Raez from Memorial Cancer Institute and Florida Atlantic University, co-chairs on "Medically Integrated Dispensing Pharmacy: American Society of Clinical Oncology – Network of Collaborative Oncology Development and Advancement Association Standards Update." Thank you for being here, Michael and Dr. Raez.
Dr. Luis Raez: Thanks for inviting us.
Michael Reff: Thank you for having us.
Brittany Harvey: Then, before we discuss these standards, I'd like to note that ASCO takes great care in the development of its standards and ensuring that the ASCO Conflict of Interest policy is followed for each guidance product. The disclosures of potential conflicts of interest for the expert panel, including Michael and Dr. Luis Raez who have joined us here today, are available online with the publication of the standards in JCO Oncology Practice, which is linked in the show notes.
So then, to dive into the content here, Michael, I'd like to start with what prompted an update to these ASCO-NCODA standards and what is the scope of this update?
Michael Reff: Thank you, Brittany. What led NCODA and ASCO to endeavor in this, and it started back in 2019 as the amount of oral anticancer medications became more and more prevalent in cancer treatment, we saw the need providing a blueprint for excellence in care for patients prescribed oral anticancer medications, specifically in the outpatient setting. And the update was driven by the rapid growth of these oral oncolytics starting back in the mid to late 2015 through 2019 or so, and then continued on into the 2020s where we are today. We saw the increase in the complexity of the management of these patients with these therapies basically outside the traditional clinical settings. And we wanted to make sure that with more cancer treatments that are taken at home than just at the clinic, like in the oral setting, new challenges had emerged around patient safety, access, adherence, and overall treatment success. The updates now address patient-centered and operational interventions designed to improve access, safety, quality, accountability, and outcomes of oral anticancer and other supportive care medications prescribed for the cancer patient.
Dr. Luis Raez: As Mike said, these guidelines help improve patient care tremendously, but also help us a lot as an oncologist, you know, community oncologists that- now that we have opportunity to dispense these oral oncolytics, we need help to create our medical integrated pharmacies, and NCODA is providing here a way that, how to do this safely, efficaciously, good quality, you know? So that's why I think we always do everything for the patients, but also this helps a lot to the doctors. And there are a lot of what we call specialty pharmacies or medical integrated pharmacies now nationwide.
Michael Reff: I'll build on what Dr. Raez had mentioned. This is the impetus. If you looked at the innovation that was coming from the pharmaceutical companies, many of it coming in the oral form for anticancer medications, and based on that, taking a look at the infrastructure that is in place in these practices, whether it's in the community or the IDN or health system settings, this amount of innovation that was coming needed to be addressed by taking a look at the medically integrated oncology team. And these standards address not just the pharmacy component, but also the whole continuum of care, starting with a medical oncologist or the hematologist, with the pharmacists, nurses, the pharmacy technicians, others that are involved in the care of the patient. And there were no standards involved. And when we approached ASCO back in 2018 to eventually publish the first version of these standards, the need was identified, and we worked collaboratively with ASCO to create the first set and then the revisions as we talked about.
One thing to note regarding the revision plus the original standards, we had a cross-section of the care team on the committee, and we did that very purposefully. So, the ASCO-NCODA team curated a committee to help develop these original standards and the revision of these standards with medical oncologists both from community and health systems, pharmacists from both community and health systems, and also nurses. And we also included a patient that currently has and currently receives oral anticancer medication. And so NCODA and ASCO are very proud of the committee that we put together because of the experts in their field, but also extended the invitation to a current patient. And we embedded everybody's expertise in the curation of these standards.
Brittany Harvey: Absolutely. I appreciate that background and context and how it's critical to improve patient care. And these standards really help oncologists, and we're looking across the continuum of care to provide optimal care for our patients.
So then next, Dr. Raez, I'd like to review the key points of the revised standards for our listeners. So for Domain 1, what are the key patient-centered quality standards on health equity and social determinants of health, drug access, patient safety, education, and adherence to maximize treatment outcomes?
Dr. Luis Raez: Yeah, this was a great effort, you know, at the multidisciplinary team. And as you can read in the standard, there were more than 240 publications reviewed; more than 55 of them are quoted here. And the standards are in two groups, as you said. With the group one, I'll briefly mention some of them. For example, SDOH, social determinants of health, is very important because as doctors, we prescribe, and sometimes patients don't get the medication, you know? And we prescribe assuming that 100% of the patients will get the medication. But something simple like the patient doesn't have insurance, the patient is underinsured. I have a patient that we didn't have an address to send the medication because he's homeless. Something that as a doctor you say, "Oh, oh my God, this is outside my realm," but it's not outside reality. So that's why, even if we don't think that this is part of our expertise dealing with social determinants of health, the fact that the patients have food insecurity, they don't have transportation, they don't have insurance, they don't have a caregiver, impact tremendously in the outcomes of the therapy. So that's why, basically, in this standard, we want to call attention that SDOH, social determinants of health, needs to be identified.
There are in the literature countless examples of why this is important. For example, in the guidelines, we quote two or three examples of prostate cancer studies that, for example, we quote a study of 27,000 people with prostate cancer that were taking oral oncolytics, and how come the fact that the elderly, seniors, the fact that they have high prescription costs, and how all of this affected the adherence to the medication. And that's why it's important to identify the SDOH. And in other sections of the guidelines, we said how to address them, no?
Another important thing in this domain is the cultural, you know, we need to be culturally sensitive and to take care of all of these social factors. For example, here in South Florida, we deal with the Haitian culture, Filipino culture, Latin culture, and American culture, and it's a blend, but it's not easy to go from one to the other.
Another one is the fact that we have to include new technologies. A lot of patients, for example, we use EMR, EMR Epic, and now Epic has everything in the phone. The fact that we can have now the patient can see her prescription medication over the phone, the fact that they can use the phone to request from you a refill, and from your phone, you send the refill to the pharmacy, and you notify from your phone to the patient that the refill is sent, and the patient can check in his phone that the refill is ready. These things are amazing because that's why it's important that we incorporate these technologies to the patient care, and in this specific case, of dispensation of oral therapies, no?
Another crucial point is education. You cannot be sending a patient a package of 300 pills without education. So that's why in our guidelines, mainly pharmacy, clinical pharmacies, or in some centers like mine, we have advanced practice providers, it's mandatory in our centers to have like a one hour of education before you send the prescription. So the patient is aware about side effects and contraindications, all of these things. They provide them also materials and also consent. You know, in the old times, you don't give chemo without a consent. Now, a lot of people say, "Oh, it's only a pill." There is a lot of benefits or side effects that can come from the pill, so you need to consent everybody, you know?
So, another aspect is adherence. I already told about that, but we need to provide patients with a baseline assessment, no? So, you cannot send again the prescription and hope, "Oh, I'll figure it out what happened next month when the patient comes back." I tell you, the patient is homeless, where are you going to send it? If the patient is telling you, "I don't have insurance," what good is it for you to send a prescription? The patient will not get it. So that's why you need to do a baseline assessment of adherence. You need to do a calendar. You need to do electronic support, I mentioned already with the EMR and the phones. For example, my MIP, my specialty pharmacist, sends me a message in the EMR, "Dr. Raez, the insurance is not covering, the patient has a high copayment, we are going to delay the dispensation of the medication." So there needs to be a communication. Or sometimes there is a confusion with the insurance, and I cannot wait for the poor patient to call three, four weeks later, "Oh, I didn't get the medication," to know what happened, no? My MIP is very good. They send the clinical pharmacist a message, "Hey, you know, the insurance doesn't believe that the pill is adequate, or you need to provide more documentation. You need to prove the mutation, the genetic aberration." So if you provide us that, the insurance may approve. So that communication with the doctor is very important to improve adherence.
And one important thing that we have in this one that we didn't have in the anterior is the tracking of outside medications. A lot of times you say, "Okay, the insurance allowed us to provide the medication it’s 100% responsible." But then the insurance says, "Oh, no, no, don't worry. CVS will provide the medication." So it says, "Well, it's you know, it's not my responsibility. CVS will provide the medication, they have to take care." But we know that outside our specialty pharmacies or MIPs, the care is not very good. So that's why we are taking our ownership that, "Okay, the insurance said the patient will get the medication from some outside pharmacy." But our clinical pharmacists track that. What happened? Did the patient get it? The patient didn't get it. The copayment is still high. So even if you get the medication from somewhere else, if the copayment is high, we, our clinical pharmacists, help the patient to navigate and get the foundation or the copayment or finally the maker, the industry partner, provides the drug for free, but somebody needs to do the paperwork. And that's why this is very important. We cannot abort our responsibility because, "Oh, the insurance said somebody else will give it." I work for the public healthcare system, so my patients, some of them don't have insurance, they are underinsured. So we see these problems every day.
And finally, the standards talk about the importance of safety, documentation, verification, monitoring, refills, you know, you need to keep track of refills. We already mentioned how important is the technology to facilitate the refills, and the quality.
Brittany Harvey: Yes, thank you for touching on those highlights for Domain 1. It's important that all patients have access to care and these oral anticancer medications, and not only just access to care, but safe and effective care. It's really important, as you mentioned, Dr. Raez, to meet patients where they're at and incorporate technology. And I also want to note the coordination with external pharmacies that you mentioned in tracking outside medications as well. It's not only important for multidisciplinary care within the oncology practice itself, but also external to the oncology practice. That's why we put together this multidisciplinary panel to develop these standards.
So then, expanding on that, Dr. Raez, for Domain 2, what are the key operational quality standards? Those on logistics, care coordination, and waste prevention.
Dr. Luis Raez: Yeah, we have a lot of standards here, but maybe we can summarize in five or six points, no? For example, financial toxicity in cost and waste are very important because the patients, yeah, you put them on therapy, but as you can understand, if there is disease progression, the patient don't need the medications. And sometimes you get refills even if the patient has disease progression. If you do a dose reduction, the same problem. Or you discontinue medication and the patient keeps getting the drugs. So, you're talking about drugs that are between 20 and 30 thousand dollars per month. This is a lot of money. There are studies that we're quoting in the standards that the waste could be from 1 to 3 or 4 thousand per patient, no?
Another aspect is dispensing. When you dispense the medication, this is not as easy as, "I'll ship to your house a bag of medications." You know, there needs to be a diagram, a decision tree. You need to train the staff to know what we're doing. There needs to be an auditing of the process. They need to be even packaging and shipping, you know? For example, I'm in Florida today and outside in summer it's going to be 95 degrees. So, everybody leaves the package outside your house, and sometimes you go the whole day until when you come at 6:00 p.m. There are medications that cannot be left outside there, you know? I don't know, it sounds like a joke, but I have a patient that the medication used to be stolen because people thought that that was something important, you know? And of course, it's important because it's a $20,000 medication. So, the poor patient, because he lives in an area that is not safe, has to come and pick up in person. All of these things sound very trivial, but that's real life that affects adherence.
Another important thing is shortage. This is something that we just suffered two or three years ago, and we have to think about what happens in the next shortage. What happens if there's going to be a shortage? What do we do or how are we going to do that? Now we know it's something that is happening probably very soon again, and something that we have to consider.
Another standard is the care coordination. You need to have probably, if it's possible, a coordinator. I know that for small practices it's very hard, but for big cancer centers, you should have a coordinator of this. I already mentioned before, the communication between the physicians and the doctors to coordinate the care, no? You need to write the prescription again, you need to provide more information, or to be notified, "Hey, you know, the patient is throwing up in the first week, you need to see the patient, please," no? So, this type of communication needs to exist so we can serve the patient better.
It's also important, you know, we're improving quality and we're improving care. It's important to try to collect patient-reported outcomes. This is something that now we have the opportunity, if we do things well, to do it and show that we're providing a better care. The other thing is that we already mentioned SDOH in the other standard. In this standard, we mention mainly SDOH to partner. For example, we collect in my center SDOH, and I always get frustrated when the patient doesn't have transportation. But I didn't know that there are local institutions that provide free Uber rides, free Lyft rides. So that's why it's important to partner with these institutions. I have a local grocery chain that provides free food for the patients, and I didn't know that. It's important to be aware what the patient needs and what resources do you have to fulfill the SDOH. That's the part that we mention in here. So that's why, in summary, those are the six probably most important points here. I'll ask Mike for some comments.
Michael Reff: Thank you, Dr. Raez. Brittany, to answer your question, and as was pointed out on logistics, care coordination, and prevention of waste, certainly that is an aspect that has changed in the revision that we're here to talk about. There's really two components to waste, and it's cost avoidance and then waste prevention. And as Dr. Raez mentioned several times, the importance of the medically integrated team and having the ability for that practice to fill that prescription internally and have robust documentation. Cost avoidance is a critical component that the medically integrated pharmacy, or the MIP, can help the total cost of care. And that is by preventing errant fills or waste that can occur by intervening in the care of the cancer patient, as we do every day. But when the practice has access to the medication and can fill that prescription in-house in the medically integrated pharmacy, that team, that care coordination that takes place, can prevent those errant fills or additional fills when there's dose reductions, there's holidays, there's things that happen in real time. And it's impossible for a mail-order pharmacy that's in another state that has lead times, when a prescription needs to be mailed 7 days or 10 days before the patient will run out of the medication, it's impossible for them to logistically coordinate that care like we can internally within the medically integrated pharmacy.
So, we prevent waste and overall cost of care by cost avoidance and having that coordination or that continuity of care that we talk about. And we prevent waste from the mail-order pharmacies by taking that prescription internally and filling it, but also doing it in a way that's more sustainable and cost-effective for all stakeholders in the oncology ecosystem.
Brittany Harvey: Absolutely. Thank you both for reviewing those key standards for Domain 2 and touching on the importance of distribution logistics and all the things that a medically integrated pharmacy needs to think through in getting oral anticancer agents to patients.
Following that, Michael, we've touched on this a little bit earlier, but how will these updated standards impact clinicians and oncology practices?
Michael Reff: Yes, and as Dr. Raez and I have discussed throughout this podcast, these additional standards are there to help support that continuity of care by educating the clinicians that are in the oral anticancer medication space to elevate their provision for these oral therapies. What I mean by that is the practice has to perform at a certain level in order for them to, as I call it, deserve the right to fill that prescription by having the processes and procedures in place. And these standards, these updated or revised standards, are the blueprint for better patient care and to help the practices execute on that journey of continuous improvement.
Dr. Luis Raez: Yeah, I only want to add, we have practical examples in the guidelines. We quote a couple of studies that have been successful. And this year, for example, I am a lung cancer doctor, we are presenting in World Lung our standards of adherence to oral oncolytics for EGFR therapy, following the NCODA-ASCO standards. We're around 95% of adherence. We are a healthcare system that is public. We have people with no insurance and a lot of social determinants of health. We are trying to show that it's feasible, even in the most difficult circumstance, when you follow the standards, to be successful.
Brittany Harvey: Definitely, these standards can help clinicians and oncology practices succeed in providing these medications.
So then beyond that, and to wrap us up, Michael, what do these revised standards mean for patients who are receiving oral anticancer medications?
Michael Reff: Yes, great point and question, Brittany, because we have covered the benefits to the clinicians and the practices themselves. But how is this going to support better patient care? And it does it in a whole host of ways. I'll cover just a few of them. What I'm about to share with you relates back to what we call at NCODA the "core claims." Like, what's the core claims of having a medically integrated pharmacy within the practice? And there are seven different core claims that we feel practices that are focused on the continuity of care can deliver better outcomes that are embedded in these standards. And it's talking about abandonment, adherence, access and affordability, speed to therapy or time to fill, as we call it, education, patient satisfaction, and cost avoidance that we covered earlier. So those are the core claims that a practice that follows these revised standards can help elevate.
So, faster and more affordable access to the oral cancer medications; individualized support to address barriers like transportation, finance, language, or health literacy, and so on; clear, patient-friendly education; something that is near and dear to all clinicians' hearts, and of course, the patient that was on our panel or on our committee, to empower them to manage side effects and recognize when to seek help; and a stronger partnership with a care team, with regular follow-ups focused on their experience, challenges, and successes; and then, greater overall safety through proactive monitoring for medication errors or complications. So all of these aspects, or tenets, as I'll call them, are baked into these quality standards that are totally aligned with NCODA's core claims document that, again, talks about abandonment, adherence, access and affordability, speed to therapy, education, satisfaction for the patients, and also cost avoidance.
Dr. Luis Raez: I only want to add and invite the community to adhere to these standards, to practice the standards. You will be providing the best patient care that we can nowadays.
Brittany Harvey: Definitely. I think these standards are very important. And Michael, I thank you for touching on those key claims from NCODA. I think those, along with these updated standards, will improve outcomes for patients everywhere.
So I want to thank you both so much for your work to update these standards and all the time you put into it. And thank you for your time today too, Michael and Dr. Raez.
Michael Reff: I'd like to thank not only the committee, my esteemed committee that helped support the standards and the revision. Many of the original healthcare providers and patient that were on the first go of the standards were part of the second standards. We revised it, of course, and we got additional support from the new committee. And certainly ASCO and their partnership and collaboration with NCODA has been tremendous. And we look forward to the oncology community at large adopting these standards, again, to work together, we do become stronger, and it will improve cancer care for patients receiving oral anticancer medications. So thank you, Brittany.
Dr. Luis Raez: I only want to say the same thing. Actually, there is probably more people in NCODA that is not in the publication that has helped. Same in ASCO. Also, we want to give thanks to Dr. Stephen Grubbs, our leader in quality. He's retiring. We're going to miss him, but he has been a key collaborator with Mike organizing these standards for the last five or six years. So, looking forward to these standards in practice.
Brittany Harvey: Absolutely. A big thank you to the entire panel and everyone who contributed to this, and NCODA as well.
And then finally, thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the complete standards, go to www.asco.org/standards. I also encourage you to check out the companion episode on these standards on the PQI podcast by NCODA, which you can find on Apple Podcasts and Spotify. You can also find many of our standards and interactive resources in the free ASCO Guidelines app, which is available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.
The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.
Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Symptom Management for Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors Guideline
Dr. Kimberly Perez and Dr. Jaydira Del Rivero discuss the new guideline from ASCO on symptom management for well-differentiated GEP-NETs. They share the latest recommendations on managing symptoms related to hormone excess, including carcinoid syndrome and carcinoid heart disease, managing symptoms of functioning pancreatic neuroendocrine tumors, and also palliative interventions. Dr. Perez and Del Rivero share how to use this guideline in concert with the systemic therapy for tumor control in metastatic well-differentiated GEP-NETs guideline, and hope for the future for the treatment of gastroenteropancreatic neuroendocrine tumors.
Read the full guideline, “Symptom Management for Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors: ASCO Guideline.”
Transcript
This guideline, clinical tools, and resources are available on ASCO.org. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in JCO Oncology Practice.
Brittany Harvey: Hello and welcome to the ASCO Guidelines Podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges, and advances in oncology. You can find all the shows, including this one, at asco.org/podcasts.
My name is Brittany Harvey and today I'm interviewing Dr. Kim Perez from Dana-Farber Cancer Institute and Dr. Jaydira Del Rivero from the Center for Cancer Research at the National Cancer Institute, co-chairs on “Symptom Management for Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors: ASCO Guideline.”
Thank you for being here today, Dr. Del Rivero and Dr. Perez.
Dr. Kim Perez: Thank you.
Dr. Jaydira Del Rivero: Thank you so much for the invitation.
Brittany Harvey: And then before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest Policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Perez and Dr. Del Rivero, who have joined us here today, are available online with the publication of the guideline in JCO Oncology Practice, which is linked in the show notes.
So then to jump into the content here, first Dr. Del Rivero, could you provide an overview of the scope and purpose of this guideline?
Dr. Jaydira Del Rivero: Yeah. Thank you so much. Well, first, we really wanted to thank ASCO for allowing us to develop these guidelines for the management of gastroenteropancreatic neuroendocrine tumors. I do want to mention that there is also another set of guidelines that I was very fortunate also to co-chair with Dr. Perez on the systemic management of gastroenteropancreatic neuroendocrine tumors. But when discussing these guidelines as well as with the different panelists, experts in this type of disease, we also realized that the management of these tumors are quite complex, not only from the management of the disease progression, but at the same time, management of the symptoms related to the hormone excess. And because of that, we like to thank ASCO for allowing us to then not only have a discussion on the systemic management of these tumors, but at the same time develop recommendations for the symptoms related to the different hormones that these neuroendocrine tumors may produce.
These guidelines are for the management of grade 1 to grade 3 metastatic gastroenteropancreatic neuroendocrine tumors. These guidelines include the management of the different aspects and the symptoms related to hormone excess, such as carcinoid syndrome, carcinoid heart disease, how to manage carcinoid crisis, as well as the different symptoms and how to manage the functional pancreatic neuroendocrine tumors and as well as provide recommendations in the different treatments for these tumor types, not only from the systemic management but also from the surgical management as well as for liver-directed therapy options and the different aspects in terms of the palliative care of these patients to improve not only the symptoms related to the hormone excess caused by these tumors, but as well as to improve the quality of life.
Brittany Harvey: Absolutely. And I appreciate that overview. And yes, we'll link the guideline on the Systemic Therapy for Tumor Control for Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors in the show notes for our listeners so that they can refer to that companion guideline as well.
So then you just described the several different categories of recommendations that this guideline covers on symptom management. So, Dr. Perez, I'd like to start reviewing some of those key recommendations of that guideline. So, starting with what are the key recommendations for carcinoid syndrome and carcinoid heart disease?
Dr. Kim Perez: Thank you Brittany. Yeah, I also want to thank ASCO for inviting us to do this podcast today. Just to start, I think these guidelines will really add to what's available in the literature to provide a kind of a quick look for the community provider to manage carcinoid-related symptoms. I think the highlights that I would point out are we've all been using somatostatin analogs for the last few decades to manage symptoms, but with the newer treatments that are now available, we tried to highlight what does the literature support in regards to PRRT, what does the literature support in regards to using systemic therapy for disease management, but also the benefits that you will get from a symptom management perspective using other modalities. I think the highlight really is it's a multidisciplinary approach. We are now considering surgery and embolization or interventional radiology as a critical piece.
And I think the third that I'd highlight is the fact that sometimes we get too focused on carcinoid syndrome and the symptoms will actually, may result from other things. And the highlight in the algorithms that we've provided is what other things cause carcinoid-related diarrhea. And let's not forget about that because we will find ourselves treating and patients getting very frustrated with persistence of symptoms when in actuality, we should be treating something else that is causing a very similar symptom.
For carcinoid heart disease, I think there are more and more guidelines that are now available to provide guidance there, but I think the major advances are that we should be utilizing heart assessment with echocardiogram with lab values such as BMP. But also critical to this is consulting with our cardiology colleagues and making sure that we're identifying heart related issues that are resulting from hormone excess sooner than later because interventions on the earlier side can really make a significant impact on quality of life and associated comorbidities and mortality.
Brittany Harvey: Thank you for reviewing those key points for both carcinoid syndrome and carcinoid heart disease symptom management.
So then the next set of recommendations. Dr. Del Rivero, what are the key highlights for symptom management of functioning pancreatic neuroendocrine tumors?
Dr. Jaydira Del Rivero: Yes, it's very important to recognize the symptoms related to hormone excess due to pancreas neuroendocrine tumors. Up to 10% of pancreas neuroendocrine tumors may produce different hormones. Among those hormones can be insulin, gastrin, glucagon, somatostatin. So it's important to know and understand that based on what a neuroendocrine tumor is, they may produce different types of hormones. The importance of these guidelines is to also recognize some of these symptoms and how to address that, because it's not necessarily in these tumor types besides the management of metastatic disease, and know the different options that we recommend for metastatic disease from the systemic therapy, such as chemotherapy or targeted therapies or PRRT. It's important to recognize the symptoms because based on the symptoms we may recommend a different approach. That's something that is important to acknowledge and recognize. Moreover, in certain functional pancreas neuroendocrine tumors, as Dr. Perez mentioned, is a multidisciplinary approach. And it's important to also discuss these different cases with your endocrinologist. You may need to have an experienced endocrinologist to manage, for example, the excess of insulin. And also discuss your cases with a surgeon and interventional radiologist because some of these approaches can certainly improve the symptoms related to hormone excess.
I understand that sometimes medical oncologists in the communities may not have access to the multidisciplinary approach or have the different teams that can manage these tumors, and that's the reason why with these guidelines we wanted to establish the understanding of different symptoms associated with the hormone excess to these neuroendocrine tumors as well as how to manage this. For example, in the case of insulinoma, I think for the medical oncologist it is important to know that the everolimus is an option to be used for these tumors, not only to manage tumor progressions related to this tumor type at the same time, because everolimus as a side effect causes hyperglycemia, that can also improve some of the symptoms related to the excess of insulin besides the somatostatin agonist. I think these recommendations will allow the medical oncologist to recognize the symptoms and based on what the symptoms cause, then you can have a different approach that could be added to the systemic therapies options as well.
Brittany Harvey: Yes, beyond systemic therapy, it's important to be recognizing symptoms to provide an individualized approach for every single patient.
So then, following that overview of symptom management for functioning pancreatic neuroendocrine tumors, Dr. Perez, what is recommended regarding palliative interventions for patients with gastroenteropancreatic neuroendocrine tumors?
Dr. Kim Perez: Yeah, great question. So I think what's unique to neuroendocrine tumors is that the palliative approach really mirrors what we would be doing for symptom management. Some of these patients are living a very long time with carcinoid related symptoms. And so the approach that we take for the carcinoid symptom control is going to mirror the palliative piece of it. I think for those who develop a burden of disease related symptoms, I think it mirrors what we do across the board for all cancer-related complications. And so I think what we attempted to highlight here and included one of our colleagues who focuses specifically on the field of palliative care and neuroendocrine tumors, was to never really lose sight of what we've been doing to care for symptom management throughout the patient's journey and to always rereview the etiology of the symptoms, ensure that we don't focus solely on carcinoid-related issues, but also the symptom management that we would apply to all patients with cancer-related burden symptoms.
Brittany Harvey: Definitely. I think that's a helpful approach to consider when thinking about how to manage these palliative interventions as well.
So then Dr. Del Rivero, what should clinicians know as they implement these symptom management recommendations?
Dr. Jaydira Del Rivero: Yes, thank you so much for that question. As we have discussed in the last 10 or 15 minutes, we have discussed the different approaches on the management of gastroenteropancreatic neuroendocrine tumors. Clinicians, I think it's important to know that neuroendocrine tumors is a quite complex disease because we're not only addressing the management of tumor growth, but we're also addressing the management of the symptoms related to hormone excess and the complexity associated with that. When medical oncologists or clinicians implement these recommendations it’s to understand what symptoms these tumors may cause related to the hormone excess but at the same time, how do we approach those symptoms? As Dr. Perez said that I think is very important is to recognize the different types of diarrhea. It doesn't mean that if the patient has worsening diarrhea, it doesn't mean that this is related to disease progression. So it's important to recognize so that way you can address that, because the type of diarrheas can be related because of the lanreotide or somatostatin agonist, it could be because of the prior surgery. I think it's important to recognize those in order to address the symptom. And the same with the gastroenteropancreatic neuroendocrine tumors. It's important to know what hormones they produce because there are different measurements that may be added to the systemic management of these tumors.
I think that there are two aspects here, and that's the reason why these guidelines were implemented in the sense that not only we're going to manage disease progression of these tumors, or how do we manage the metastatic disease of these tumors, but at the same time, how do we manage the symptoms related to the hormone excess and the different complications. Moreover, I think, as we discussed earlier, we need to manage these tumors in a multidisciplinary approach. And something very important is not like one size fits all, because the treatment recommendations, it will depend on different characteristics in terms of the tumor presentations. And hormone excess is one of the important aspects to recognize so that way we can implement these recommendations that will definitely help the quality of life of these patients.
Brittany Harvey: Absolutely. And using these guidelines in concert with the systemic therapy guidelines is key.
And then beyond this impact for clinicians that Dr. Del Rivero has just outlined, Dr. Perez, what does this new guideline mean for patients with gastroenteropancreatic neuroendocrine tumors?
Dr. Kim Perez: Yeah, I think that's an important highlight of this guideline. It really gives patients a voice. I think it recognizes the fact that these symptoms can go unmanaged or mismanaged or just missed, and patients commonly will come in feeling very frustrated and feeling very ill. And I think it will provide them a means to open up a conversation with their providers and say, “Hey, this is what I'm experiencing. Let's talk about what's available. How does this apply to me?” And I think that can be very empowering. I think it's really hard nowadays with so many sources and resources online and patients are really left wondering what are the bullet points that they should be bringing to their clinician appointments? And I think that these guidelines provide them a good framework for those discussions.
Brittany Harvey: Yes, bringing these discussion points for patients is very important to be able to have those resources. And we have some patient resources and information available on the website for this guideline and we can link that in the show notes for listeners.
So then you've both touched on the importance of this guideline for improving quality of life and we continue to see advancements in this field. So Dr. Del Rivera, what are the outstanding questions regarding symptom management and tumor control for gastroenteropancreatic neuroendocrine tumors?
Dr. Jaydira Del Rivero: I have to say whenever somebody asks me that question, the word that I will say is I feel hopeful, because more than 10 years ago we didn't have that many options for gastroenteropancreatic neuroendocrine tumors. And it has been in the last decade or so that there has been more developments in the management of these tumors as well as the understanding of the symptoms related to these tumors. But that said, yes, we do need more therapies for gastroenteropancreatic neuroendocrine tumors. Of the treatment options that we have, we all know in the field that even though we have disease control by using the different options for the systemic management of gastroenteropancreatic neuroendocrine tumors, we need options where we can achieve an objective response, especially for these tumor types. But there is a significant volume of disease and we see a lot of these patients with gastroenteropancreatic neuroendocrine tumors. And now where the field is going is to make some of these therapies more effective, to develop more therapies as well. For example, immunotherapies, a different type of immunotherapy understand the tumor immune microenvironment of these tumors in order to develop therapies as well. From the antibody drug conjugates, I think that's a new way to also address or treat these tumor types, understanding about the different markers found on these tumors that way they can be addressed in different ways. Now with the development of new therapies, I think that's something that can help us as well not only have disease control and as well as having an objective response, but having a better objective response can certainly also help with the symptoms related to hormone excess too.
In terms of other therapies, I think some of the issues that we encounter are like the refractory carcinoid diarrhea and how do we manage this. We do have therapies that can help us control the diarrhea in the refractory settings, such as telotristat. Telotristat is one of the newer medications that can help us control the refractory diarrhea. But that said, despite this, that we still encounter situations where it's sometimes difficult to control. I think in those situations it will be good to understand more about the biology of these tumors as well and how we manage. If there is a different time or how do we implement these options. I think there is so much to learn. But that said, I feel we're in hopeful times. We're understanding more about these tumors so that way we can help us develop better therapies not only to have control of the tumor growth as well having control of the symptoms. And it's the same with the pancreas neuroendocrine tumors in the metastatic setting. Sometimes it may be difficult to control this hormone excess. But understanding these and having therapies that can achieve more of an objective response, I think that will definitely help us more and manage these patients.
But one aspect I want to mention, and Dr. Perez also mentioned as well, the fact that we have these guidelines that help us understand about the different symptoms related to hormone excess and how to address it, I think is very important because having symptoms related to hormone excess can be detrimental to the quality of life on patients with neuroendocrine tumors that may necessarily be related to disease progression and having this information is so important. And I'm hopeful for the different therapies. There's different clinical trials ongoing for neuroendocrine tumors and especially in the field of PRRT. And a lot of more information will come with the different alpha-PRRT and combination therapy. So more information to come in the next couple of years. So this is, in my opinion, hopeful times for this field.
Brittany Harvey: It's great to hear that you're hopeful for all the developments in this field and we'll look forward to the development and discovery of new therapies and further research and then, hopefully incorporate those updates into guidelines in the future.
So I want to thank you both so much for your work to develop these guidelines and thank you for your time today. Dr. Del Rivero and Dr. Perez.
Dr. Jaydira Del Rivero: Thank you so much for having us.
Dr. Kim Perez: Thank you.
Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/gastrointestinal-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, which is available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.
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