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ASCO CEO Meets ASCO CMO: Retiring ASCO Chief Medical Officer Dr. Richard L. Schilsky Gives Far-Reaching Interview on this AiA Podcast

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.

Sneak Preview: ASCO to Hold First-ever Virtual Congressional Advocacy Summit and Week of Action in 2020

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).

Get to Know Dr. Lori J. Pierce and Her Plans to Improve Equity in Cancer Care During Her ASCO Presidential Year

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 futureSo, 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.  

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 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

Therapy for Stage IV NSCLC With Driver Alterations: ASCO Living Guideline Update 2023.3 Part 2

Dr. Natash Leighl and Dr. Jyoti Patel are back on the podcast to discuss the update to the living guideline on stage IV NSCLC with driver alterations. This guideline includes recommendations for first-, second-, and subsequent-line therapy for patients with driver alterations including: EGFR, ALK, ROS1, BRAFV600E, MET exon skipping mutation, RET rearrangement, NTRK rearrangement, HER2, and KRAS G12C. They highlight the key changes to the recommendations, addition of recent trials, the importance of biomarker testing, and the impact of this guideline for clinicians and patients living with advanced NSCLC. Stay tuned for future updates to this continuously updated guideline.

Read the full update, “Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3” at www.asco.org/living-guidelines.

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/living-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.23.02744.   

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 am interviewing Dr. Jyoti Patel and Dr. Natasha Leighl, co-chairs on “Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2023.3.” Thank you for being here, Dr. Patel and Dr. Leighl. 

And before we discuss this guideline, I would 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. Patel and Dr. Leighl, who have 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 start us off on this living clinical practice guideline, Dr. Leighl, this guideline for systemic therapy for patients with stage four non-small cell lung cancer with driver alterations is being routinely updated. What new data was reviewed in this full update to the living guideline?

Dr. Natasha Leighl: Thanks so much, Brittany. So, we looked through the literature for publications between February and the end of October 2023, and also any novel agents that were approved, in particular by the United States FDA, to really incorporate this update in the current guidelines. In particular, we had updates in EGFR-driven tumors, BRAF and RET-driven tumors. And we also worked very hard to make this more digestible. In particular, it was turning into a bit of a laundry list of all of the things that we had ever recommended. So we really wanted to shorten things, pare them down, and really make them helpful and very, very current for the treatment of people with lung cancer in 2023 and 2024.

Brittany Harvey: Excellent. Thank you for providing that overview of the evidence reviewed and the key updates that we will address in this guideline. So then I would like to talk about some of those key updated recommendations from the expert panel. You mentioned both EGFR, BRAF, and RET. So starting with patients with stage IV non-small cell lung cancer with EGFR alterations, Dr. Leighl, what are the key changes to those recommendations?

Dr. Natasha Leighl: So, as I said, we really started to get quite a long list of things we recommended, including drugs that, to be honest, we no longer think are what we should lead with first-line. So we updated the recommendation to recommend first-line osimertinib in patients with sensitizing mutations. We were also able to capture in this update for patients with EGFR exon 20 insertion mutant lung cancer, the data from the randomized PAPILLON trial, recommending amivantamab plus chemotherapy for progression-free survival benefit. Not yet an overall survival benefit, but we will see how these data mature. 

The other thing that we did was we moved all of the- I don't want to call them "legacy agents" because, in many countries, these are still very important. But older agents such as gefitinib, approaches such as gefitinib plus chemotherapy, and drugs like dacomitinib and other agents where we truly believe as an international panel that we would prefer a third-generation kinase inhibitor like osimertinib. We moved all of those to our discussion, just to recognize that, around the world, not everybody may have access. And we also specified that things are different in different countries. So, for example, in China, there are other third-generation kinase inhibitors with randomized data to support their use. And those are approved and used in China. And also, for example, in Korea, there are other agents that are used. So, we have really tried to be both inclusive and yet keep things simple at the same time. And hopefully, we have succeeded. 

One of the challenges was that, with all of the updates that we made, we did not have all of the publications out yet at the end of October to make recommendations about moving beyond osimertinib in the first-line setting. So, please stay tuned for the next guideline update, where we’re going to tackle whether we should give osimertinib alone or combination therapy.

Brittany Harvey: Excellent. Thank you for providing those updates and clarifications for those patients with non-small cell lung cancer and an EGFR alteration. And we will look forward to the guideline panel's review of that evidence and future updates as well.

So then, Dr. Leighl, you had previously mentioned that additional recommendations were updated, such as those for patients with BRAF alterations and RET alterations. So, Dr. Patel, what are the other key updated recommendations from the expert panel?

Dr. Jyoti Patel: Thanks so much, Brittany. So certainly, I think we have seen many of these trials mature over time, which has been fantastic. I think one remarkable achievement was the reporting of a phase III selpercatinib trial. This was a trial in the front-line setting, in which patients who were RET-positive were randomized to selpercatinib versus carboplatin-based chemotherapy. And the selpercatinib significantly outperformed platinum-based chemotherapy, and I think really demonstrated a significant improvement in progression-free survival. So, based on that phase III trial, the recommendation for selpercatinib was elevated. Many of these agents that are used in clinical practice are approved initially on smaller phase I or phase II trials. And so, seeing the maturity of these phase III trials gives clinicians and patients greater certainty that these agents are really effective. And so, the evidence was increased for that, and that's now a preferred agent over another TKI, pralsetinib, in which there is only phase II data. So, certainly, those kinds of real things that we can explain to patients are important in these guidelines. 

Another thing that we were able to update was another doublet for BRAF V600E non-small cell lung cancer. So, the combination of the two TKIs, encorafenib and binimetinib, was also included in the guidelines. 

One thing that we tried to help was really identifying the best therapy post-progression on these first-generation TKIs. And again, there is a paucity of data, but often we went back to carboplatin-based doublets, and there is some data regarding whether or not patients with driver alterations should get immunotherapy in the second-line setting. And so, certainly, I think we have a number of randomized studies for patients with classical EGFR mutations, and our recommendation is generally avoidance of immunotherapy for these patients and treating many of these patients with carboplatin and pemetrexed when appropriate. I do not think we have the data for a lot of other subsets of patients. So, again, stay tuned as these data evolve.

Brittany Harvey: Thank you for reviewing those updated recommendations and the supporting evidence. I think it's helpful for our listeners to understand the level of evidence behind these recommendations as well. 

So then, Dr. Leighl, what should clinicians know as they implement these new and updated recommendations?

Dr. Natasha Leighl: It's really important, first of all, to make sure that you have the information that you need to get your patients to these great new treatments as part of the shared decision-making process. So your patients need biomarker testing. You need to get that as quickly as you can. As Dr. Patel has highlighted, you really want to get that before they start their first-line therapy, if at all possible. We also really tried to bring out in this guideline that when things are delayed, I mean, this is the real world that we live in, just to be very cautious of immunotherapy with chemotherapy for that first cycle. That obviously, again, is a discussion with your patient, but this concept that the approach of a cycle of chemotherapy while you wait for the next-generation sequencing testing. And then if the patient does not have a driver alteration, adding any other therapy as appropriate is okay. It's something that people do. We believe it's important as we talk about the balance between benefits and harms. And so I think that's in there for clinicians, and I hope that they and patients can really benefit from that to avoid toxicity and also to really improve the ability to get molecular testing results first line. 

Also, I think it's really important that when people read the wording of the guidelines, that this really follows GRADE, which is a type of system that we use to develop our recommendations. And so things like "may" do not mean that you shouldn't do it. So sometimes we'll hear back from clinicians and say, "Well, you said that they may use alectinib or lorlatinib, for example, with ALK, and I can only get coverage for one or the other." And so I think it's really important that clinicians and patients recognize that all of the things that we do recommend, even if we do use the word "may" or the recommendation is more conditional, we do think that these agents should be available for patients and clinicians, and that they go through this shared decision-making process together. 

And so I think that's something that clinicians, we hope, can help take forward as they advocate for their patients to get access to these different and new and emerging treatments that have clearly shown benefit. Even when we say patients and clinicians may use this or that, there may be excellent reasons for using something newer, that’s emerged, perhaps for toxicity benefits or benefits in terms of efficacy, even though we can't compare directly. And so we really want clinicians and patients to be empowered to access these new compounds and these new exciting agents that are in our guidelines.

Brittany Harvey: Absolutely. Thank you for reviewing those key points. And, yes, that's a great comment that the level of obligation in the recommendations may be based on the evidence quality, but that doesn't mean that clinicians and patients shouldn't have access to all of the recommended treatment options to offer patients based off their individual patient and clinical characteristics. 

So then, Dr. Patel, in your view, how will these changes affect patients with non-small cell lung cancer, with driver alterations? 

Dr. Jyoti Patel: A lot of this echoes the points made by Dr. Leighl. I think there are opportunities for patients to assess toxicity or what it means for intensification of therapy. So, particularly for EGFR patients, for example, we have data that chemotherapy with osimertinib can improve progression-free survival, or the incorporation of a bispecific antibody, amivantamab, can improve progression-free survival over the TKI alone. It certainly comes with increased toxicity. And so how we weigh this in the absence of a known survival benefit at this juncture is one that, again, really gives patients the opportunity to prioritize what's important for them. And so I think this guideline affects patients and that we have multiple options, we help with the weight of the evidence so they may be able to better discern what treatment makes sense for them.

Brittany Harvey: Understood. Yes, this guideline provides lots of options for different patients based off their driver alterations. So it's helpful to have that information for shared decision-making with their clinicians. 

So then finally, to wrap us up, Dr. Leighl, what current research is the living guideline expert panel monitoring for updates to the guideline recommendations?

Dr. Natasha Leighl: This process of the living guidelines has really been to help us stay on top of the amazing and incredibly rapid progress that we're making in lung cancer and other cancers. And even with this process, where we're trying to stay up-to-the-minute, there have already been some changes in the literature between the start of November and now. And so we're already working on some additional commentary and options for the first-line treatment of patients with EGFR-mutant lung cancer. Also, the subsequent treatment of patients with EGFR-mutant lung cancer, depending on what they've had before. Also, a great new study in patients with ROS1 fusion-driven lung cancer. And so these are some of the things that we're looking at.  

Also, a bit more discussion about the importance of molecular testing. In our companion article, the Journal of Oncology Practice, along with Dr. Patel, we're going to be talking a bit more about new ways to genotype, for example, using both liquid biopsy and tumor tissue at the same time, and some of the support for that and how it gets us with our patients to the answers that they need faster. 

Brittany Harvey: Absolutely. The pace of research in non-small cell lung cancer has moved quite quickly. So we definitely appreciate the panel's efforts to review all of this evidence on a continuous basis and take the time to develop these guideline recommendations for both clinicians and patients with non-small cell lung cancer. 

So I want to thank you so much for your work to update these guidelines, and thank you for your time today, Dr. Patel and Dr. Leighl.

Dr. Natasha Leighl: Thanks so much. It's a real pleasure to be here.

Dr. Jyoti Patel: 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/living-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, 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 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 2023.3 Part 1

Dr. Jyoti Patel and Dr. Natasha Leighl discuss the latest full update to the stage IV NSCLC without driver alterations living guideline. This guideline addresses first-, second-, and subsequent-line therapy for patients according to their histology (squamous cell and nonsquamous cell carcinomas) and PD-L1 expression. They discuss the streamlined recommendations, incorporation of recent evidence, and the highlights for implementation of these recommendations in the treatment of advanced non-small lung cancer. Dr. Patel and Dr. Leighl also point out ongoing trials that will inform this continuously updated guideline as we look ahead. 

Read the full update, “Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3” at www.asco.org/living-guidelines.

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/living-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.23.02746.   

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 of our shows, including this one, at asco.org/podcasts. My name is Brittany Harvey, and today I'm interviewing Dr. Jyoti Patel and Dr. Natasha Leighl, co-chairs on “Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2023.3.” Thank you for being here, Dr. Patel and Dr. Leighl.

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. Patel and Dr. Leighl, who have 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 start us off on the content of this episode, Dr. Patel, this living clinical practice guideline for systemic therapy for patients with stage IV non-small cell lung cancer without driver alterations is being updated on a regular basis. Could you provide some background information on the process for these living guidelines?

Dr. Jyoti Patel: The ASCO Living Guideline offers continually updated recommendations based on review of systemic randomized controlled trials. We bring a panel of experts together that includes representatives from Ontario Health as well as ASCO patient representatives. We review phase III studies and other published studies between the times from July 2022 and October 2023 for this most updated guideline. We think about the size of the populations that are being tested, what kind of interventions we have, the outcomes. We certainly look at PFS, as well as OS, but also toxicity, and overall response rates. We prioritize randomized trials and really look for studies that have large sample sizes. We exclude studies that were only meeting abstracts and really look at those that are published in peer-reviewed journals. 

When we weigh the evidence, we really think about a number of factors. So what is the strength of the evidence, what’s the sample size, and how we can make recommendations for our patients based on the totality of the data. Certainly, because this is such a rapidly evolving field, one of the things we are looking at is how to update in real-time these guidelines. So for this coming year, for example, these guidelines are published and we look forward to quarterly updates and, again, incorporate the latest evidence.

Brittany Harvey: Great. Thank you for that explanation on the background and how these living guidelines are developed. 

So, Dr. Leighl, could you describe what the key changes are from the expert panel?

Dr. Natasha Leighl: So what we try to do in the guidelines for this latest publication, was really try and streamline the way we set up a format to make it much easier for people to use. In terms of new recommendations, we made sure to include more recent studies of additional PD-1 or PD-L1 inhibitors, for example, cemiplimab in combination with chemotherapy, or the combination of durvalumab and tremelimumab with chemotherapy, both of these in unselected patients, so with any PD-L1 expression, of course, this continues with pembrolizumab with or without chemotherapy, atezolizumab with chemotherapy combinations, and, of course,  nivolumab and ipilimumab with and without chemotherapy. And so it really is just an update on all of the potential options. In the discussion, we’ve really tried to go through some of the nuances in the trials just to help when you’re discussing with patients or discussing with your oncologists, how to figure out which of these is best for you.

Brittany Harvey: Excellent. It's helpful to have all of the recommendations listed out together so that clinicians and patients know all of the available options available to them. 

So then, Dr. Patel, what should clinicians know as they implement these changes into their clinical practice?

Dr. Jyoti Patel: I think it's important to stress that our decision-making in the treatment of advanced non-small cell lung cancer is really reliant on adequate biomarker testing. And so the way we approach this is our assumption that all appropriate patients undergo molecular testing and have PD-L1 testing to help us get the best therapies. And the other assumption is that patients and physicians are engaging in a dialogue to better assess patient preferences to have a better understanding of performance status, for example, as we think about allocating therapy. One thing that we’ve been able to do is to take the evidence and break it up by histology as well as PD-L1 expression for patients who don’t have driver alterations. Based upon that, think about the toxicity data with, for example, dual immunotherapy versus chemo-immunotherapy for subsets of patients, and so hopefully get some guidance to clinicians as they are going through this process.

The other part of the guideline was to, once again, look at second-line and subsequent therapies. So, again, for patients who get immunotherapy alone, the recommendation is that patients get a carboplatin-based doublet in the second-line setting. We still do not know if patients should get immunotherapy after that initial exposure, that is the subject of ongoing randomized studies. We also have stronger evidence than ever that docetaxel is an appropriate second-line agent, but there are other options there, so docetaxel and ramucirumab, as well as other single-agent chemotherapies.

Brittany Harvey: Understood. Those are key points for informed and shared decision-making and are helpful for clinicians to know. 

So then, Dr. Leighl, in your view, how will these guideline recommendations impact patients with non-small cell lung cancer without driver alterations?

Dr. Natasha Leighl: Thanks. So, we’re really hoping that with all of the focus in the first-line setting, that more patients will receive immunotherapy with or without chemotherapy in the first-line setting to really bring it forward and really make sure that patients can start benefiting as soon as possible. As Dr. Patel said, one of the challenges, of course, is to understand who might benefit most with a chemotherapy-free approach and have treatments in sequence versus who really needs everything together. And so, we’ve really tried in the discussion to try and help with that discussion both from a provider and patient perspective. So, we want more people to get immunotherapy to help improve their outcomes and also to potentially get it earlier.

I think the other thing, and Dr. Patel has brought this up, but when we looked at what happens after first-line therapy, we really have very limited recommendations. And so it’s our real hope that this will spur the community on to do even more studies to help us figure out what’s next and how do we really improve outcomes for our patients after all of these great first-line options have stopped working.

Brittany Harvey: Absolutely. I appreciate you touching on those key points for improved outcomes for patients with non-small cell lung cancer.  

Finally, Dr. Patel, you have mentioned some ongoing randomized clinical trials and so has Dr. Leighl. So, what are the ongoing developments that the living guideline expert panel is monitoring for future updates?

Dr. Jyoti Patel: We will continue to update guidelines based on available literature, but certainly, there are a number of trials that we should be reading out in the next year or so, looking at combinations of immunotherapy in the second-line setting. Certainly comparing novel agents to docetaxel in the second-line settings, and things like antibody-drug conjugates. So certaintly that’s evidence that we hope to incorporate this evidence within the guideline with the idea that  we can really help clinicians and patients recognize or at least identify the best options for treatment for them. 

Brittany Harvey: Definitely. Well, we’ll look forward to the expert panel's review and interpretation of this evidence as those trials read out. And appreciate all of your work on this guideline update and we’ll hear more as these guidelines are continuously updated. Thank you so much for your time today, Dr. Patel and Dr. Leighl. 

Dr. Jyoti Patel: 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 asco.org/living-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, 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 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, experiences, 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.

 

 

Systemic Treatment of Patients with Metastatic Breast Cancer Resource-Stratified Guideline

Dr. Banu Arun and Dr. Sana Al Sukhun share recommendations from the newest ASCO resource-stratified guideline on systemic treatment for patients with metastatic breast cancer. They describe the importance of this new guideline, the four-tier resource setting approach, key recommendations, and implementation considerations. Recommendations are discussed for systemic therapy for HER2-positive, triple-negative, and hormone receptor-positive metastatic breast cancer, across Basic, Limited, and Enhanced resource settings. Drs. Arun and Al Sukhun highlight the importance of this guideline for clinicians and patients in regions with limited resources to optimize cancer care.

Read the full guideline “Systemic Treatment of Patients with Metastatic Breast Cancer: ASCO Resource-Stratified Guideline” at www.asco.org/resource-stratified-guidelines."

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/resource-stratified-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest disclosures in the JCO Global Oncology, https://ascopubs.org/doi/10.1200/GO.23.00285 

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. Banu Arun from the University of Texas MD Anderson Cancer Center in Houston, Texas, and Dr. Sana Al Sukhun from Al Hayat Oncology Practice in Amman, Jordan, co-chairs on “Systemic Treatment of Patients with Metastatic Breast Cancer: ASCO Resource-Stratified Guideline.” 

Thank you for being here, Dr. Arun and Dr. Al Sukhun.

Dr. Banu Arun: Thank you for having us. 

Dr. Sana Al Sukhun: Thank you. Pleasure to join you.

Brittany Harvey: And before we discuss this guideline, I'd just 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 the guests who have joined us today on this episode, are available online with the publication of the guideline in the JCO Global Oncology, which is linked in the show notes.  

Then, to jump into the content of this guideline, Dr. Al Sukhun, can you first provide an overview of the scope and the purpose of this guideline? 

Dr. Sana Al Sukhun: Sure. And again, thank you, Brittany. Pleasure to join you. This guideline is really interesting and very important. It addresses the care and treatment of the most common cancer worldwide, particularly metastatic breast cancer, taking into consideration different availability of resources, particularly in countries with limited resources. As you know, most of us are aware of the importance of clinical practice guidelines improving outcomes for patients in medicine, not only in oncology, but most of those guidelines are developed in countries that are highly resourced. So their applicability in countries of limited resources that lack infrastructure and resources is definitely limited because they cannot really adopt and adapt to those guidelines, which makes resource adapted or resource stratified guidelines quite important and helpful. First, to clinicians caring for patients so that they can properly allocate resources, prioritize how to use therapy for patients, but also even policymakers to allocate resources and plan graduated implementation of science to improve outcomes for their patients according to the progressive availability of resources. 

So we're talking about breast cancer, the most common cancer worldwide. And not only is it the most common cancer worldwide, but also more than two-thirds of new cases are diagnosed in countries of limited resources. Unfortunately, they also carry the burden of more than 70% of the mortality attributed to breast cancer. Another challenge is that the median age for the patients affected with breast cancer in countries of limited resources is indeed at least a decade younger than Western societies, which adds to the burden, not only the social, but also the economic burden of cancer. And unfortunately, presentation in these countries is mostly locally advanced, metastatic breast cancer, therefore comes the focus on helping our colleagues in countries of limited resources to care for patients according to the resources available, not only in countries of limited resources, even colleagues practicing in less fortunate areas within countries that are highly resourced.

Brittany Harvey: Excellent. Thank you for providing that background information for this guideline. 

So then you've just described how many countries and areas have different resources. So, Dr. Arun, could you describe the four-tier resource setting approach that this expert panel used?

Dr. Banu Arun: Yeah, Brittany, that's a good question. I think it's important to know where we started and what infrastructure we used. So for developing resource stratified guidelines, ASCO has adopted its framework from the four-tier resource setting approach, which was actually developed by the Breast Health Global Initiative, and we employed modifications to that framework based on the disease control priorities. What this framework emphasizes is also that variations can be present not only between countries, but actually within countries with disparities, for example, differences between rural and urban areas within one country.  

So the four settings are obviously basic, limited, enhanced, and maximal settings. The basic setting includes core resources or fundamental services that are really absolutely necessary for any public health, primary health care system to function at all. These include services that are typically applied in a single clinical interaction. For example, vaccination is feasible for highest need populations.  

The next tier would be the limited setting. That includes countries or settings with second-tier resources or services that are intended to produce major improvements in outcomes, such as incidences and cost effectiveness. Unlike the basic setting, it can involve single or multiple interactions with providers or healthcare services.

Then the third tier is the enhanced setting, where the services are optional but important, and these services should ideally produce further improvements in outcome and increase the number of quality of options and also individual choices, maybe countries having the ability to track patients and links to registries. 

And then the last one is of course, the maximal setting that includes high-level, state-of-art resources and services that are available in some high-resource countries.

Brittany Harvey: Thank you for describing that framework and the approach that the panel used.

So then I'd like to move on and talk about the key high-level recommendations of this guideline for systemic therapy for metastatic breast cancer across those three lower tiered resource settings - the basic, limited, and enhanced resource settings. So, Dr. Al Sukhun, could you start with the recommendations across these settings focusing on HER2-positive breast cancer? 

Dr. Sana Al Sukhun: Sure. You know, HER2-positive metastatic breast cancer is one of the most aggressive subtypes of breast cancer. However, its outcome has been transformed with the introduction of HER2-targeted therapy. So, apart from patients who suffer from congestive heart failure or limited compromised ejection fraction, which can be evaluated on a case-by-case basis, patients are candidates for HER2 targeted therapy. When we made the recommendations according to the availability of resources, we started in a gradual approach. So, in a maximal setting, you treat patients with HER2-positive metastatic breast cancer in the frontline setting using the combination of trastuzumab, pertuzumab, and taxanes or endocrine therapy if patients have limited disease burden, or if they have the recurrence after a long disease-free interval. Usually, the combination of trastuzumab and pertuzumab with taxane is used. But then again, clinicians can use navelbine, considering good data from the HERNATA trial about its efficacy as compared to taxanes and even also, we recommended platinum therapy according to availability.  

However, if pertuzumab is not available, you go to the next level where we recommend offering, again, chemotherapy, be it taxane, navelbine, platinum, with trastuzumab, or even without trastuzumab if trastuzumab is not available. So, something to keep in mind, chemotherapy is not without efficacy in this aggressive subtype. It is not as good as when you use the combination with HER2-targeted therapy, but it still works. Patients and clinicians in this era of biologic therapy immunotherapy tend to think only pricey medications are the ones that can be used for treatment and improving outcome. However, definitely adding help with targeted therapy is great whenever it's available. But if it's not available, chemotherapy still could be used in a sequential manner. We listed all possible chemotherapeutic options starting with taxanes, navelbine, platinums, even CMF, capecitabine.  

When it comes to second-line therapy, including those patients who relapse within 12 months of adjuvant therapy, the optimal line of treatment would be trastuzumab deruxtecan. However, if it's not available, we recommend to be offered with successive or progressive preference, if it's not available, T-DM1 could be used. If it's not available, capecitabine and lapatinib could be used. If it's not available, trastuzumab with chemotherapy could be used. If it's not available, we go back to the sequential use of chemotherapy, including adriamycin, taxanes, platinums, capecitabine, or even CMF. 

Brittany Harvey: I appreciate you reviewing those recommendations for HER2-positive breast cancer. 

So then, moving along, Dr. Arun, what are the recommendations for patients with metastatic triple-negative breast cancer?

Dr. Banu Arun: Thank you, Brittany. Triple-negative breast cancer, of course, is one of the serious subgroups of breast cancer. About 10 to 15% of patients have triple-negative breast cancer. What I will do is I will divide it into the three-tier settings as well as first-, second-, and third-line therapies. 

For patients with triple-negative PD-L-negative metastatic breast cancer in the limited settings and even enhanced settings, single-agent chemotherapy rather than combination chemotherapy should be recommended as the first-line. However, if patients are symptomatic or have immediate life-threatening disease, combination chemotherapy can be offered. 

For patients with triple-negative breast cancer that are PD-L1 positive, they may be offered in addition to chemotherapy, an immune checkpoint inhibitor, as first-line therapy, most probably in enhanced settings and in basic and limited, of course, chemotherapy. When you move on to the second-line for metastatic breast cancer in patients with or without previous PD-L1 checkpoint inhibitors, clinicians can offer palliative or best supportive care in the basic setting. In the limited setting, chemotherapy with anthracyclines, taxanes, platinums are options. And in the enhanced setting if sacituzumab govitecan is not available, chemotherapy would be an option.

Now, when we move on to the third-line setting for triple-negative breast cancer, clinicians can actually offer chemotherapy and/or palliative care, depending really on the status of the patient.

Brittany Harvey: Excellent. Thank you for providing those recommendations for triple-negative breast cancer. As you mentioned, it's one of the rarer forms of breast cancer. So then, Dr. Al Sukhun, I'd like to move into the last section of patients, actually the most common, but hormone receptor-positive breast cancer. What are those recommendations? 

Dr. Sana Al Sukhun: Thank you, Brittany. As you mentioned, it's the most common subtype worldwide. The rule of the thumb is sequential hormonal therapy, depending on availability. So, whatever you have hormonal therapy, sequential hormonal therapy unless pending visceral crisis or symptomatic disease, it's recommended that you offer sequential single-agent chemotherapy, unless it's a real visceral crisis, where we recommend combination chemotherapy. That's a classic in all our guidelines. 

When considering frontline hormonal therapy, again, I will start from the maximal level and gradually recommend according to availability. So in enhanced levels in many countries now, we have generic CDK4/6 inhibitors, which increase their availability. So we do recommend hormonal therapy with CDK4/6 inhibitors. Upon progression or when they are not available, on progression, you move to the second line of hormonal therapy. If you have liquid biopsy, check for PIK3CA mutation. Sometimes you do have the liquid biopsy, but you do not have alpelisib to offer to your patients with hormonal therapy, then it's okay, you still can move to second-line fulvestrant with everolimus. Sequentially, you can move forward to fulvestrant by itself if you do not have everolimus. And even you can sequence tamoxifen until your patient stops responding to hormonal therapy then you can offer sequential single-agent chemotherapy. 

Brittany Harvey: Thank you, Dr. Al Sukhun for providing those recommendations. 

So then, Dr. Arun, what should clinicians do when we do not have access to receptor assessment? What is recommended for best practices for management of those patients?

Dr. Banu Arun: So, Brittany, that's an important question. There are some basic settings where unfortunately, immunohistochemistry for ER/PR HER2neu determination is not available. Our group really recommends in these cases that clinicians may presume hormonal receptor positivity and offer tamoxifen in most cases. It is expected that IHC would be available in limited and, of course, enhanced settings.

Brittany Harvey: Great. Thank you for providing that information. 

So further, what else should clinicians know as they implement these recommendations, Dr. Arun? 

Dr. Banu Arun: It's very important that we, all healthcare provider clinicians, really know the data. I think reading the guidelines or knowing about first and second line therapies is obviously important, but the devil is in the details. And I think knowing the publications and subgroup analyses, if needed, because every patient is different and sometimes the recommendations cannot go by the books. You really need to do an assessment of the patient and see in which setting you are and then make the most of the guidelines that are recommended. It's to guide. The name is guidelines. It's to guide. And ultimately, it's the clinician's responsibility to find the best available therapy for the patient. And sometimes that includes no treatment and supportive care.

Dr. Sana Al Sukhun: Totally agree with Dr. Arun. They are there to support the clinician decision. After all, the clinician is the one who sees the patient, who can evaluate the patient from all aspects — social aspect, physical aspect, the tumor aspect. So it's not just about the tumor, it's about the patient and the environment where the clinician is treating the patient. However, I believe there is support to the clinician not only in treating the patient, but also on addressing priorities for research to improve outcomes for patients in different resource settings. There is also support for the clinicians to help them advocate for improving care for patients in a strategic way, where they prioritize resource allocation. So they are there to support the clinician at all levels, not only when treating patients, but when advocating for patients, when helping patients to make decisions, when they're discussing with their health officials and policymakers.  

Brittany Harvey: Absolutely. Those are excellent points that you both made about individualizing patient care for the specific person in front of you. So then, finally, Dr. Al Sukhun, how will these guideline recommendations impact patients with metastatic breast cancer globally? 

Dr. Sana Al Sukhun: The ultimate goal for anything we do, including guidelines, is to improve outcomes for patients worldwide. They are there to support clinician decisions, empower clinicians to optimize care for their patients, to advocate for improving outcomes for patients by strategically allocating resources according to the most impactful strategy. They help clinicians to identify areas for research that are needed according to the resources available to them. They are there to guide policymakers, again, also implementing strategies to implement science that could improve outcomes in an efficient way for their societies. So hopefully, all these, with our research, with our advocacy, with our health policy, with our treatment decisions, hopefully all these will improve outcomes for breast cancer patients and ultimately reduce mortality, particularly in less fortunate, limited resource settings for patients everywhere.

Brittany Harvey: Absolutely. We hope that these guidelines improve outcomes and quality of life for patients worldwide. 

So I want to thank you both so much for your work to develop this guideline. There's certainly a large amount of recommendations, so I encourage our listeners to read the full guideline, which is linked in the show notes. And I want to thank you so much for your time today, Dr. Al Sukhun and Dr. Arun.

Dr. Sana Al Sukhun: Thank you for having us.

Dr. Banu Arun: Thank you, Brittany.

Brittany Harvey: And thank you to all of our listeners for tuning into the ASCO Guidelines podcast. To read the full guideline, go to www.asco.org/resource-stratified-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app 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.

 

 

Germline Testing in Patients with Breast Cancer: ASCO-SSO Guideline

Dr. Isabelle Bedrosian and Dr. Mark Robson discuss the new guideline from ASCO and SSO on germline testing in patients with breast cancer. They discuss the framework for which patients should be offered BRCA1/2 testing, and what additional moderate- and high-penetrance genes may be considered for inclusion in germline testing. They highlight key aspects of personal and family history, recommendations surrounding counseling for genetic testing, and the impact for patients and their families. They close the conversation with a discussion of gaps in the research.
Read the full guideline, Germline Testing in Patients with Breast Cancer: ASCO-SSO Guideline

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/breast-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest disclosures in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO.23.02225

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. Isabelle Bedrosian from the University of Texas MD Anderson and Dr. Mark Robson from Memorial Sloan Kettering Cancer Center, co-chairs on “Germline Testing in Patients with Breast Cancer: American Society of Clinical Oncology – Society of Surgical Oncology Guideline.” 

Thank you for being here, Dr. Bedrosian and Dr. Robson.

Dr. Mark Robson: My pleasure.

Dr. Isabelle Bedrosian: Thank you, Brittany.

Brittany Harvey: 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. Bedrosian and Dr. Robson, who have 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 jump into the content of this particular guideline, Dr. Bedrosian, could you give us a general overview of both the scope and the purpose of this guideline?

Dr. Isabelle Bedrosian: Yeah, sure. So, in the last decade or so, the whole area of clinical cancer genetics has become incredibly complicated, driven, I think, predominantly by the development of extended gene testing. And in the midst of this complexity, our goal here was to try to give providers a framework through which they can think about the application of germline testing within their patient population. And really, this framework was to help them think through how testing can best be applied to patients that were both newly diagnosed with breast cancer or had a history of breast cancer, and also to help them think through the scope of that testing as well, be it BRCA testing or testing in a more extended fashion that may help inform longer-term decisions such as risk management.

Brittany Harvey: Absolutely. We appreciate your efforts to provide recommendations in this framework in this complicated space. 

So then, I'd like to review the key recommendations of this guideline developed by the expert panel. So first, Dr. Robson, who should be offered BRCA1/2 testing?

Dr. Mark Robson: Thank you. I think this is perhaps one of the most important things that comes out of the guideline is that we, and the group, are now recommending that anyone who is either newly diagnosed with breast cancer at or before the age of 65, or if they're over 65 and have suggestive personal or family history criteria, or alternatively, if they are eligible for PARP inhibitor therapy, that they all be offered BRCA1 or BRCA2 testing. And the same would hold for women who had a personal history of breast cancer but were not currently under active treatment if their diagnosis had been made at or before 65 or older than that, with certain criteria then they should be offered testing. This is a much simpler way to look at things than the rather complicated existing criteria, which are perhaps a bit both difficult to remember and unfortunately inadequately sensitive in a setting where there is such critical, both therapeutic and risk management implications to the identification of a BRCA mutation.

Dr. Isabelle Bedrosian: Yeah, I would just also add there's one other, albeit a much smaller group of women for whom BRCA testing could be considered, and those are women who develop a second primary breast cancer. That's another group that I think we can think about offering BRCA1/2 testing to.

Brittany Harvey: Understood. I appreciate you both reviewing those recommendations for BRCA1/2 testing. 

So, Dr. Bedrosian, which additional genes does the panel recommend including in germline testing?

Dr. Isabelle Bedrosian: Yeah. So, in this area, outside of BRCA genes, Brittany, I think the panel didn't make any definitive recommendations or any specific genes that should be tested for. I think the panel felt that the decision to test for additional high penetrance genes and also for some moderate penetrance genes should be guided by the specifics of the individual case, whether the identification of germline mutations makes sense in the context of the patient's personal history and family history. So, in other words, is there a worrisome pattern in the family that might warrant more in-depth testing beyond BRCA, and also considerations around the implications of those test results. Would it change the management for the patient themselves? Either in the treatment of the index malignancy, which, in the case of most of these non-BRCA genes, there really is not changes to the management of the breast cancer that would be offered based on the finding of non-BRCA germline mutations. But potentially, the finding of a non-BRCA germline mutation in a breast cancer patient might help better understand risks of second malignancies that would then be addressed. And certainly for families as well of the patients, identifying those that are carriers could offer opportunities for risk assessment, risk mitigation.

Dr. Mark Robson: I totally agree with Dr. Bedrosian. One thing I think it's important to understand is that most commercial testing done in the United States now does involve panels of genes. And the group certainly did not intend to suggest that that practice not continue. So, I think if somebody has a history of breast cancer, I think the panel felt that it would at least be reasonable to test for breast cancer susceptibility genes. However, this issue of do you test for all of the high penetrance genes when the family history doesn't suggest it, was certainly something we left open and we did not want to imply that it was obligatory to test for a large number or large panel of genes that weren't related to the patient's personal and family history. So, in other words, didn't want to imply that it was obligatory to do an extremely large panel just as a target of opportunity, if you will.

Dr. Isabelle Bedrosian: I think really a key part of these guidelines was that we wanted to afford the oncologist flexibility. It's very difficult beyond BRCA to be prescriptive. There are so many considerations about testing, and those considerations will be applied differently in every patient context. So, we really wanted to let providers know that while they have to think about these other genes, and oftentimes there'll be good reason to do these other genes as part of the overall germline testing, again, that it's not obligatory to do so. It's not a fixed set that needs to be tested for. And really, the understanding of the patient's personal history, family history, therapeutic goals, and risk assessment goals should be used to determine kind of the ultimate scope of the testing.

Brittany Harvey: It sounds like these decisions will be individualized, based on patient characteristics and with working between both patients and their clinicians. So that leads into my next question. But, Dr. Robson, how should patients with breast cancer considering genetic testing be counseled?

Dr. Mark Robson: With this recognition and emphasis on the therapeutic implications for patients with breast cancer, both surgical and potentially systemic using PARP inhibitors, the approach has gradually moved away from the concept of testing for personal utility, in other words, just wanting to know, and more towards the idea of this being a clinically useful test that's to some extent necessary for the appropriate management of a fair number of patients. And so the counseling is usually- the pre-test counseling is perhaps more educational than we have used in the past, rather than this extensive discussion of whether or not somebody wants to know. Obviously, it's always the patient's ultimate decision whether or not to be tested, and we have to give them the same elements of education that we would have given back in the day. But it can be delivered in a more didactic type of context rather than necessarily the back and forth that takes place with formal genetic counseling. 

Now, for patients who have complicated or extensive family histories or who have histories that may suggest predispositions other than those for breast cancer, the type of thing that Dr. Bedrosian was talking about earlier, they could certainly benefit, again, from a more formal evaluation by a provider experienced in cancer genetics to help select what the scope of the testing should be, for instance, and also to help interpret those results. And certainly anybody who had a pathogenic variant or a likely pathogenic variant identified should be considered for meeting with somebody who's experienced in clinical cancer genetics both to interpret and also to help with family expansion when appropriate. 

Brittany Harvey: Excellent. Thank you for reviewing those recommendations from the expert panel. So, Dr. Robson just touched on this a little bit, but Dr. Bedrosian, how will these guideline recommendations affect patients with breast cancer and their families?

Dr. Isabelle Bedrosian: Yeah, so from a patient perspective, I think there are two ways that these recommendations can impact care. For those women that are identified as germline carriers, specifically with BRCA, it will open the door for receipt of PARP inhibitors, which are currently recommended for patients that are high-risk primary cancer or those with metastatic disease. The other ways that patients will be affected by a germline testing is really in this idea of second cancer risks. Some of these germline mutations are well established to carry risks of either second primary breast cancer or non-breast malignancies. And understanding those risks will allow the patients and their providers to create management strategies, be they surgical or with more intensified screening that will help them mitigate the effects of that germline-driven risk. 

And I think similarly for the families of patients, the ones the proband has identified, I think that family now has a very real opportunity to better understand their cancer risks and again be able to more effectively manage those risks through either surgical or non-surgical means. And it would really underscore the family component of this. I think oftentimes oncologists are very much focused on the patient and admittedly so that is the person that has the most immediate needs. But I think there's a real opportunity to extend efforts at prevention and early detection by identifying the at-risk family members and allowing them the opportunity to access care that mitigates their cancer risks and hopefully will improve survival outcomes in so doing. So, I think the opportunities for families here to understand risks of germline testing is a really important one to underscore from these recommendations.

Dr. Mark Robson: Just to expand a little bit on what Dr. Bedrosian was saying, I think this is a very important place for collaboration between the oncology community and the clinical cancer genetics providers because the oncologist is pretty occupied taking care of all of their cancer patients, and the approach to people who are unaffected is a little bit different. People who are unaffected perhaps do need a little bit more pretest counseling to understand the pros and cons of choosing to be tested for the familial mutation. And certainly that idea of family expansion is something that's well known to clinical cancer genetics providers and that's really very much something that they can help the primary oncologists do.

Brittany Harvey: Absolutely, these recommendations have impacts beyond just the individual patient, but also for their families as well. 

So then, finally, Dr. Robson, what are the outstanding questions regarding germline testing in breast cancer?

Dr. Mark Robson: Oh, there are so many. Where should I start? I think over the years we've become, as a community, pretty comfortable managing individuals who have BRCA1 or BRCA2 mutations. There are certainly some questions left, but there's a lot of familiarity with that. I think the challenges expand into these what we call moderate penetrance genes and how to guide people with alterations in those genes. Because except for PALB2, which is relatively uncommon, many of the other genes don't really have the same implications for therapy because it's not clear that they confer PARP sensitivity. It's not at all clear that they have high risks of contralateral breast cancer. And even in the unaffected setting, we know that there's a wide distribution of risk for people who carry these alterations. And some individuals with these alterations probably are not at increased risk at all because they have protective factors. So the management of breast cancer susceptibility genes beyond BRCA1 and BRCA2 is still very much in evolution. They can't be handled exactly the same way as a woman with a BRCA carrier.  

And then, of course, this issue of how much should we test and what do we do with some of the alterations that we find, if you will, out of context, what are the implications for that and what's the most appropriate management? Those still remain very much open questions. So I think there's still plenty of work to do.

Dr. Isabelle Bedrosian: Yeah, I agree. I think one of the enormous challenges has been the disconnect between how rapidly our technology has advanced and can sequence alterations, and our ability to really understand the biologic and clinical implications, which really is a time-dependent issue. We need to see over time how patients do for us to understand the implications of some of these germline findings. So that disconnect is a very difficult one to bridge, particularly, I think, for surgical oncologists because they are oftentimes referred patients who don't have a cancer history, necessarily, or have a distant history, and really the concern is “I'm at risk and I would like to reduce my risk.” And it becomes very difficult to counsel patients as to the benefits of risk reduction when we don't have such a great handle on the degree to which they are actually at risk. So that really is a significant gap, I think, for surgeons in particular to have to contend with.

Brittany Harvey: Definitely. We'll look forward to answering some of those questions as we learn more and get more data to address those gaps.

 So I want to thank you both so much for your work to develop this framework for genetic testing in breast cancer, and thank you so much for your time today, Dr. Robson and Dr. Bedrosian.

Dr. Isabelle Bedrosian: Thank you, Brittany. 

Dr. Mark Robson: Thank you for having us.

Brittany Harvey: 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/breast-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, 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.

Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Rapid Recommendation Update

Dr. Rohan Garje reviews the latest rapid recommendation update for the ASCO guideline on systemic therapy in men with metastatic castration-resistant prostate cancer (mCRPC). He reviews what prompted the guideline update and the latest recommendation from the expert panel. Dr. Garje also discusses future updates to the guideline that are currently underway, and outstanding questions regarding systemic therapy for mCRPC.
Read the latest update, “Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Guideline Rapid Recommendation Update” at www.asco.org/genitourinary-cancer-guidelines.

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/genitourinary-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest disclosures in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO.23.02128 

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. Rohan Garje from Miami Cancer Institute Baptist Health South Florida, lead author on “Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Guideline Rapid Recommendation Update. 

Thank you for being here today, Dr. Garje.

Dr. Rohan Garje: Thank you so much for having me, Brittany.

Brittany Harvey: And then, just before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines in 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. Garje, who has joined us on this episode today, are available online with the publication of the update in the Journal of Clinical Oncology, which is linked in the show notes. 

So then, to dive into the content of this rapid update, first, Dr. Garje, what prompted this rapid update to the guideline on Systemic Therapy for Metastatic Castration Resistant Prostate Cancer?

Dr. Rohan Garje: So, last year, when we did a rapid update on ASCO prostate cancer guidelines, we recommended the addition of 177Lutetium-PSMA-617, also called as PLUVICTO, as a treatment choice for patients who have PSMA-positive metastatic castrate-resistant prostate cancer. After that approval, the primary imaging modality at the time of this initial drug approval was based on gallium-68, which was used in that clinical trial, which was VISION. Since then, we have access to a couple of new radiotracers, one of them being piflufolastat, also called as PYLARIFY, and the newer one called flotuflastat F-18, which is also called as POSLUMA, as additional imaging agents to detect PSMA-positive lesions. So, our expert panel group, along with my co-chairs, we thought to add these additional choices for patient selection because this provides the treating physicians additional options because there really are nuances involved in these imaging agents. So this helps broaden the access to  177Lutetium-PSMA-617 for patients.

Brittany Harvey: Excellent. I appreciate you providing that background that the panel was reviewing.  

So then, based on this updated information, what is the updated recommendation from the expert panel?

Dr. Rohan Garje: So, for the new recommendation, the guideline expert panel recommends use of one of these three radio tracers, that is Ga-68PSMA-11, or piflufolastat F-18, or flotufolastat F-18 as one of the radiotracer choices to screen for PSMA-positive lesions on a PSMA scan, and potentially select the patients for PSMA 177lutetium. This way, we can use one of these three agents rather than previously recommended, as per FDA approval of gallium 68. Now, the reason behind these additional agents, as I was just alluding in my initial comment, is each institution may have access to one of these agents. For example, if a patient had a testing done by piflofolastat or flotufolastat, if they are PSMA-positive, it has shown PSMA-positive lesions as per VISION criteria, we do not suggest the patients to undergo gallium-68 assisted imaging again to have selection for PSMA lutetium therapy. This is unnecessary imaging. We have evidence now, based on the studies which were done with PYLARIFY, which is the piflofolastat, or the flotufolastat, which is POSLUMA, that they are equally good in detecting PSMA-positive lesions. This way we can avoid additional imagings for patients who are being screened for lutetium therapy.

Brittany Harvey: Understood. Thank you for reviewing the expansion of this recommendation to avoid additional or unnecessary screening. 

So then, Dr. Garje, the article mentions complete updates to the metastatic castration-resistant prostate cancer guideline are underway. At a high level, could you review what new evidence the panel will look at to update their evidence-based recommendations?

Dr. Rohan Garje: There have been a lot of developments in the last year, at least, in the treatment strategies for patients with metastatic castration-resistant prostate cancer. Earlier this year, we have seen three big updates about the first-line metastatic CRPC setting, where the combination of PARP inhibitors and androgen receptor pathway inhibitors were tested. For example, in the TALAPRO-2 study talazoparib and enzalutamide, and in the MAGNITUDE study, it was niraparib along with abiraterone. And in the PROpel study, the combination of olaparib and abiraterone was studied. Now, all these combinations have recently received FDA approval with specific nuances with regards to folks who have biomarker positive disease, specifically BRCA1 and BRCA2 mutations. So it is very important to refine this information so that it is utilized by practicing oncologists so that it is widely adapted in their day to day practice.

Now, in addition, we also are focusing on addressing the need for utilizing biomarkers. The biggest thing for us to offer a biomarker driven therapy is to do biomarker testing. So we are focusing on making sure patients with advanced prostate cancer get biomarker testing so that we can identify who are the patients who get selected. So this particular guideline update is addressing those needs. 

And then most recently at the recent ESMO meeting, we also noted the positive data from a study called PSMAfore, which evaluated PSMA 177lutetium prior to chemotherapy. This study showed positive data based on progression free survival benefit. So we will review additional data from that and see if a guideline update can be done based on this. So it is very exciting. Now, obviously, we are also waiting on survival data on all the studies. So we are closely monitoring all the updates on these studies so that we can provide more rational guidance based on not only progression-free survival benefit in a specific cohort and also to see if it helps with overall survival improvement.

Brittany Harvey: Absolutely. We'll look forward to the panel's review of this evidence and then future updates to this full guideline. 

So then, finally, Dr. Garje, you've alluded to awaiting some data. So could you expand on what are some of the outstanding questions regarding systemic therapy for metastatic castration-resistant prostate cancer?

Dr. Rohan Garje: I would put that in two boxes. Number one, sequencing. So we are excited that we have a broad spectrum of options; androgen receptor pathway inhibitors, chemotherapy options, radium-223. We have lutetium based options and then biomarker selected patients with PARP inhibitor combinations and select patients with benefit for checkpoint inhibitors. Now, the biggest question we need to answer is how to sequence them, which drug or which combination strategy is ideal for one particular patient. Now, obviously, when we do not have clinical trials which have addressed sequencing, we as an expert panel would want to come up with some mechanism of consensus to identify what treatment sequence would work best for patients. So that is an important question this guideline panel wants to address where we can give some generic information as a consensus, based on the experience of the panel to give guidance for practicing physicians the best sequencing. 

Now, second thing, very equally important, is biomarkers. This particular guideline update is also focusing on making sure biomarker testing is universal. There has been a lot of evidence that biomarker testing happens very late in the course of the disease, which precludes a lot of patients from these combination strategies. So this particular guideline also is focusing on what biomarkers to be tested and at what time frame, so that they can be optimally utilized for the patient treatment so that the patients will have the best cancer outcomes.

Brittany Harvey: Definitely, those are important questions for personalized care for people with prostate cancer.  

I want to thank you so much for your work on this rapid update and your ongoing work on the updates to the full guideline, Dr. Garje, and thank you for your time today.

Dr. Rohan Garje: Sure, thank you so much.

Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full guideline update, go to www.asco.org/genitourinary-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. 

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.

 


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