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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

Systemic Therapy for SCLC Rapid Update

Dr. Greg Kalemkerian reviews the latest evidence-based rapid update from the Expert Panel on systemic therapy for small cell lung cancer. He discusses the updated recommendations for patients with limited-stage SCLC based on the ADRIATIC trial, and for patients with relapsed SCLC based on the DeLLphi-301 trial. Dr. Kalemkerian shares insights on what these changes mean for clinicians and patients, and highlights new trials in progress to provide more options for patients diagnosed with SCLC.

Read the full rapid update, “Systemic Therapy for Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update” at www.asco.org/thoracic-cancer-guidelines.

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/thoracic-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-24-02245

 

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. Greg Kalemkerian from the University of Michigan, lead author on, “Systemic Therapy for Small Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update”.

Thank you for being here today, Dr. Kalemkerian.

Dr. Greg Kalemkerian: Thank you. Thank you for the invitation.

Brittany Harvey: Great. 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. Kalemkerian, who has joined us here 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, Dr. Kalemkerian, what prompted this update to the Systemic Therapy for Small Cell Lung Cancer Guideline, which was previously published in 2023?

Dr. Greg Kalemkerian: So even though the original guideline only came out a year ago, the past year we've seen two significant advances in small cell lung cancer with two reports, one in limited stage with the addition of immunotherapy, the other in the addition of a new immunotherapeutic agent in relapsed small cell lung cancer.

Brittany Harvey: It's great to have this new data in the small cell lung cancer space. So based on these new changes, what are the updated recommendations from the expert panel?

Dr. Greg Kalemkerian: So the first recommendations have to do with patients with limited-stage small cell lung cancer based on the ADRIATIC trial which added consolidation durvalumab for patients who had not had progression after standard chemotherapy and radiotherapy. And this study demonstrated a significant improvement in overall survival with about a 10% improvement in both 2- and 3-year overall survival, up to a 57% overall survival at 3 years for the patients receiving consolidation durvalumab. And based on those findings, we updated the recommendation for the standard treatment for limited-stage small cell lung cancer such that it included the use of consolidation immunotherapy with durvalumab for up to two years in patients who had had no disease progression, and completion of concurrent chemoradiotherapy for limited-stage small cell lung cancer. Of course, those patients would be those who do not have contraindications to the use of immunotherapy.

As a corollary to that recommendation, for patients who have poorer performance status, so performance status of 3 or 4, who had had initial treatment perhaps with sequential chemotherapy and radiotherapy, if their performance status improves with their initial treatment, then it would also be reasonable to add consolidation immunotherapy for those patients as long as their performance status maintains improvement and they have no evidence of progression.

The other update of the guidelines had to do with patients with relapsed small cell lung cancer and that was based on the DeLLphi-301 trial which was a phase II study looking at the use of tarlatamab, a bispecific T cell engager, binds to both DLL3 and CD3 in order to increase the immune killing of small cell lung cancer cells. So what this study did was it treated patients who had had at least two prior regimens. So this is third-line or beyond was what the population that this study looked at. And the majority of these patients had already had some immune checkpoint therapy. They all had good performance status and it did allow patients with brain metastases to be included in the study. When we look at the patients who received the approved 10 milligram dose of the drug, the response rate was about 40%. Responses were seen in both patients with sensitive and refractory based on the time since their prior treatment and the median duration of response was 10 months, which is much better than anything we've seen before with relapsed small cell lung cancer patients, remembering that all these patients were also third-line or beyond.

So based on the results of the DeLLphi-301 trial, we updated two of the recommendations regarding relapsed small cell lung cancer. In the first one, we stated that in patients with relapsed small cell lung cancer with a chemotherapy free interval of less than 90 days, single agent systemic therapy would be considered standard of care, and that the preferred agents would include topotecan, lurbinectedin, or, now, tarlatamab. We did mention as a qualifying statement that single-agent chemotherapy is preferred over multi-agent chemotherapy. And the second recommendation was that, in patients with relapsed small cell lung cancer with a chemotherapy interval longer than 90 days, the rechallenge with a platinum-based regimen or single-agent chemotherapy was considered standard and the preferred agents for single agent therapy would be topotecan, lurbinectedin, or tarlatamab being added in the recent study. Tarlatamab was approved by the FDA for use in patients with relapsed small cell lung cancer with no stipulations with regard to the treatment.

Brittany Harvey: Understood. I appreciate you describing those updated recommendations along with the supporting data for both limited stage small cell lung cancer and relapsed small cell lung cancer.

So then, what should clinicians know as they implement these new and updated recommendations into practice?

Dr. Greg Kalemkerian: So with regard to the ADRIATIC trial or the consolidation durvalumab being added for limite- stage small cell lung cancer patients, I think the important considerations are that this was done after patients had demonstrated no progression of disease after chemotherapy and radiotherapy, so the initial treatment does not change with platinum-etoposide plus definitive radiotherapy being recommended. The addition of durvalumab is going to be potentially useful in patients generally with good performance status, so performance statuses 0 to 1, and we still have to pay attention to the patients who may have contraindications to immunotherapy, things like interstitial lung disease, autoimmune problems that do occur in patients with small cell lung cancer where they develop paraneoplastic autoimmune syndromes such as Lambert-Eaton myasthenic syndrome. Those patients with those types of preexisting conditions would not be good candidates for immunotherapy use. So still having the tailored treatment to the individual patient is what's most important. The duration of the durvalumab was up to two years and not beyond that, so following those specific guidelines for the use of durvalumab in patients with limited-stage small cell lung cancer.

With regard to tarlatamab, tarlatamab is an immunotherapy treatment. So we still do have the exclusions of people who have had prior severe immune-related adverse events, people who have pneumonitis, people who have interstitial lung disease, people with autoimmune neurologic problems we can see with small cell lung cancer, these patients should not be considered good candidates for the use of tarlatamab. The study did include patients who had had treated and asymptomatic brain metastases and there is some evidence that tarlatamab can have some control of brain metastases. So that's not necessarily an exclusion.

Tarlatamab does have some other specific considerations to it in that 51% of patients had some evidence of cytokine release syndrome (CRS). Only 1% of those patients had grade 3 CRS. So even though they had frequent fevers and hypotension and hypoxia, it was generally not severe. But this concern for CRS and also for neurologic complications after treatment does require that patients be admitted to the hospital for a 24-hour observation period during the first and second doses. Subsequent to that, patients can be observed for some time after the infusion in the outpatient setting. But they also need to have very clear and strict guidance for when they go home about what things to look for. Looking for fevers, looking for shortness of breath, looking for any neurologic changes. It's a good idea for them to have a caregiver with them in order to observe them during that time. Most of these complications occur during the first or second cycles, but it is a drug that is going to require significant education not only of our staff, but also of the patients in order to ensure that the drug's used safely.

Brittany Harvey: Absolutely. For these new options, it's important to tailor cancer treatment to the individual patient and the factors that you mentioned and be mindful of these potential toxicities.

So, it's always great to learn of new options for patients. But in your view, how will this update impact patients with small cell lung cancer?

Dr. Greg Kalemkerian: Well, clearly we need longer term follow up. So, with regard to the limited-stage small cell lung cancer situation, that's a curative situation. We have been curing patients with limited-stage disease with chemotherapy and radiotherapy for several decades now, but the cure rates were relatively low with about 25%, 30% of people becoming long term survivors. Now the hope is with the durvalumab being added on, that we can increase that number. Thus far, we have three-year survival data with a three-year survival of 57% overall survival and we're hoping that that is maintained over time and that we're not just delaying recurrences, but that we're actually preventing recurrences and helping people live longer, as has been seen with non-small cell lung cancer in stage III disease with the addition of durvalumab to chemoradiotherapy. So hopefully, we will be improving the cure rate of people with limited-stage small cell lung cancer.

There are several other trials with immunotherapy in this space coming down the line and we're anxiously awaiting not only long term follow up from ADRIATIC, but also initial data from studies such as KEYLYNK and ACHILLES and NRG-LU005. So all of these studies in the next few years are hopefully going to guide treatment for limited-stage small cell lung cancer and hopefully improve the long term survival outcomes. With regard to tarlatamab, unclear at this point what the long term outcomes are going to be. Is a 40% response rate substantially better than what we've seen before? Well, lurbinectedin also had about a 40% response rate in patients who had sensitive disease, but the duration of response does look longer. And there are some patients now who have been on this study that are doing very well for quite long periods of time with the drug. So, the hope here also is that we will have some small subset of patients who continue to do better for long periods of time. Whether that'll translate into a cure or not, way too early to know, clearly hoping to add another brick in the wall so that we can keep the disease at bay, at least for a longer period of time for these patients.

How we will integrate tarlatamab into the regimens is a bit unclear. Whether most of us will start using it as second-line therapy or whether we will use perhaps lurbinectedin or topotecan as second-line and tarlatamab as third-line, we're all going to have to work that out based on the potential toxicities, the logistical complications of using the drug at this point in time. But I do think that it's nice to have more options to add to our armamentarium to treat this very, very challenging and difficult disease.

Brittany Harvey: Definitely. So, you've just discussed the need for both longer term follow up here along with some important ongoing trials in this space. So we'll look forward to future readouts of those trials to learn more about caring for patients in small cell lung cancer.

So, I want to thank you so much for your work to rapidly update this guideline and thank you for your time today, Dr. Kalemkerian.

Dr. Greg Kalemkerian: Okay. Again, thank you for the invitation, Brittany, and thanks to ASCO for developing the whole guideline structure to help all of us take better care of our patients.

Brittany Harvey: Absolutely. And also thank you to all of our listeners for tuning in to the ASCO Guidelines podcast. To read the full update, go to www.asco.org/thoracic-cancer-guidelines.  You can also find many of our guidelines and interactive resources in the free ASCO Guidelines App 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.

Therapy for Stage IV NSCLC With Driver Alterations: ASCO Living Guideline Update 2024.2

Dr. Lyudmila Bazheova share the latest updates to the ASCO living guideline on therapy for stage IV non-small cell lung cancer with driver alterations. She discusses changes for patients with EGFR driver alterations in both the first- and second-line setting, and reviews the evidence supporting these updated recommendations, from trials such as MARIPOSA, MARIPOSA-2, CheckMate 722, and KEYNOTE-789. 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 2024.2.” at www.asco.org/living-guidelines.

TRANSCRIPT

This guideline, clinical tools, and resources are available at http://www.asco.org/living-guidelinesRead 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-24-02133

 

Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges and advances in oncology. You can find all the shows, including this one at asco.org/podcasts.  

My name is Brittany Harvey and today I'm interviewing Dr. Lyudmila Bazhenova from University of California San Diego Moores Cancer Center, lead author on “Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2024.2.”

Thank you for being here, Dr. Bazhenova.

Dr. Lyudmila Bazhenova: It is my pleasure.

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. Bazhenova, who has joined us on this episode today, are available online with the publication of the guideline update in the Journal of Clinical Oncology, which is linked in the show notes.

So then, to kick us off on the content here, Dr. Bazhenova, this living clinical practice guideline for systemic therapy for patients with stage IV non-small cell lung cancer with driver alterations is being updated routinely as a living guideline. So what prompted the update to the recommendations in this latest version?

Dr. Lyudmila Bazhenova: Living ASCO Guidelines are developed to keep up with rapidly changing evidence which affect treatment of our patients with lung cancer. In this recently published guideline, we reviewed new evidence for patients with metastatic lung cancer harboring driver alterations. We reviewed evidence from four published studies, MARIPOSA, MARIPOSA-2, CheckMate 722 and KEYNOTE-789 that resulted in updated guidelines.

Brittany Harvey: Great. And then based off those four trials that you just mentioned, what are the updated recommendations for patients with stage IV non-small cell lung cancer and an EGFR exon 19 deletion or exon 21 L858R substitution?

Dr. Lyudmila Bazhenova: In the previous guideline, we detailed FLAURA 2 study which was presented and published in the past. In this guideline, we specifically highlighted a phase 3 MARIPOSA trial which took patients with untreated advanced non-small cell lung cancer which harbored classical EGFR mutations such as EGFR deletion 19 and L858R. In this study, patients were randomly assigned to receive amivantamab plus lazertinib or osimertinib or lazertinib alone. And the study showed that the primary endpoint which was progression-free survival was longer with amivantamab plus lazertinib compared to osimertinib, and numerically the progression free survival was 23.7 months with ami-lazertinib versus 16.6 months with osimertinib which was statistically significant. The challenge that we have to face when discussing that option with our patients is increased toxicity with amivantamab and lazertinib combination. For example grade 3 treatment adverse events were 75% with amivantamab and lazertinib and 43% with osimertinib. So this will require shared decision making between our patients and ourselves. We also noticed in the guidelines that there was a subgroup analysis of that study showing that the patients with a higher disease burden, central nervous metastasis or brain metastasis as well as disease which considered to be a higher risk such as commutation, for example, p53 and liver metastasis, they might benefit from intensified therapy. However, another thing that we are highlighting in the guideline is that at this point we do not know how the intensification of therapy will change overall survival of our patients. So one needs to take into account increased toxicity with that combination.

Brittany Harvey: So then Dr. Bazhenova, in addition to those updates for first line therapy, what are the updated recommendations for second line therapy?

Dr. Lyudmila Bazhenova: For patients who have progressive disease on osimertinib or other EGFR tyrosine kinase inhibitors, we also updated our guidelines highlighting MARIPOSA 2 study. In the MARIPOSA 2 study, patients were assigned to chemotherapy versus amivantamab plus lazertinib plus chemotherapy versus amivantamab plus chemotherapy. And both of the amivantamab arms showed superiority in progression-free survival compared to chemotherapy alone arm and therefore this becomes an additional treatment option for our patients who develop resistance to osimertinib. In addition, we also updated the results which highlight the lack of efficacy of immunotherapy in the patients who progressed on osimertinib.

There were two studies that we highlighted. One of them was a CheckMate 722 which randomly assigned patients with metastatic non-small cell lung cancer whose cancer has progressed on EGFR tyrosine kinase inhibitor to receive either chemotherapy or chemotherapy plus nivolumab which is an immune checkpoint inhibitor.

And the second study was KEYNOTE-789 which had a very similar study design. Again, patients who progressed on EGFR TKI also were assigned to receive chemotherapy plus pembrolizumab or chemotherapy alone and in both of those studies there was no improvement in progression-free survival when adding immunotherapy to chemotherapy. So for all your patients who are progressing on EGFR tyrosine kinase inhibitors and you’re thinking if additional immunotherapy is necessary, we now have two randomized phase 3 studies telling us that immunotherapy should not be used in addition to chemotherapy for patients who develop progression on osimertinib.

Brittany Harvey: Understood. I appreciate you talking about the evidence that supports these latest recommendations from the expert panel.

So then you've already touched on this a little bit in mentioning shared decision making and discussing toxicity with these new therapies, but what should clinicians know as they implement these new recommendations and how do these new recommendations fit into the previous recommendations made by the panel?

Dr. Lyudmila Bazhenova: Our previous recommendations did not include a MARIPOSA trial, so did not include amivantamab and lazertinib. So in our current guidelines for patients with newly diagnosed treatment-naive EGFR classical mutations, we have three options. Number one is osimertinib, number two is osimertinib plus chemotherapy based on the FLAURA study that we highlighted in the prior version of the guidelines. And the third is amivantamab plus lazertinib. At this point, we do not have any randomized head-to-head studies of those combinations with an exception of FLAURA 2 which is osimertinib plus chemo versus osimertinib. And so the decisions will have to be made on a cross-trial comparison, taking into account patient wishes if they would like to receive chemotherapy or amivantamab plus lazertinib, understanding that this combination will result in increased toxicity.

Brittany Harvey: Absolutely. I appreciate you detailing those considerations.

So then finally, what do these new options mean for patients with non-small cell lung cancer and an EGFR alteration?

Dr. Lyudmila Bazhenova: As a patient, it is important to also be aware of what options we have and have a direct dialogue with the physician, with the treating physician, trying to understand what option will fit with each individual patient's goals, life goals, as well as toxicity concerns.

Brittany Harvey: Definitely. It's always great to have more options for patients and it's also important to discuss all of those options with their clinician as well.

So I want to thank you so much for your work on this update and thank you for your time today, Dr. Bazhenova.

Dr. Lyudmila Bazhenova: My pleasure.

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 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.

 

 

 

Management of Locally Advanced Rectal Cancer Guideline

Dr. Sepideh Gholami and Dr. Aaron Scott join us to discuss the latest evidence-based guideline from ASCO on the management of locally advanced rectal cancer. They review the recommendation highlights on topics including assessment, total neoadjuvant therapy, timing of chemotherapy, nonoperative management, and immunotherapy. Additionally, we discuss the importance of this guideline for both clinicians and patients, and the outstanding research questions in the management of locally advanced rectal cancer.

Read the full guideline, “Management of Locally Advanced Rectail Cancer: ASCO Guideline” at www.asco.org/gastrointestinal-cancer-guidelines.

TRANSCRIPT 

This guideline, clinical tools, and resources are available at www.asco.org/gastrointestinal-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO.24.01160 

 

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. Aaron Scott from the University of Arizona Cancer Center and Dr. Sepideh Gholami from Northwell Health, co-chairs on, “Management of Locally Advanced Rectal Cancer: ASCO Guideline.” Thank you for being here, Dr. Scott and Dr. Gholami.

Dr. Sepideh Gholami: Thank you for having us.

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. Scott and Dr. Gholami, who have joined us here today, are available online with a publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes.

So then, to kick us off on the content of this episode, Dr. Gholami, first, what is the purpose and scope of this guideline on locally advanced rectal cancer?

Dr. Sepideh Gholami: Well, I think, historically, this is the group of patients with locally advanced rectal cancer for which we've used multiple therapies to address their management. And with the advent of the total neoadjuvant approach, we really have seen tremendous changes. So the purpose really of these guidelines was to consolidate the various approaches that we've had in several clinical trials and to provide the oncology community a general management recommendation guideline to really optimize the outcomes for these patients. And I would further notice that with the specifics to like which patients are included for these, so we define patients with locally advanced rectal cancer as any of those patients with T3 or T4 tumors and/or lymph node positive disease.

Brittany Harvey: Great. I appreciate you providing that background and context of this guideline.

So then, next, I'd like to review the key recommendations of this guideline. So, Dr. Scott, starting with the first section of the guideline, what are the recommendations for assessment of locally advanced rectal cancer?

Dr. Aaron Scott: Yeah, thank you. So really, we were charged with trying to answer, I think, several very important questions as it comes to the treatment of locally advanced rectal cancer. And the first step in doing so is to define the patient group. So, as far as the first section goes in the assessment, we were really charged with defining what locally advanced rectal cancer means. We think that this is best done with a high resolution pelvic MRI, dedicated rectal sequence prior to any treatment for risk assessment and proper staging, and the use of standardized synaptic MRI is recommended that includes relation of the primary tumor to the anal verge, sphincter complex, pelvic lymph nodes, the mesorectal fascia, otherwise known as the MRF, and includes assessment of the EMVI tumor deposits and lymph nodes.

Brittany Harvey: I appreciate you reviewing those highlights for assessment of locally advanced rectal cancer.

So following that, Dr. Gholami, what does the panel recommend regarding total neoadjuvant therapy and standard neoadjuvant chemotherapy for patients with proficient mismatch repair or microsatellite stable tumors?

Dr. Sepideh Gholami: Yeah, thanks so much for that question, Brittany. I would say that the guidelines really provide a lot more details, but in general, the consensus was that TNT should be offered as really initial treatment for patients with low rectal locally advanced rectal cancers or those who have higher risk for local and distant metastases. Those risk factors included anyone with either T4 disease, extramural vascular invasion and/or tumor deposits identified on the MRI for any threatening of the mesorectal fascia or the intersphincteric plane.

Brittany Harvey: Excellent. So then, Dr. Gholami just discussed who should be offered TNT. But Dr. Scott, what are the recommendations regarding timing of TNT?

Dr. Aaron Scott: So the way I take this question, think about this question, is a lot of the work that we put toward defining whether chemoradiation plus consolidation versus induction chemotherapy is the right choice, and there are a lot of implications to consider in this situation. The panel recognizes that the decision to proceed with chemoradiation followed by chemo versus chemotherapy followed by chemoradiation often depends on logistics regarding the time to treatment start, concern for distant metastases, and desire for local control that may impact surgical decision making.

When we look at the subgroup analysis for overall survival of patients treated with TNT, it doesn't seem to matter which approach you take. Either induction or consolidation doesn't seem to have an impact on overall survival. However, there are other outcomes that may be of importance. Based on the CAO/ARO/AIO-12 randomized phase II trial, both pathologic complete response rates and sphincter sparing surgery were numerically higher with consolidation chemo. That said, there was no difference in disease free survival. So if you have a patient that really wants to consider some sort of sphincter sparing surgery, or a patient has a highly symptomatic disease burden, etc., these are patients that we would recommend starting with chemoradiation followed by consolidation chemotherapy.

Brittany Harvey: Understood. And so you have both mentioned radiation included in treatment regimens. So Dr. Gholami, what is recommended in the neoadjuvant setting? Short course radiation or long course chemoradiation?

Dr. Sepideh Gholami: Yeah, we actually had a really long discussion about this, but I think in general the consensus was that if radiation is included in any patient's treatment plan, neoadjuvant long course chemoradiation is preferred over short course RT for patients with locally advanced rectal cancer. And really the recommendation was based on the long term results that we've seen from the RAPIDO phase 3 clinical trial, which showed a significant higher rate of five year local regional failure with a total neoadjuvant approach with short course of 10% compared to the standard chemo RT with only 6% of the local recurrence rate. So that's why they opted for the long course, if the patients can actually tolerate it.

Brittany Harvey: Excellent. I appreciate reviewing the recommendation and the supporting evidence that the panel reviewed to come to those recommendations.

Then following that, Dr. Scott, for those patients who have a complete clinical response after initial therapy, what is recommended regarding nonoperative management?

Dr. Aaron Scott: First, I would like to just say that this is really an area that still remains somewhat controversial and needs more investigation to best select patients for this approach. This topic was not systematically reviewed for the ASCO guideline. However, the expert panel was surveyed and most agreed with the time interval used in the OPRA phase 2 trial, which assessed patients for clinical complete response within eight weeks plus or minus four weeks after completion of TNT. Expert panel members and reviewers noted that if the radiation therapy component of TNT is delivered first, then an eight week interval following subsequent chemotherapy may result in a prolonged period of no treatment and therefore a first assessment of this response in this scenario would occur on the earlier side of the recommended interval. If a near clinical complete response is noted, then reevaluation within eight weeks is recommended to assess for developing a clinical complete response.

Brittany Harvey: Absolutely. That information is helpful to understand what is recommended regarding nonoperative management and clinical complete responses.

Then the final clinical question, Dr. Gholami, for patients with tumors that are microsatellite instability high or mismatch repair deficient, which treatment strategy is recommended?

Dr. Sepideh Gholami: Yeah, I think we really came up to summarize that in general, when there is no contraindication to immunotherapy, then patients with MSI high tumors should be really offered immunotherapy. The evidence for this recommendation was relatively low, though, just due to the small sample size of the data that's currently available. But we did want to highlight that the data is very promising, but a definitive recommendation by the committee should be validated in future larger clinical trials.

Brittany Harvey: Absolutely. Well, thank you both for reviewing the highlights of these recommendations for each clinical question.

Moving on, Dr. Scott, in your view, what is the importance of this guideline and how will it impact both clinicians and patients with locally advanced rectal cancer?

Dr. Aaron Scott: This would be the first guideline through ASCO to spell out management options for locally advanced rectal cancer. This has largely been needed due to the increased number of phase II and III trials investigating the specific patient population that have investigated a variety of different TNT approaches and treatment combinations utilizing systemic therapy, radiation, and surgical treatment. So, in this guideline, we really set out to define what locally advanced rectal cancer is, have organized and analyzed impactful large randomized studies to address multimodality therapy, and have consolidated this information into what we consider a concise and generalizable approach to help clinicians and patients individualize their management based on specific clinical pathologic features of their cancer.

Brittany Harvey: Yes, this has been a mountain of work to review all the evidence, consolidate it into a concise review of that evidence, and develop recommendations for best clinical practice for management of locally advanced rectal cancer.

So then, finally, to wrap us up, Dr. Gholami, what are the outstanding questions regarding management of locally advanced rectal cancer?

Dr. Sepideh Gholami: Yeah, I think I just want to reiterate, Brittany, what you mentioned, this was a tremendous amount of body work, and we really would like to thank the committee and everyone from ASCO to help us with creating these general guidelines. I think one of the outstanding questions really still remains is the use of circulating tumor DNA as a management tool for patients with rectal, locally advanced rectal cancer. And also, I think outside of what we can think of the straightforward populations to deduce from PROSPECT, be really interested to see what other patient populations, for example, could also potentially maybe avoid radiation therapy. And lastly, I think we really wanted to highlight that this guideline really focuses on the locally advanced, and it would be great to see future guidelines for early stage rectal cancer which will be forthcoming.

Brittany Harvey: Definitely. We'll look forward to answering those outstanding questions and for upcoming guidelines on earlier stage rectal cancer. So, I want to thank you both so much for, as you said, the tremendous amount of work that went into these guidelines and thank you for taking the time to speak with me today, Dr. Scott and Dr. Gholami.

Dr. Aaron Scott: Thank you.

Dr. Sepideh Gholami: Thank you so much for having us. Appreciate it.

Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines Podcast. To read the full guideline, go to www.asco.org/gastrointestinal-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please read 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.

 

Management of Stage III NSCLC Rapid Update

Dr. Megan Daly presents the latest rapid recommendation update to the ASCO management of stage III NSCLC guideline, based on data from the phase III randomized LAURA trial, presented at the 2024 ASCO Annual Meeting, and subsequently published. She discusses the results of the trial, shares the updated recommendation from the expert panel, and the impact for both clinicians and patients. We also discuss future research in the area and exciting new developments to watch out for in the field.
Read the full rapid update, “Management of Stage III Non-Small Cell Lung Cancer: ASCO Rapid Guideline Update” at www.asco.org/thoracic-cancer-guidelines.

TRANSCRIPT  

This guideline, clinical tools, and resources are available at www.asco.org/thoracic-cancer-guidelines. Read the full text of the guideline and review authors’ disclosures of potential conflicts of interest in the Journal of Clinical Oncology, https://ascopubs.org/doi/10.1200/JCO-24-01324.

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. Megan Daly from the University of California Davis Comprehensive Cancer Center, lead author on, “Management of Stage III Non–Small-Cell Lung Cancer: ASCO Rapid Guideline Update.”

Thank you for being here today, Dr. Daly.

Dr. Megan Daly: Thanks for having me, Brittany.

Brittany Harvey: Great. 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. Daly, who has joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes.

So then, to start us off on the content of this update, first, this guideline was updated based off new evidence presented at the 2024 ASCO Annual Meeting. Dr. Daly, could you describe the trial that prompted this rapid update to the management of stage III non-small cell lung cancer guideline?

Dr. Megan Daly: The trial that prompted this update is the LAURA trial. The LAURA trial was a phase III randomized trial conducted in patients with unresectable stage III non-small cell lung cancer harboring EGFR mutations, either exon 19 deletions or L858R insertions. Patients in this trial were randomized 2:1 between the third generation EGFR tyrosine kinase inhibitor osimertinib or placebo, and osimertinib or placebo were continued until progression or other reasons for discontinuation. Osimertinib was found to provide a considerable benefit in progression free survival, with a hazard ratio of 0.16. The median progression free survival for patients randomized to osimertinib was 39.1 months, and for patients on the placebo arm, it was 5.6 months. We did not yet have overall survival data from the LAURA trial. The data is not mature, but the considerable progression free survival benefit noted with osimertinib has drawn a lot of interest to this trial.

Brittany Harvey: Absolutely. Thank you for describing the results of those trials and the endpoints. So then, based on this new evidence, what is the updated recommendation from the guideline expert panel?

Dr. Megan Daly: The updated recommendation from the panel is that patients with unresectable stage III non-small cell lung cancer with an EGFR exon 19 deletion or exon 21 L858R mutation may be offered consolidation osimertinib after definitive chemoradiotherapy, which can be either platinum-based chemotherapy and thoracic radiation given either concurrently or sequentially. Our evidence quality is moderate and the strength of the recommendation is strong.

Brittany Harvey: Great. And thank you for reviewing both the strength of the recommendation there as well as the evidence quality rating. So it's great to have this new option for patients. So what should clinicians know as they implement this new recommendation?

Dr. Megan Daly: I think it's important for clinicians to know when they're counseling patients about considering osimertinib to understand that first, the LAURA trial enrolled patients who had common EGFR mutations. So exon 19 deletions or L858R mutations. Patients with other uncommon EGFR mutations were not included in the trial. It's important to know that overall survival data is not yet mature. We do not know yet whether the use of consolidation osimertinib leads to a survival benefit at this time. We only know that it leads to a progression-free survival benefit as compared to placebo. I think it's also important to know that there was increased toxicity noted on the experimental arm. Grade 3 or higher adverse events was significantly higher with the use of osimertinib. So these are all important considerations when counseling patients and considering the use of osimertinib.

Brittany Harvey: Absolutely. Those are definitely key points, as you mentioned, to consider. And you've already touched on this a little bit. But how does this change impact patients living with stage III non-small cell lung cancer?

Dr. Megan Daly: We do see in the LAURA trial a rather remarkable benefit for progression-free survival. The progression-free survival, as I already mentioned, increased from 5.6 months median on the control arm to 39.1 months on the experimental arm with consolidation osimertinib. So this is an exciting new option for patients with unresectable stage III non-small cell lung cancer who have one of these mutations to extend their progression-free survival by almost three years. And we hope that this progression-free survival benefit will end up translating into a considerable overall survival benefit as well. So, certainly, the overall survival data is eagerly awaited.

Brittany Harvey: Definitely, this is a promising option for patients, and we look forward to future readouts of long-term data on this trial. So that's one of the outstanding questions here. But what other outstanding questions are there regarding the management of stage III non-small cell lung cancer?

Dr. Megan Daly: I think what many of us question when we look at this data is whether we could extrapolate to the use of other targeted agents with other less common oncogenic driver mutations. Unfortunately, the answer is we simply don't know yet. We hope to see some ongoing data in the resectable setting. Doing randomized trials with rare oncogenic drivers in unresectable stage III lung cancer is very difficult, unfortunately, and there's always a degree of extrapolation for clinicians when trying to figure out how to best manage our patients. But for me, that's one of the biggest outstanding questions I think specifically ties into interpreting the LAURA trial and other related trials in patients with oncogenic driver mutations.

I think there's still many outstanding questions about how we continue to improve outcomes for our patients with unresectable stage III non-small cell lung cancer, questions about how we optimize our radiation regimens to have the best possible local control while reducing toxicity. We still need to continue to have randomized trials looking at questions on optimizing radiation, optimizing concurrent chemotherapy, whether there are any settings where we might be able to reduce or omit chemotherapy in place of some of these newer agents. These are all outstanding questions that hopefully will be answered over the next several years. We also continue to have open questions about when patients are more appropriate for surgery and more appropriate for non-surgical options, those borderline patients with N2 nodes who may technically be surgical candidates or could potentially be downstaged with neoadjuvant therapy. So, I think there's a lot of exciting work going on in stage III right now.

Brittany Harvey: Absolutely. We'll look forward to that more data that you mentioned for more optimal individualized options for these patients with stage III non-small cell lung cancer.

And I want to thank you so much for your time to rapidly update this guideline based off new evidence presented and then published. And thank you for your time today, Dr. Daly.

Dr. Megan Daly: Thank you, Brittany. It's great to be on here.

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/thoracic-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.

 

 

 

Selection of Germline Genetic Testing Panels in Patients with Cancer Guideline

Ms. Charité Ricker, MS, CGC and Dr. Nadine Tung, MD, FASCO share updates from the new ASCO guideline on selection of germline genetic testing panels in patients with cancer. They discuss highlights on family history collection, when and how multigene panel germline genetic testing should be used, which genes are generally recommended for testing, and how germline genetic testing interfaces with somatic genetic testing. Ms. Ricker and Dr. Tung also note the importance of the guideline and the impact of these new recommendations on clinicians and patients with cancer.

Read the full guideline, “Selection of Germline Genetic Testing Panels in Patients with Cancer: ASCO Guideline” at www.asco.org/molecular-testing-and-biomarkers-guidelines.

TRANSCRIPT

GDL 24E13

This guideline, clinical tools, and resources are available at www.asco.org/molecular-testing-and-biomarkers-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.24.00662 

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. Nadine Tung, a medical oncologist from Beth Israel Deaconess Medical Center in Boston, and Ms. Charité Ricker, a cancer genetic counselor with the Norris Comprehensive Cancer Center at the University of Southern California and Los Angeles General Medical Center, co-chairs on, “Selection of Germline Genetic Testing Panels in Patients with Cancer: ASCO Guideline.”

Thank you for being here, Ms. Ricker and Dr. Tung.

Dr. Nadine Tung: Pleasure. 

Ms. Charité Ricker: Thank you.

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. Tung and Ms. Ricker, 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 start us off first, Dr. Tung, could you provide us a broad overview of both the purpose and scope of this guideline?

Dr. Nadine Tung: Sure. A main impetus for creating the guideline is that oncologists are increasingly being tasked with ordering genetic testing for hereditary cancer risk for their cancer patients. More and more now, they may find themselves sending the test and then seeking guidance from genetic experts to interpret the result. And these panels range from focused tests with just a few genes to comprehensive ones that include over 100 genes. So it can be very overwhelming for an oncologist to be able to understand ordering these tests and explaining them to their patients. So, we believe that it was important to offer some guidance and direction on the use of these multigene panels.

Brittany Harvey: Thank you for setting the stage for this guideline and the recommendations that come from it.  

So then, Ms. Ricker, this guideline addresses four overarching clinical questions. I'd like to review the recommendations based on each of those questions for our listeners. So starting with that first question, what is the importance of family history collection in the setting of germline multigene panel testing and which elements of family history are the most important?

Ms. Charité Ricker: Thanks. As a genetic counselor, this is probably one of my favorite questions. I love the opportunity we have to sit with families and really dig into family history. But family history collection can be overwhelming and a big lift sometimes in busy clinics where genetics is not the focus. So, what we tried to do was to break down the key elements of what components of family history are most relevant to informing which test to do, and also the interpretation of those test results. And I like to think about the key pieces of family history as being the who, what, and when of somebody's family cancer history. Who was diagnosed with cancer within their close relatives? And usually we're most focused on first and second degree relatives. So parents, siblings, grandparents, aunts, and uncles. But sometimes relevant history might go into third degree relatives like cousins or more distant. So the who being who has cancer on both sides of the family? And then the what: what kind of cancer was it? Or where did that cancer begin? And the when: how old was that individual at the time they were diagnosed? Often we ask patients maybe not to fixate on the exact age, but to give us a sense. So was this somebody who was diagnosed young, in their 20s or 30s or older, in their 60s or 70s? Because that at least gives us a ballpark around what might be relevant for understanding the genes that should be included on somebody's test. 

When we are thinking about the purpose of this history, as Dr. Tung said, often the range of multigene panels might be from a few very focused genes to a very broad panel. Family history can help us understand if we need to step beyond the very focused genes that might be relevant for the patient's history of cancer and include other genes that might be indicated based on that family history. So I think about the role that family history has at the time of identifying which test to do and then its role when interpreting what those results mean for the patient and their family. Again, Dr. Tung touched on the fact that we are often testing very large panels. However, we still don't know everything. And so a negative genetic test result does not mean that somebody does not have additional cancer risk. And family history becomes our kind of guiding star for understanding if there is still a need to change the cancer screening and prevention management for that individual and their family members.

Brittany Harvey: Absolutely. Those are key points to understanding the important role of family history for each individual patient. 

So then moving to the next clinical question, Dr. Tung, what does the panel recommend regarding when and how multigene panel germline testing should be used, when germline genetic testing is indicated?

Dr. Nadine Tung: Well, anytime multiple genes need to be tested, as Ms. Ricker said, because of the patient's own personal cancer history, or their family history of cancer and close relatives, it's appropriate to consider a multi-gene panel. And in truth, we rarely ever just order one gene these days. Perhaps we do if there's a known gene like a BRCA gene in the family, and a relative just wants to know if they have that. But it's not all that common. And to be clear, as Ms. Ricker is going to cover a bit later, we are recommending that the appropriate minimal panel at least include the genes relevant to the patient's own cancer and the cancers in their relatives. 

But it's worth thinking about what are some of the pros and cons of ordering genes beyond that, beyond the patient's own cancer or their relatives? Well, for pros, since a patient's awareness of their family history may be incomplete, testing for a larger number of cancer risk genes does ensure that significant pathogenic variants won't be overlooked. And sometimes, even if the family history is well known, pathogenic variants in important cancer risk genes can be found even when the family history would not have prompted testing for them. But it is important for clinicians to appreciate that bigger isn't necessarily better. Some larger panels may include genes for which management of pathogenic variants is not entirely clear and that can create anxiety or unnecessary screening. And if the clinician receiving the information is not well informed about the significance of the finding, that can lead to unnecessary treatment and sometimes even unnecessary surgeries.  

And I'd add one final point that clinicians must have a system for communicating reclassification of these variants, the ones with uncertain significance that we call VUS. Because as the number of genes tested increases, so does the likelihood of encountering these VUS. So I would say those are some of the main points about when to use the panel and when to think about larger or smaller panels.

Brittany Harvey: Yes, I appreciate you reviewing both the pros and cons of expanding the genes included in multi-gene panel testing and the importance of variants of uncertain significance.  

So then Dr. Tung just touched on this, but speaking of minimal panels and which genes should be included, Ms. Ricker, what are the recommendations on which genes are generally recommended for germline genetic testing?

Ms. Charité Ricker: I think this is one of the harder questions that our group took on as we were working on this guideline. I don't think there is a one size fits all and one easy answer to this question. However, we chose to approach it by selecting the more common solid tumors that oncologists see in their clinics and the ones where the role of genetic testing is most well defined, as well as some very rare tumors where they're kind of easy. So we know that all individuals with certain types of cancers, even though they are rare, should merit genetic testing regardless of age of diagnosis, family history. 

And so as we approached it, and I really appreciate ASCO’s support in helping us develop some tools and tables that hopefully will be important aids for clinicians who are trying to make these decisions, we took the approach of, as Dr. Tung mentioned, selecting kind of a minimal set of recommended genes where most individuals who are informed in this area would agree that if nothing else was done, these genes should be done, but then also acknowledged that there is an expanding understanding about the impact of certain genes on cancer risk, and so then also provided a kind of a next level if somebody wanted to be more expansive, what we would recommend less strongly, but would be reasonable to consider. Then I think the other last piece that the committee felt was important to acknowledge is that given how common, in comparison to some of these genetic conditions that we work with, pathogenic variants in BRCA1 and BRCA2 can be, and also the important clinical impact of those genes along with the genes associated with Lynch syndrome, we felt that those were important to think about in the setting of all cancer patients. So if you're approaching a panel and thinking about what genes to include, looking at that kind of minimally recommended based on the patient's personal and family history, maybe the next level, which might include some additional genes that we have included in kind of the less strongly recommended category for those tumor types. And then consideration of the BRCA1 and 2 genes and genes associated with lynch syndrome, if they weren't already encapsulated by your other personal and family history considerations.

Brittany Harvey: Definitely. This was a big lift for the panel to tackle, and the tools and tables that you mentioned are all available online with the publication in the Journal of Clinical Oncology. So listeners who are looking for more specifics on that can definitely refer to those tools and tables there. 

Dr. Tung, the last clinical question: which patient should be offered germline genetic testing, who will have or who have previously had somatic genetic testing?

Dr. Nadine Tung: Identifying which genes identified through the tumor testing should trigger germline testing is really important for assessing our patients’ future risk of cancer and their relatives. So during the development of our guidelines, the ASCO expert panel became aware that the ESMO Precision Medicine Working group had updated their recommendations for this topic, namely germline testing in response to tumor test findings. And these recommendations were based on the Memorial Sloan Kettering IMPACT registry, which consists of nearly 50,000 tumors and paired germline testing. Given the sheer volume of that data and the methods that ESMO used, our group decided to use that as a framework to develop our recommendations. The ASCO guideline provides a list of genes that, if found in the tumor, a pathogenic variant in those genes may prompt germline testing. 

And we offered or proposed two different approaches. The first approach, which is broad and perhaps simplest, involves doing germline testing if a pathogenic variant is found in any of the genes listed. But then we offer a conservative approach to test the germline for all highly actionable genes, like BRCA1 and 2, or lynch genes that are found in a tumor, but for less actionable genes, testing the germline only if the pathogenic variant is found in a tumor relevant to that gene. So, for example, ATM, if found in breast cancer or pancreatic cancer, would trigger germline testing with this approach, but not if found in lung cancer, whereas with the permissive first approach, you would simply test the germline if any pathogenic variant is found in any of the genes on the list. This latter, more conservative approach, while less sensitive for identifying every germline pathogenic variant, increases the likelihood that a pathogenic variant found in the tumor will actually be germline. That approach considers the limited resources available, such as genetic counselors, and respects trying not to overwhelm a system already stressed.

Brittany Harvey: Thank you for reviewing both of those approaches and to you both for discussing all of the recommendations included in this guideline.  

Finally, to wrap us up, in your view, Ms. Ricker, what is the importance of this guideline and how will it impact both clinicians and patients with cancer?

Ms. Charité Ricker: I hope that this guideline can open the door for more expansive and appropriate utilization of germline genetic testing. For me, I think about, from both the clinical and patient side, for example, all ovarian cancer patients have had a recommendation for germline genetic testing for many years. Nonetheless, data from multiple research studies has shown us that ovarian cancer patients still are not being tested universally, and this has important implications for their treatment plans and for their family members. And so even in the setting where genetic testing, if I can use the phrase, has been simple in that it didn't require family history, it didn't require even a specific age criteria, it was just broad, testing is not utilized as much as it should be, and then you step into the world of more complex decision making around genetic testing for other tumor types. And so we hope that this provides a framework to simplify that decision making process for providers to increase appropriate utilization.  

And then from the patient perspective, I also think about the lack of access of genetic testing in underrepresented communities and minoritized patient populations where there's many barriers that patients face in accessing genetic services. And so if we can help reduce the barriers for this piece of the genetic testing process, my hope is that that opens up better avenues for access to testing, not just for patients with certain tumor types, but for all patients from all communities and backgrounds.

Brittany Harvey: Yes, those are key points. We hope that this guideline helps all patients access the appropriate testing to better inform their cancer prevention and treatment. 

So I want to thank you both so much for your work on this comprehensive guideline on germline genetic testing and all of the work that you put into it. And thank you for your time today. Ms. Ricker and Dr. Tung, 

Dr. Nadine Tung: Thank you.

Ms. Charité Ricker: It was a pleasure to be here. 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/molecular-testing-and-biomarkers-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.


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