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09/11/2022

Cancer Topics - Impact of Implicit Racial Bias on Oncology Patient Care and Outcomes

"What exactly is implicit racial bias? How does it manifest in physician-patient interactions and what is the potential impact of such bias on oncology patient outcomes? In this ASCO Education Podcast episode, Dr. Lauren M. Hamel (Wayne State University) and Dr. Nimish Mohile (University of Rochester) share their insights and perspectives on these topics with host Alissa A. Thomas (University of Vermont). If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org. Resources: Blindspot: The Hidden Biases of Good People by Mahzarin R. R. Banaji and Anthony G. Greenwald Implicit Associations Test 21-Day Racial Equity Challenge TRANSCRIPT Dr. Nimish Mohile: We had a patient a few years ago who had presented to our clinic, who ended up having a diagnosis of primary central nervous system lymphoma, and she was a young black woman, and it took about nine months for her to get that diagnosis. She had gone into multiple emergency rooms, she was only 22, had not had prior interaction with the medical system, but based on some of her socioeconomic demographics, her skin color, she was never given the kinds of testing that any other patient I think should have gotten at that time. Dr. Alissa Thomas: Hello, and welcome to another episode of ASCO Education podcast. Today's topic is, 'Implicit racial bias and its impact on patient care.' My name is Alissa Thomas, and I'm a Neurologist and Neuro-Oncologist at the University of Vermont College of Medicine. I'm delighted to introduce our two guest speakers; Dr. Lauren Hamel, who is an Associate Professor of Communication and Behavioral Oncology at Wayne State University, and the Co-program Leader of the Population Studies and Disparities Research Program of the Karmanos Cancer Institute. Her ongoing research explores racial attitudes in non-verbal behavior of oncology patients and physicians, and how those behaviors influence treatment decisions. Dr. Nimish Mohile is a Professor of Neurology and Oncology at The University of Rochester. He also serves as the Diversity Officer, Associate Chair for Career Development and Leadership, and Neuro-Oncology Division Chief. I'll get us started with the first question, really a definition. What do we mean by the term, 'implicit racial bias'? Dr. Lauren Hamel: I'm happy to go first. I think understanding what the definition of what implicit racial bias is is really important. You know, for good or for ill, over the last few years, it's gotten a lot more attention. And I think what's important to remember about it is that it's not a cognizant or a conscious bias, and it really is implicit, and it really is more of an association than it is anything else. It's sort of like the built-up associations that we have for anything. You know, could be race, could be gender, any number of demographics, or other factors that make our lives as humans. So, you know, associating certain aspects of people with positive or negative valuations. I think when we're talking about implicit racial bias, it's kind of like the gut associations we have for members of different racial groups. So often, it's kind of paired with "white is good, black is bad." It's a very rudimentary description of it, but that's a real kind of basic association that this kind of definition is built around. Dr. Nimish Mohile: Yeah, I would agree with that. I think that's a great discussion of what this is. I think it's really important for us to remember that these are really ingrained behaviors. It's, based on, you know, how we've been socialized and conditioned. And I think it's helpful to also put it in the framework of knowing that we all have some biases, we all probably have racial biases, and age biases, and other kinds of biases, and there's no sort of good or bad about having these biases. And the important part of this is, how do we recognize some of the biases that we have so that we can be more conscious about how we might fix those or think differently about the patients that we're seeing so that it doesn't result in actions that can be harmful. Dr. Lauren Hamel: Yeah, I agree with everything that Dr. Mohile just added. It is these ingrained associations. Really, it isn't about blaming ourselves for them because it's kind of the result of how our brains are structured. But to his point, it's once we know that we have them, and you know, we have data showing how they affect our behavior, it's then on us to identify them and then work to mitigate them. Dr. Alissa Thomas: Thank you. How do racial biases in patients and physicians influence treatment decisions or ultimately, how does this affect patient outcomes in Oncology? Dr. Lauren Hamel: You know, I think the direct relationship between certain biases and outcomes is still kind of being uncovered and investigated. But there are some interesting patterns that have been uncovered in data, specifically in the Oncology context too, because as you can imagine, a variety of professional organizations and groups examine the influence of bias. But just within Oncology, we see physicians who have higher levels of implicit bias who tend to see their patients who are black as less trustworthy, less educated, and less adherent to treatment recommendations. We also know that higher levels of implicit bias may be associated with less aggressive treatment programs recommended for black patients. We see some associations between levels of implicit bias and verbal dominance. But what was I think, especially interesting, is that we also see patterns of kind of perceptions from the patients that these physicians are communicating with. So, we see some manifestations in behavior, but we also see patients kind of "picking up" on some of these, whether or not they can identify them as bias necessarily. But for example, we see that patients who are seeing a physician with higher levels of implicit bias tend to see their physicians as less patient-centered, and less trustworthy. And I think that's a really important piece to identify because these biases are by definition kind of operating outside of our own consciousness, but they're manifesting themselves in a way that the people that we're communicating with are noticing. Dr. Nimish Mohile: We had a patient a few years ago who had presented to our clinic, who ended up having a diagnosis of primary central nervous system lymphoma, and she was a young black woman, and it took about nine months for her to get that diagnosis. She had gone into multiple emergency rooms, she was only 22, had not had prior interaction with the medical system, but based on some of her socioeconomic demographics, her skin color, she was never given the kinds of testing that any other patient I think should have gotten at that time. That was a real sort of wake-up call for our clinic, because as some of you know, this is a disease that we can really treat, especially in younger patients. So, there's real consequences to these kinds of biases. And some of them are personal, the ways they're ingrained in us, but some of them are built into our systems, and it's based on; what our ERs are designed like, where our hospital systems are, what kind of relationships we have with primary care physicians in different communities, what kind of access some of our patients have to primary care physicians. This patient in particular didn't have great access to primary care, so she didn't have this other team of people to advocate for her and to say, "Hey, you know, this is something really different in this patient, and we need to take this seriously." So, I think it can get complicated as we think about biases in ourselves, in other people, in the whole health system, and then also as we get out of our health system, some of these things are so influenced by what's going on in our communities. Dr. Lauren Hamel: Yeah, I think that's a really important point. At least with my work, I examine kind of at the interpersonal level, but these biases, as Dr. Mohile points out, exist in all levels of our society, and they interact, and they're-- I don't want to say additive, it's probably much more exponential. But yeah, it's a layer, on top of layer, on top of layer problem. Dr. Alissa Thomas: So, Dr. Mohile, you commented earlier that part of it is recognizing these biases in ourselves. Can you discuss how we might approach this with the impact of an anti-racism education program has been in your department and applications for that? Dr. Nimish Mohile: So, we've worked on anti-racism in our department on a couple of levels. One of the main levels is just building awareness for individuals to understand that they have biases, that they have racial biases, and starting to understand why they have those. So, we've gone through exercises like book clubs and talks, for people to really do some of that self-reflective work to understand how they've been conditioned as they grew up. I've personally done that and have found it very revealing and understood some of the biases that I grew up with based on people I was around, and based on my schools, and based on segregation within my school systems. So, I think that that's one piece of it. I think another piece is we don't often get taught about the history of racism in the United States, and how widespread it is. It's a very small part of our curriculums, and I think we have to take it upon ourselves now in our medical systems to go through that education. Education that we probably should have had all through elementary school, high school, college, we have to do that learning now because then we can really start seeing that impact of race on our society. And I think for physicians specifically, what is that impact of racism on patient care in our medical systems and how it's been ingrained in US healthcare. Understanding that we had segregated hospitals right until the 1960s, those are all thin

09/11/2022

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27 min
31/08/2022

Advanced Practice Providers – APPs 101: Physician Assistants (PAs) and Advanced Practice Registered Nurses (APRNS) in Oncology

"There are different types of advanced practice providers that you may meet in an oncology practice - PAs, APRNs, NPs, but what's the difference between them? In the second episode of ASCO Education's podcast series on Advanced Practice Providers (APPs), co-hosts Todd Pickard (MD Anderson Cancer Center) and Dr. Stephanie Williams (Northwestern University Feinberg School of Medicine), along with guest speakers, Leslie Hinds (Centura Health), Martin Clarke (Arizona Oncology), and Kathleen Sacharian (Main Line Health), break down the differences and similarities between physician assistants and advanced practice registered nurses, share what their days might entail in each of these roles in an oncology practice, as well as address some common misconceptions surrounding these types of APPs. Duration 35:52. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org." TRANSCRIPT Dr. Stephanie Williams: Hello and welcome to ASCO Education's Podcast Series Advanced Practice Providers, APP 101: Physician Assistants and Advanced Practice Registered Nurses in Oncology. I am your co-host, Dr. Stephanie Williams, with physician assistant, Todd Pickard. Today, we are joined by Leslie Hinds and Kathleen Sacharian, both of whom are nurse practitioners, along with physician assistant, Marty Clarke. All three of today's guests are a part of the APP Task Force. Thank you all for being on our panel today. Leslie, Kathleen, and Marty, could you please tell our audience a little bit about yourselves, starting with you, Leslie? Leslie Hinds: Good morning! I am a nurse practitioner in the Denver, Colorado area and I am in community practice. Kathleen Sacharian: Good morning, everybody! I'm Kathleen Sacharian, and I'm an oncology nurse practitioner. I've had over 20 years of experience in both academics setting and community practices in the Philadelphia area. Marty Clarke: Hello, everyone! I'm Marty Clarke. I'm in Tucson, Arizona. I've got closer to 30 years of practice in general medical oncology, as well as a fairly lengthy stint in cancer psychiatry. I'm also a clinical psychologist. Dr. Stephanie Williams: Thank you all. Today's episode will be a deeper dive into the specifics of what physician assistants and advanced practice registered nurses or nurse practitioners do on a day-to-day basis in an oncology practice, as well as addressing some common misconceptions of what PAs, APRNs, NPs do in practice. So, jumping right in, I'd like to ask you all to shed some light on the general differences between a physician assistant and an advanced practice registered nurse or nurse practitioner. Who would like to start? Todd Pickard: I'll get the ball rolling. This is Todd. This is a great question. It's one that people ask a lot, you know, what is the difference? And honestly, in the clinical setting, there really is no difference. When you see an advanced practice provider, whether they be an APRN or a PA, you're going to get the same kind of team-based care with quality and safety and that really focuses on the totality of the patient. PAs and NPs arrive to their clinical work from different educational perspectives. But the work we do really is the same high-quality level of care. I'll defer to my colleagues to add some to that conversation. Leslie Hinds: Yeah, I would agree with you, Todd, that in practice, NPs and PAs provide the same quality of care and the same type of care but our education and background is oftentimes different from a nursing role versus a medical role. Kathleen Sacharian: I'll add that, you know, I think when we think about some of the main differences, really focusing, as Leslie said, like how are we prepared? How are we trained? A nurse practitioner is typically a registered nurse with a bachelor's degree and then goes back for a graduate degree in either a Master of Science in Nursing or a Doctorate in Nursing Practice. And typically, some of the main educational differences in a nurse practitioner role are that their focus in education is population-based, meaning it's based on a specific patient population or health condition. So, you might have an adult gerontology nurse practitioner or a pediatric nurse practitioner. Marty Clarke: Kathleen, I have a daughter that happens to be a GYN oncology nurse practitioner. And so, her focus is a little different than mine but it's always fun when she reminds me how much smarter she is in certain areas. Dr. Stephanie Williams: Just from my standpoint as a poor old physician here, are there differences from state to state between what you guys can do? That's one question. Two, your histories are so different in terms of how you came to become PAs, how the field of PAs and how the field of nurse practitioners developed, which is, in my opinion, very fascinating. So, I wonder if there are any comments on any of those issues? Todd Pickard: Yes, Stephanie. That's a great question. I was just thinking about how really, when people see differences between APRNs and PAs, it's generally because of state law or an institutional policy. And that's what's very unique about advanced practice providers is that their practice can vary wildly from state to state, unlike physicians, who basically have one standard national type of practice. An APP in Texas looks very different than an APP in New York or Alaska or Hawaii or Mississippi. And so, you do have to be very cognizant of the fact that it is important to be aware of what each state says or what even individual institutions say. Leslie Hinds: At my institution, physician assistants are not allowed to supervise infusion, which is a big part of medical oncology. So, unfortunately, in my practice, we have nurse practitioners only and have been unable to hire PAs because of that limitation. Dr. Stephanie Williams: So, these institutional guidelines, are they based on state regulations or just based on current practices at those institutions? Kathleen Sacharian: Well, I think it's really dependent on the institutional experience, you know, there might be a large academic center that has a very well-developed advanced practice provider program compared to maybe a smaller community practice that has one nurse practitioner or PA. So, I think the experience with the individual institution or clinic, but overall, that really is dictated by the state licensure and regulations. So, that is the first thing that needs to be looked at when considering these roles and responsibilities of advanced practice providers. Todd Pickard: Stephanie, you bring up a very good point, which is whenever an institution or an individual practice takes a position, it's always good to explore the 'why'. Is this customary? Is it a habit we've been in? Or is it based simply on a misunderstanding or even a preference? Many times, when you go to explore these things, you'll find that it's either a misunderstanding or a preference. It's not because something is required that way. At my institution, for the longest time, we only hired nurse practitioners on the inpatient side, because somebody thought that PAs didn't learn how to take care of patients in the hospital. And we had to have a conversation. I said, "No, actually, when I was in PA school, I actually had to sleep in the hospital, and for 6 weeks on my inpatient medicine rotation, so that I could give care 24 hours a day." So, no, we are trained there. So, it was completely a misunderstanding. And so, I think that's why it's very important that you have advanced practice providers who are part of your leadership in your governance, so they can help you craft good practices, good policies, top of license practice so that you really maximize all the team members. Marty Clarke: All these points are really poignant. The example of PAs not being able to oversee infusions, that probably stems out of an assumption that PAs, unlike oncology nurses that then become NPs, are more qualified somehow for infusion. And it goes back, I think, to what we talked a little bit about the training, where PAs are trained in the medical model. There are assumptions that are made around that that sometimes are not correct, just as the nurses are trained under nursing theory. And there are assumptions that are made around that. In my practice, there's a belief that the nurses can't function in the hospital, which is, you know, kind of ironic to me. And I think it's an assumption based on their training and an incorrect assumption. So, again, Todd, you're right. You need leadership and an open mind to this and also, you've got to pay close attention to what the individual, you know, state laws are, but they're more similar than they are different, I would say. Dr. Stephanie Williams: Just as a for instance, guys, I practiced for several years in the state of Michigan, the law has changed now, thankfully, but I had a combination of nurse practitioners and physician assistants, and my nurse practitioner, by law, could not order a consult for physical therapy, only my physician assistants can. So, I think it gets frustrating for physicians, because then how do I know what a PA can do and what an NP can do if, you know, I go to Illinois now and I practice under a different set of state laws. When I started in my career over 30 years ago, PAs were quote, "surgical", they held retractors, they stitched people up, they did our urology consults for instance and put Foleys in. And nurse practitioners were more bedside, taking care of patients. I think some of that has changed. But I don't know if you guys have any comments, how does a physician who's in practice in the rural community, and a more cosmopolitan community and academia, how do these things differ in your daily day-to-day routines? Todd Pickard: This is a great transition, you know, Stephanie, that's a very salient point, is really to take a little bit of a deeper dive into thi

31/08/2022

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36 min
16/03/2022

Cancer Topics – Delivering Serious News (Part 2)

In the second of this two-part ASCO Education Podcast episode, Drs. Stephen Berns (University of Vermont), Tyler Johnson (Stanford Medicine), and Katie Stowers (Oregon Health & Science University) continue their discussion about what it takes to deliver serious news to people with cancer effectively and compassionately. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org. TRANSCRIPT [MUSIC PLAYING] STEVE BURNS: Hello, and welcome to the second part of ASCO's Education Podcast focused on clinician-patient communication in the context of delivering serious news to patients and families. My name is Steve Burns. I'm an internist, hospice, and palliative care physician and associate professor of medicine at the University of Vermont College of Medicine. Once again, I'm joined by Katie Stowers, a hospice and palliative care physician and assistant professor of medicine at the Oregon Health Science University, and Tyler Johnson, a medical oncologist and clinical assistant professor of medicine at Stanford University. In our previous episode, we spoke about what constitutes serious news, the best modalities for delivering serious news particularly in the wake of COVID, who might be the best person to deliver it, and the importance of the care team as a whole. We left off on the question, how do we prepare for delivering serious news? Let's continue the conversation. [MUSIC PLAYING] TYLER JOHNSON: Katie was talking about how we need to be realistic about the way that a conversation is going to impact us in addition to the way that it's going to impact the patient. And one thing that I have realized is that a headline, for those who maybe haven't had evals of training, is just a concise summary statement of sort of the big picture of what's going on, just like buying a newspaper article. And what I have recognized is that oftentimes, I have this almost visceral reaction against giving a headline. And if I drill down just a little bit, what I find is I don't want to give the headline because then I'm really going to have to say things the way that they are, right? If I give a five minute disquisition on creatinine and edema and chemotherapy, immunotherapy, therapeutic options and whatever, right? Then, I can just like talk a cloud around things and never actually say what it is that I'm trying to say, which then gives me the advantage of feeling like I said it, but actually sort of knowing that I never actually said it, right? And so I think the thing that the headline does is it forces me to say the thing. And then once the thing is out in the open, then we can talk about, if necessary and appropriate, some of the other nuances and whatever. But all of that is to say that often, the greatest barrier to doing that is an unwillingness to be real with myself about the information that I'm really trying to convey. KATIE STOWERS: I think this is another really great opportunity where when partners go in together, it's easier to get into the moment if you get the opportunity. Someone with a little bit of accountability, but also somebody to help you. Maybe you're able to get out the facts and they're able to tie-in the meaning. Or you end up going bigger than your headline and they're able to say, I think what you were trying to say was dah-dah-dah-dah-dah, and help really get back to that core. STEVE BURNS: It does say that we all, before we share serious news, making sure whoever you're going in with, you're on the same page. And having a pre-meeting is so important. And what I often do with my pre-meetings is I come up with the headline as the group, right? So we're all clear about what is that headline so that when we go in, we can, in some ways, also hold each other accountable for that headline. KATIE STOWERS: I think also, a little bit of who's going to say it too. Like, is that something that you feel comfortable saying, or would it be easier for somebody else to say? Are there parts of it, and then parts of it that I can do, I think, can be really helpful. TYLER JOHNSON: Yeah. It's funny, because sometimes, even though I'm pretty tuned into these things and I try really hard to do them well, I still find that there are times as a medical oncologist when the palliative care doctor who is unfailingly ever so nice and gracious about it, ends up being like the real human translator for my medical leads. So I, like, say some word cloud. And then the palliative care doctor, like Katie just said, is like, if I can say that what Dr. Johnson was trying to say right there is something in normal human English speak. And then, as soon as they do that, I'm like, oh. But that can actually be really helpful. And again, I think it's obviously not meant to slight me. It's not meant as an affront, right? It's just sometimes, it's just kind of hard to quite get there, right, and to quite say the thing. And sometimes, having someone to help. Like, you get 80% of the way there, and then having somebody else get the other 20% is really, really meaningful. And it also, in a strange way, kind of allows us to share the emotional burden a little bit, right? So that it doesn't feel like, oh my gosh, this is just me saying this thing. There's something about having other members of the team there to kind of hold your arms up as you're doing that that's really meaningful. KATIE STOWERS: I worry that part of this conversation is saying like, oh. Some people are really good at this. Some people aren't. I don't think that this is a palliative care physician's good the whole time. I think this is a normal human experience. This just happened to me. This week in clinic where my patient was like, you just told me like a five minute story of things I already know. And I still don't know any more information. And I was like, oh, that wasn't really clear at all, was it? So I mean, I think it's when our nerves pop up. When we are uncertain or unclear about what it is that we want to say or just really nervous about doing it, like, I think this is our normal human default to go back to beating around the bush. But it definitely, as Steve mentioned, is a skill that we can learn and continue to practice. And it's also really helpful to have somebody there who can hold your feet to the fire and help you in the moment. STEVE BURNS: Katie, I'm so glad you mentioned that. I just think about even for us as palliative care physicians, who do serious illness conversations all the time, catching ourselves doing some things because we are being affected by the conversation and our well-being. I remember a couple of weeks ago, how hard it was for me to say dying and death. And I know. I've been teaching my learners say the D word. It's OK. It's direct. It's straightforward. And then all of a sudden, I was in the middle of the conversation and I noticed I was struggling saying death. And so again, just to say we are human, that these conversations affect us. And having team support is so helpful in the moment. Because the chaplain who I was with said, what we're saying is we're worried that she's dying. And I was like, oh thank god. She said it. TYLER JOHNSON: And the other thing too, right, is that I think it's helpful in a sense to recognize that the difficulty with giving a headline or with saying death or dying or whatever is an impulse borne of human compassion. I mean, it's not because we're bad people. It's because we have good hearts and because short of maybe clergy members, there's really nobody else in the way that human ecosystems are set up that does this, right? It's just a hard thing to do. And recognizing that it's hard and recognizing that we ourselves are having a hard time with it, is not some failing of doctoring. I would say that actually, this is one of those weird instances where having that consistent struggle, that should be a tension that should define part of how we doctor. Because if the tension goes away, that's actually more worrisome than if the tension continues to be there, though we have to find productive ways to engage with it. STEVE BURNS: Yeah. We did a study in 2016, the Vermont Hospice Study, and similar to actually, what Cambia Health Foundation found, why people don't engage in serious illness conversations. And one of the biggest reasons was taking away hope or hurting people's feelings and in causing emotional distress. We also know with the literature that most patients, up to like 90%, 95%, want to know the truth because it helps them better make decisions. And I think we can deliver prognosis in a compassionate way. And I think practicing that in the kind and caring way that's person-centered, asking them, what do you know? Is it all right if we talk about this right now? Delivering in a headline and responding to emotion can help make that a more compassionate conversation. Although it still doesn't take away the human feeling that I'm worried I'm going to hurt someone in this conversation. TYLER JOHNSON: Almost always in my experience, patients who have metastatic disease, or for some other reason, disease that is known from the get-go to be incurable, in one of our first discussions, they will ask some version of the question of how long do I have, or what are things going to look like going down the road? There's good evidence to demonstrate, and it has also been my personal experience, that we're really bad at answering that question at the time of diagnosis, right? Because we don't know anything about the biology of the tumor, the response of chemotherapy, what the molecular markers are. There's a whole host of things that just make it so we almost always cannot answer the question accurately even if we try. And so what I will usually do is I will tell patients, I'll say, when they ask some version of that question, I'll say, look. I need you to know that, first of all, I can't answer that question right now

16/03/2022

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27 min
19/07/2021

Management of the Axilla in Early-Stage Breast Cancer: OH (CCO) and ASCO Guideline

An interview with Dr. Muriel Brackstone from London Health Sciences Centre and Dr. Tari King from Dana Farber and Brigham and Women's Cancer Center, authors on "Management of the Axilla in Early-Stage Breast Cancer: OH (CCO) and ASCO Guideline." This guideline addresses management & timing of surgical and radiotherapeutic treatment of the axilla in early breast cancer. Read the guideline at asco.org/breast-cancer-guidelines. Suggest a topic for guideline development at surveymonkey.com/r/ascoguidelinesurvey. TRANSCRIPT [MUSIC PLAYING] SPEAKER: 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. [MUSIC PLAYING] BRITTANY HARVEY: Hello, and welcome to the ASCO Guidelines podcast series, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all the shows, including this one, at podcast.asco.org. My name is Brittany Harvey, and today I am interviewing Dr. Muriel Brackstone from London Health Sciences Center in London, Ontario and Dr. Tari King from Dana-Farber and Brigham and Women's Cancer Center in Boston, Massachusetts, authors on "Management of the Axilla in Early-Stage Breast Cancer" Ontario Health (Cancer Care Ontario) and American Society of Clinical Oncology Guideline." Thank you for being here Dr. Brackstone and Dr. King. DR. MURIEL BRACKSTONE: Thank you. DR. TARI KING: Thank you for having us. BRITTANY HARVEY: First, I'd like to note that we take great care in the development of our guidelines in both the ASCO and Ontario Health Cancer Care Ontario program and evidence-based care. Conflict of interest policies were followed for this guideline. The full conflict of interest information for this guideline panel is available online with the publication of the guideline in the Journal of Clinical Oncology. Dr. Brackstone, do you have any relevant disclosures that are directly related to this guideline topic? DR. MURIEL BRACKSTONE: No, I don't have any conflicts to disclose. BRITTANY HARVEY: Thank you. And Dr. King, do you have any relevant disclosures that are directly related to this guideline topic? DR. TARI KING: No, I do not have any relevant disclosures. BRITTANY HARVEY: Great, thank you. Then let's get into some of the content of this guideline. So first, Dr. Brackstone, can you give us a general overview of what this guideline covers? DR. MURIEL BRACKSTONE: Sure. This guideline reviews how best to diagnose and treat any lymph node spread in breast cancer patients with early-stage disease. It also reviews the role of radiation and surgery in treating the axilla to reduce the risk of regional cancer recurrence in these patients. BRITTANY HARVEY: Great, thank you. Then I'd like to review some of the key recommendations that this guideline covers. So this guideline addresses five specific objectives. So I'd like it if we could go through each of those. So for each of these objectives, could you give an overview of those high level recommendations? First, Dr. King, the first objective is about which patients with early-stage breast cancer require auxiliary staging. DR. TARI KING: Yes, thank you. So I think the two main takeaway points from this objective-- the first is that sentinel lymph node biopsy really is the standard of care for axillary staging for all breast cancer patients when it is felt that information about the lymph node status is necessary. So this really is in the majority of patients that we see and care for with early-stage breast cancer. We want to know the status of the axillary lymph nodes. That's important in our subsequent treatment recommendations. And there's really no role for axillary lymph node dissection as a staging procedure any longer. Sentinel lymph node biopsy is the staging procedure of choice. Now, there are some patient populations, however, where we may decide that we don't need the information from the axillary lymph nodes to make subsequent treatment recommendations. And one particular group which is called out in this guideline is for those women who are over the age of 70 with early-stage, again, clinically node-negative hormone receptor-positive, HER2-negative breast cancer, where the information from the sentinel lymph node biopsy is not going to alter subsequent systemic therapy recommendations. And this is really based on several lines of work demonstrating that omitting sentinel node in these older women, again, with hormone receptor-positive, HER2-negative breast cancer, does not negatively impact their long term outcomes. And so this is an opportunity for us to tailor our approach to a particular patient population without having a negative impact. BRITTANY HARVEY: Great, thank you, and thank you for reviewing for which patients this is specifically targeted to. So then for the second objective, Dr. Brackstone, is further auxiliary treatment indicated for women with early-stage breast cancer who did not receive neoadjuvant chemotherapy and are sentinel lymph node-negative at diagnosis? DR. MURIEL BRACKSTONE: No. We use this guideline to confirm that in patients who have early-stage disease and go to surgery first, so they're not having neoadjuvant chemotherapy. And in those patients, if their sentinel lymph node excision for staging is negative, that no further axillary surgery is required. Now, with regards to axillary radiation, it may be considered in the subset of patients whose breast cancer risk is high for recurrence-- so the triple negative subtype, patients who are under 50 years of age, or those with medial tumors. BRITTANY HARVEY: OK. And then Dr. King, for the third objective, which axillary strategy is indicated for women with early-stage breast cancer who did not receive neoadjuvant chemotherapy and are pathologically sentinel lymph node-positive at diagnosis after a clinically known negative presentation? DR. TARI KING: Thank you. Yes, so this recommendation really addresses a very large population of our breast cancer patients. Those that present with clinical T1 and T2 but node-negative early-stage breast cancer, we take them to the operating room. We perform a sentinel biopsy, and about 20% to 30% of them will actually end up having positive lymph nodes. And traditionally, we thought that we needed to do axillary lymph node dissection in the setting of positive nodes. But we now have multiple clinical trials that have addressed this question. And we now know that it is safe to avoid lymph node dissection in women found to have one or two positive sentinel nodes. We've had trials that have compared lymph node dissection to axillary radiotherapy or lymph node dissection to observation alone. And with either of those strategies, we've seen excellent local control in the women who have not undergone lymph node dissection. And so it really provides us, again, an opportunity to dial back or tailor our therapies to the patient's individual disease burden. Now, certainly, patients that have more than one or two positive nodes, and the guideline specifically states how to manage patients with three or more positive nodes. And those patients do need additional axillary treatment, either in the form of lymph node dissection or lymph node dissection plus axillary radiotherapy and in some scenarios. Also, the guideline is very clear to define that there are some differences in the level of recommendation for women undergoing breast-conserving surgery and found to have one or two positive nodes as opposed to women undergoing mastectomy and found to have positive nodes. So certainly, we have the larger body of data in the breast-conserving therapy group, but the guideline is very clear to also highlight the data that is available for the mastectomy group. And again, the overall recommendation is that not everybody with positive nodes needs additional lymph node dissection. And that we have alternatives which we know minimize the morbidity of our treatments. BRITTANY HARVEY: Great. Thank you for addressing the evidence base behind both of those recommendations as well. So following that, Dr. Brackstone, for the fourth objective, what axillary treatment is indicated? And what is the best timing of axillary treatment for women with early-stage breast cancer? And when is neoadjuvant chemotherapy used? DR. MURIEL BRACKSTONE: Right. So this guideline was really used to formalize a recommendation against repeating the sentinel lymph node biopsy procedure twice in patients, before and after chemotherapy. We really found that the risk of false negativity in a repeat procedure was too high. So for patients who are having neoadjuvant chemotherapy-- so patients with higher risk cancers-- the axillary ultrasound is useful to guide a biopsy of any suspicious lymph nodes to document if they're positive. If the clinical exam and the ultrasound are both negative, then the sentinel lymph node excision should be done at the time of surgery after chemotherapy. If they do have a positive lymph node that's confirmed by biopsy before their chemotherapy, and those lymph nodes respond really well to chemotherapy and are no longer palpable, then their staging can occur by sentinel lymph node procedure at the time of surgery. And that avoids what we have standardly done up to now, which is the axillary dissection and the risk of lymphedema that comes with that. If the sentinel lymph nodes are negative when you're doing your surgery after neoadjuvant chemotherapy, then we are recommending that no axillary lymph node dissection is required. If any of the lymp

19/07/2021

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13 min
01/03/2020

High Reward, High Toxicity: Combination Pembrolizumab and Lenvatinib in Advanced Endometrial Cancer

The combination of pembrolizumab and lenvatinib is a promising second line option for metastatic or recurrent MSS endometrial cancer, although there can be considerable toxicity and choosing appropriate patients is key. TRANSCRIPT This JCO Podcast provides observations and commentary on the JCO article "Lenvatinib and Pembrolizumab in Patients With Advanced Endometrial Cancer" by Makker et al. My name is Meghan Shea, and I am an Instructor of Medicine at Harvard Medical School at Beth Israel Deaconess Medical Center in Boston, Massachusetts. My oncologic specialty is gynecologic oncology. Patients with advanced endometrial carcinoma have limited options after receiving the carboplatin and paclitaxel doublet for recurrent or metastatic disease. The study that accompanies this podcast evaluates the combination pembrolizumab and lenvatinib, providing a much needed second-line option for this patient population. The approval of single-agent pembrolizumab for tumors with microsatellite instability (from here on referred to as MSI high) does not have immediate relevance for the majority of patients with advanced endometrial carcinoma who have microsatellite stable disease (from here on referred to as MSS). Makker et al. now report the results of an ongoing phase 1b/2 study of pembrolizumab, an anti-PD1 antibody, and lenvatinib, an oral tyrosine kinase inhibitor that targets the VEGF-receptor, in patients with metastatic endometrial carcinoma. Eligibility criteria included patients with an ECOG 0 to 1 who had confirmed metastatic disease with less than or equal to 2 prior lines of systemic therapy. Notably the majority were not heavily pre-treated; 52.8% of patients in the study had only one prior line of systemic treatment. Patients received lenvatinib 20 mg once daily orally continuously and pembrolizumab 200 mg intravenously every 3 weeks – with a maximum duration of 2 years for pembrolizumab. All patients had imaging at baseline and then every 6 weeks for first 24 weeks and then every 9 weeks thereafter. The primary end point was objective response rate at 24 weeks. Forty-one of the 108 patients, 38%, had a response at 24 weeks with a median follow up of 18.7 months. As expected, the MSI high tumors had a higher response rate of 63.6%, although this was a minority of the study population, only 11 patients. Most importantly, the patients with MSS tumors had a response rate of 37.2% with a median duration of response of 21.2 months. The histology did not appear to impact the response rate – the majority of patients had endometrioid (50.9%), although the study population also contained a reasonable proportion of serous and clear cell (38%) compared to the expected frequency in the general population of advanced uterine cancers. The PD-L1 status positive or negative did not correlate with response. One might question, before accepting a complicated regimen with both oral and IV chemotherapy as a new second-line standard option, whether anyone has studied the activity of either single agent lenvatinib or single agent pembolizumab in a similar population, especially for those with MSS disease. With the caveats of cross study comparisons, it appears that neither single agent is as active as the current combination. For instance, Vergote et al reported results of a phase 2 study of lenvatinib monotherapy for advanced endometrial cancer, where the response rate was only 14.3% with median progression free survival of 5.4 months. Likewise, Ott et al studied single agent pembrolizumab in endometrial cancer with 18 of 19 patients having MSS cancer, resulting in only a 13% response rate and progression free survival of 1.8 months. So you may be wondering, what's the catch? The issue is the potential toxicity of this doublet regimen, with 66.9% or 83 of 108 patients, having a grade 3 or 4 treatment-related adverse event. Overall 17.7% of the patients discontinued one or both drugs. Notably, pembrolizumab was never dose reduced - only dose held or discontinued. Most strikingly, 62.9%, roughly two thirds of patients, required a dose reduction of lenvatinib. Only 11 patients (that is 8.9%) stayed on full dose 20 mg of lenvatinib for greater than 6 months. The average dose for lenvatinib was 14.4 mg daily. The toxicity profile of lenvatinib may be related to the fact that it is a multi-targeted tyrosine kinase inhibitor that targets not only vascular endothelial growth factor receptors, but also fibroblast growth factor receptors, platelet-derived growth factor receptor alpha, RET and KIT. There were 51 deaths during this study; the majority occurred during follow up due to progression of disease. However, there were 16 deaths while on study, 4 considered treatment emergent adverse events and 2 judged to be treatment related. The four deemed treatment emergent were due to gastrointestinal perforation, intestinal obstruction, general health deterioration and metabolic encephalopathy. The two deemed treatment related were from septic shock and intracranial hemorrhage. The National Comprehensive Cancer Network (NCCN) guidelines have added the combination of pembrolizumab and lenvatinib to their list of second line therapeutic options, and it also has been approved by the Food and Drug Administration (FDA). This recognizes the fact that this combination has the highest response rate of the available drugs listed, and thus should be a strong consideration for second line therapy for patients with MSS endometrial carcinoma. However, ensuring that this treatment is appropriate for a given patient is of the utmost importance. First the patient must be a candidate for immunotherapy – ideally not on chronic prednisone and/or have an active autoimmune disease. In contrast to prescribing single agent anti-PD-1 or anti-PD-L1, a performance status of 0 to 1 is important with this combination. The most appropriate patient should have controlled blood pressure prior to initiating drug, be able to monitor their blood pressures, take their oral chemotherapy as prescribed, and readily report any new symptoms. I avoid prescribing this drug combination if the patient has a bleeding disorder, recent clotting, uncontrolled hypertension, or is at high risk of a fistula or bowel obstruction. Lenvatinib is a renally-cleared drug, and thus patients with a reduced glomerular filtration rate (GFR) require renal dosing. This is especially relevant for patients with recurrent uterine cancer, whose kidney function is dynamic, especially in the setting of hydronephrosis. In my practice, I consider starting patients with normal renal function at 14 mg lenvatinib daily, given that the vast majority of patients on study were eventually dose-reduced. Furthermore, I might start the lenvatinib dosing even lower for patients with dynamic renal function and for those who have a baseline GFR lower than 30. Overall this study provides a promising second line option for metastatic or recurrent MSS endometrial cancer, with responders having a durable response. Patient selection and dose adjustments are key considerations to avoiding and managing toxicity. This concludes this JCO Podcast. Thank you for listening.

01/03/2020

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8 min
19/09/2022

Integrative Medicine for Pain Management in Oncology: SIO-ASCO Guideline

An interview with Dr. Jun Mao from Memorial Sloan Kettering Cancer Center in New York, NY, lead author on "Integrative Medicine for Pain Management in Oncology: SIO-ASCO Guideline." Dr. Mao reviews the recommendations on integrative approaches, such as acupuncture, yoga, reflexology, massage, guided imagery with progressive muscle relaxation, hypnosis, and music therapy for managing pain in patients with cancer, and the evidence behind these recommendations. He also addresses the implications for clinicians and patients as well as outstanding questions about the use of integrative approaches for pain management. Read the full guideline at www.asco.org/survivorship-guidelines. TRANSCRIPT Brittany Harvey: Hello, and welcome to the ASCO Guidelines podcast series brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all the shows, including this one, at asco.org/podcast. My name is Brittany Harvey, and today I'm interviewing Dr. Jun Mao from Memorial Sloan Kettering Cancer Center in New York, New York, lead author on 'Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology and American Society of Clinical Oncology Guideline'. Thank you for being here, Dr. Mao. Dr. Jun Mao: Thank you, Brittany. It's great to be here. Brittany Harvey: First, 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 full conflict of interest information for this guideline panel is available in line with the publication of the guideline in the Journal of Clinical Oncology. Dr. Mao, do you have any relevant disclosures that are directly related to this guideline topic? Dr. Jun Mao: No, I don't. Brittany Harvey: Great. Then I'd like to get into the content of this guideline. So what is the purpose and scope of this joint SIO-ASCO guideline? Dr. Jun Mao: So Brittany, about one in two cancer patients or survivors experience pain that often are not adequately controlled by conventional medications. So often individuals seek out complementary and alternative medicine, more recently known as integrative medicine, for the relief of pain, but there's a very little synthesized information for oncologists to help guide the patients in choosing evidence-based integrative therapy approach. Therefore, we decided to really do a systematic review and come up with a system of guidelines that can help oncologists and patients make informed decisions about choosing the right type of integrative medicine approaches to manage pain. The Society for Integrative Oncology and the American Society of Clinical Oncology joined forces that really convene a group of panelists, that represent many fields in conventional oncology in support of integrative medicine. And after reviewing over 200 articles from clinical trials to systematic review have come up with very thoughtful recommendations to help patients and physicians to provide the best evidence-based care on how to manage pain for patients with cancer. Brittany Harvey: Excellent. And yes, it's great to have SIO and ASCO join forces on this guideline. So then next, I'd like to review those key evidence-based recommendations of this guideline that you just mentioned. The recommendations are provided in the guideline by pain type. So I'd like to review each category for our listeners, starting with: what is recommended for patients experiencing aromatase inhibitor related joint pain? Dr. Jun Mao: So we recommend acupuncture should be offered to patients experiencing aromatase inhibitors related joint pain in breast cancer. And this is really evidence-based, benefits outweigh the harms. And with intermediate quality of evidence and moderate strength of recommendation. As many of our audience would know, aromatase inhibitors cause very severe types of joint pain that not only affect quality of life and functions, but make many women stop taking these life saving drugs. So the panelists want to recommend this therapy based on large randomized control trial that hope this can be part of a pain management strategy along with exercise and duloxetine so give people the options so that women can not only have better quality of life, but also hopefully they can stay on aromatase inhibitor to prevent the recurrence of breast cancer. And we also found some weak evidence for yoga to improve joint pain related to AIs. However, the evidence is weak, although the benefit outweighs the harm. So clearly, more studies are needed to make yoga as a part of therapies for cancer patients. Brittany Harvey: Understood. And thank you for reviewing the level of evidence behind those two interventions for patients experiencing aromatase inhibitor related joint pain. So following those recommendations, what is recommended for patients experiencing general cancer pain or musculoskeletal pain? Dr. Jun Mao: So in terms of general cancer pain or musculoskeletal pain, there are three therapies that we consider that may be offered to patients experiencing this type of pain: acupuncture, reflexology or acupressure, or massage. So reflexology and acupressure use the same kind of principles like acupuncture, but instead of using needles, by using hands. So that's kind of in between acupuncture and massage. So these are evidence based recommendations with benefits outweigh harms, and the quality of evidence is intermediate with moderate level of evidence and recommendations. So clearly, for cancer patients or survivors that experience this type of general cancer pain or musculoskeletal pain, I think these approaches may be appropriately integrated along with conventional pharmacotherapy or physical therapy. Brittany Harvey: Definitely. It's great to have options to go along with conventional pharmacologic therapy. So then following those recommendations you just mentioned, what is recommended for patients with chemotherapy-induced peripheral neuropathy? Dr. Jun Mao: So chemotherapy-induced peripheral neuropathy, also known as CIPN, is a very bothersome symptom resulting from certain types of chemotherapy that can be very functional limiting, and resulting in falls and that also can cut the dosage of chemotherapy. So this is a quite bothersome to patients and also can be really challenging in the practice of oncology. So based on the current evidence, we recommend either acupuncture or reflexology or acupressure may be offered to patients who experience CIPM. So, unfortunately, the evidence base here is weaker. So although it's evidence-based, benefits outweigh harms, but the quality of evidence is low. Therefore, the level recommendation is weak. So basically, there are a number of smaller trials that really provide some good signals that this type of therapies can be beneficial. But we really need more large and definitive trials to establish the strength of the evidence Brittany Harvey: Understood. It's important to know in which patient populations we have more evidence and where we still need confirmatory results. So following those recommendations, what is recommended for patients who experience procedural or surgical pain? Dr. Jun Mao: Many surgery procedures or surgery itself can cause acute short-term pain that if not adequately treated, can then become chronic. So in this setting, there is actually a pretty reasonably robust base for hypnosis. So the evidence base really is intermediate with moderate level recommendation. We consider that hypnosis may be offered to patients experiencing procedural pain in cancer treatment or diagnostic workups. However, for other type of therapies like acupuncture or acupressure or music therapy, although there are some smaller trials to show that it could be beneficial, the current evidence base is very low and the strength of recommendation is weak. So clearly, we need more high-quality trials to establish the evidence base for those therapies for surgery or procedure-related pain Brittany Harvey: Understood, and we'll get into some of those outstanding questions or where there's insufficient evidence a little bit later in the episode. So then the last category of recommendations that the panel made: what is recommended for patients who have pain during palliative and hospice care? Dr. Jun Mao: So for patients with advanced cancer near the end of life, there is some good evidence that massage may be offered for patients experiencing pain during palliative and hospice care. So we recommend massage should be used with an intermediate level of evidence and moderate level of recommendation. And I do think the caveat is we still don't know the long-term effects for massage. Therefore, many of the trials, the follow up are reasonably short. But the evidence showing that acupuncture in the population of palliative care hospice patients can produce immediate pain relief as well as to enhance coping. Therefore, we suggest massage may be offered to patients experiencing pain during hospice or palliative care settings. Brittany Harvey: Understood. Well, thank you for reviewing all those recommendations, the level of evidence behind them and the strength of those recommendations. But you've also mentioned that in several areas, there's low evidence or insufficient evidence. So are there interventions that the panel reviewed but found insufficient or inconclusive evidence to make recommendations? Dr. Jun Mao: Brittany, I feel like the field of integrative medicines research is still in its infancy or adolescence. So there's clearly a lot of gaps, particularly in the area of mindfulness-based interventions. There are studies showing outside oncology settings, it can be very helpful for managing pain and pain coping, but that literature in oncology is very, very limited to make any reasonable rec

19/09/2022

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18 min
26/10/2023

Outcomes of the IMMray PanCan-d Test in High-Risk Individuals

JCO PO author Dr. Bryson Katona shares insights into his JCO PO article, "Outcomes of the IMMray PanCan-dTM test in High-Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned." Host Dr. Rafeh Naqash and Dr. Katona discuss IMMray PanCan-d: A Blood-based Test for Early Detection of Pancreatic Cancer. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO Precision Oncology articles. I'm your host, Dr. Rafeh Naqash, Social Media Editor for JCO Precision Oncology and Assistant Professor at the OU Stephenson Cancer Center. Today, we are thrilled to be joined by Dr. Bryson Katona, Director of Gastrointestinal Cancer Genetics Program and Assistant Professor of Medicine at University of Pennsylvania Abramson Cancer Center, and also lead author of the JCO Precision Oncology article, "Outcomes of the IMMray PanCan-d tm Test in High Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned." At the time of this recording, our guest disclosures will be linked in the transcript. One of the other unique things about this article is that this will be a concurrent podium presentation at the 2023 CGA-IDC Meeting and also concurrent publication in JCO Precision Oncology. Bryson, welcome to our podcast and thank you for joining us today. Dr. Bryson Katona: Thank you so much for the invitation and I'm looking forward to discussing the findings of our recent study. Dr. Rafeh Naqash: So, one of the unique things about this topic or this publication is surveillance, which we often talk about a lot in lung cancer, breast cancer, colorectal cancer, but not so much in pancreas cancer. For a listener who might be a community oncologist or for a trainee out there, fellow, who may not be as specialized in cancer genetics, what are the kinds of individuals that you would screen for pancreatic cancer? What are the high risk populations where there's a decent pretest probability that you could catch something early? And what are the implications of catching something early in people with pancreas cancer? Dr. Bryson Katona: The whole field of pancreatic cancer screening and high risk individuals, which we'll refer to as pancreatic surveillance, has just been an area of increasing growth and increasing data over the last five years or so. For individuals that we would consider pancreatic cancer surveillance in, really, we try to target those individuals that have a lifetime risk of pancreatic cancer of about 5% or more. And so those fall in two main groups. So one of those groups are individuals that would have what we would define as familial pancreatic cancer. That's where there's a very strong family history of pancreatic cancer without a known genetic susceptibility. And so by strong family history, what we typically refer to is having two members of that family with pancreatic cancer. And those two members of the family have to be directly related to one another, and your patient would then have to be directly related to one of those individuals. So, say your patient has a father and a brother or a mother and a maternal grandfather. Those would kind of fit the criteria. The other big group of patients that we consider doing pancreatic cancer surveillance in are those with genetic susceptibility to pancreatic cancer. And this can come in multiple different forms. Some more of the common cancer risk syndromes, such as Lynch Syndrome, and carriers of a BRCA1 or BRCA2 mutation. Typically in the presence of one family member with pancreatic cancer, those individuals could be eligible for surveillance. But there are other rarer syndromes as well, such as carriers of an ATM or PALB2 mutation, individuals with Peutz-Jeghers syndrome or hereditary pancreatitis as well. Dr. Rafeh Naqash: My understanding of these mutations is they have to be germline in these individuals. Could you shed a little more light on germline mutations, what they are, how potentially to recognize them? Because in the current setup, at least, most patients with advanced cancer get next generation sequencing, which is not the same as germline testing. So, for somebody who sees these reports, I do early phase clinical trials primarily and do a lot of sequencing, and find a lot of interesting things which lead to germline testing in individuals, could you shed some light on the differences between NGS testing and germline testing, since you do this day in and day out? And in what scenarios would you test for germline things that could lead to downstream implications for individuals? Dr. Bryson Katona: Oftentimes, this is a point of some confusion or uncertainty. And so when we think about germline testing, basically we're looking for gene mutations that are going to be present in every cell throughout the body. When patients who have a tumor undergo somatic sequencing of that tumor, of course, we expect to find lots of gene mutations in the cancer itself. But then, typically, if there is a mutation in all cells in the body or i.e., a germline mutation, that mutation will oftentimes be picked up in the cancer as well. And so I think when you're looking at somatic sequencing reports, sometimes some of these mutations that you see in there in cancer predisposition genes may not be a cancer specific gene mutation, but may be germline and may merit kind of more additional testing. That's always one way that we can identify individuals that if one of these gene mutations is picked up on the somatic sequencing, they can get referred. Now, if we think about the population who may not have cancer yet but may have a strong family history, in those cases, those individuals are typically getting referred directly for germline testing since they don't have any tumor or anything like that that has been tested. So that also is another opportunity where, ideally, we would identify all these gene mutations in the ideal world just because we, of course, like to know about these before an individual actually does develop any cancer. Dr. Rafeh Naqash: I think the important point you brought out is doing this before the individual develops cancer is a huge opportunity for us in the cancer field to improve outcomes for certain cancers. As you pointed out in your paper, like pancreas cancer, survival outcomes in the later stages are not that great, and we haven't had any significant breakthroughs in treatments. Could you tell us a little bit more about how pancreas cancer screening could help change some of those aspects where you could see an opportunity where individuals who get screened timely, diagnosed timely, could also benefit in the long term? Dr. Bryson Katona: For pancreatic cancer, really, we know that if it can be detected at stage 1, that's really our only opportunity to meaningfully intervene and impact survival. And so when we talk about screening for pancreas cancer, basically our goal is that we either want to find very high risk lesions that are almost at the stage of cancer, or potentially stage 1 pancreatic adenocarcinomas. We know that for stage 1 disease, especially stage 1a, a five year survival is over 80%. And once you get to stage 2 disease, the five-year survival decreases dramatically. And so I think that if we're going to screen patients, really, our goal should be to detect these cancers at stage 1, where there's an opportunity for surgical intervention. Even stage 2 pancreatic cancers or any that are not surgically resectable, our ability to cure these patients essentially evaporates, and so really, screening should be done to detect things at a time when we can surgically intervene. Dr. Rafeh Naqash: In your program, from a practical standpoint at UPenn, is it the cancer geneticist, or is it the medical oncologist who makes the referral and determines need? Or how do you go about it so that other programs or individuals who might be listening to it would understand how a screening program for pancreas cancer actually works? Dr. Bryson Katona: I pretty much serve as the referral point for all of our pancreatic cancer early detection studies. We have a great collaborative group here and a lot of our oncologists who may be following these carriers with genetic susceptibility, oftentimes, if the patient is very convinced and wanting to go forward with screening, the oncologist will just order the screening tests themselves, and then me and my team will enroll individuals in studies once they come in for screening. So patients who are interested in screening oftentimes will come in for a full office appointment to really discuss the pros and the cons of screening and decide if this is something that they want to pursue themselves. Regardless of how patients get into the process, whether they get directly referred from oncologists or they come through our high risk pancreatic clinic through which I see patients, it's important that these individuals be offered the opportunity to enroll in pancreatic cancer early detection studies as really capturing data on all individuals who are getting screened is really our only hope of continuing to move this field forward. Dr. Rafeh Naqash: I totally agree, and I think, as you mentioned in the manuscript, EUS, MRIs are decent tests, but nevertheless, one is invasive, the other one is probably not cheap, may not even be available outside of North America to a large extent. So you definitely need something that's easy, less invasive, perhaps can be implemented in a broader scale. Now, from a payer standpoint in the current landscape, do payers actually reimburse for pancreas cancer screening? Is that something that is easy to come by, or do you actually end up requiring, like, peer to peer prior auth, which is something that has become a theme, an unfortunate theme in the oncology

26/10/2023

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30 min
03/12/2012

Management of Metastases to the Brain: A Therapeutic Conundrum

Whole-brain radiation therapy of metastases to the brain is not innocuous - it is associated with decrements in health-related quality of life. It is still unknown if the potential benefits outweigh the impact of the side effects.

03/12/2012

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10 min
19/12/2022

Therapy for Stage IV NSCLC With Driver Alterations: ASCO Living Guideline Update 2022.2 Part 2

Dr. Dwight Owen presents the first update to the ASCO living guideline on stage IV NSCLC with driver alterations. He identifies the latest trials that informed this update, and the updated evidence-based options for second- or later-line therapies for patients with advanced non-small cell lung cancer and an activating HER2 mutation or a KRAS-G12C mutation. Additionally, he provides important context on the reported toxicities associated with these therapeutics. Read the update, "Therapy for Stage IV Non–Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2022.2" and view all recommendations at www.asco.org/living-guidelines. Listen to Part 1 for recommendations for patients with stage IV NSCLC without driver alterations. TRANSCRIPT Brittany Harvey: Hello, and welcome to the ASCO Guidelines podcast series, brought to you by the ASCO Podcast Network; a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all the shows, including this one, at: asco.org/podcasts. My name is Brittany Harvey, and in our last episode, we addressed the living guideline updates for 'Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations.' Today, Dr. Dwight Owen from Ohio State University in Columbus, Ohio, is joining us again to discuss the updates for therapy for stage IV non-small cell lung cancer with driver alterations, as the lead author on, 'Therapy for Stage IV Non–Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, version 2022.2.' Thank you for being here, Dr. Owen. Dr. Dwight Owen: Thanks for having me. Brittany Harvey: First, I'd like to note the 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 full Conflict of Interest information for this guideline panel is available online with the publication of the guideline in the Journal of Clinical Oncology. Dr. Owen, do you have any relevant disclosures that are directly related to this guideline topic? Dr. Dwight Owen: Yeah, thanks for asking that really important question. My institution has received research funding for me to conduct clinical trials from Merck, BMS, Pfizer, and Genentech and Palobiofarma. I have no employment, stocks, stock options, or other disclosures to declare. Brittany Harvey: Thank you for those disclosures. Then getting into the content of this update, this is the first update to the living clinical practice guideline for systemic therapy for patients with stage IV non-small-cell lung cancer with driver alterations. What new studies were reviewed by the panel to prompt an update to this guideline? Dr. Dwight Owen: Thanks for that question. This is a particularly exciting update because as we were preparing for this update, reviewing two manuscripts that we think offer new options for our patients with driver alterations, there were actually updated presentations at a recent meeting that showed us even more data for these targets. So, it's really an ongoing and dynamic place. So, we really focused on two updates; one was for KRAS-G12C alterations, and then one was for HER2 alteration-positive non-small cell lung cancer. So, I'll take them one at a time; for KRAS-G12C, we included an updated recommendation based on the CodeBreak 100 study - this was a multi-center, single group, open-label, phase II study of sotorasib, which is a KRAS-G12C inhibitor, in patients with non-small cell lung cancer positive for KRAS-G12C, who had received prior systemic therapy that could either be with chemotherapy or immune therapy, and the majority of patients had received both. 124 patients were evaluable for response, and the objective response rate was 37%, with the impressive median overall survival of over 12 months, of 12.5 months, specifically. Now, there were some notable toxicities. There's GI toxicities such as diarrhea and nausea, as well as some elevations in LFTs. We also heard recently at ESMO about CodeBreak 200, which was a randomized study of sotorasib compared to docetaxel in previously treated patients with KRAS-G12C non-small cell lung cancer. And that study did meet its primary endpoint of improvement in PFS for sotorasib-treated patients compared to docetaxel, and we are very much looking forward to seeing that final publication. For HER2 alteration-positive non-small cell lung cancer, we really focused our efforts on DESTINY-Lung01. Now, this was a multi-center, multinational, open-label, phase II study evaluating trastuzumab deruxtecan in patients with previously treated HER2-positive non-small cell lung cancer. In this study, 91 patients were evaluable for response, and 50, which was 55%, had a confirmed objective response, and the median survival was presented at 17.8 months. A pretty unique toxicity was observed here. So, drug-related interstitial lung disease or pneumonitis occurred in just over a quarter of patients, and there were two deaths related to this. So, this needs to certainly be monitored for. Also at ESMO, we heard results for DESTINY-Lung02, which was a multi-center, multi cohort, randomized blinded study, which was also a dose optimization study. And this study eventually led to the accelerated approval of the 5.4 milligrams per kilogram dose that seemed to be just as effective as other doses, but perhaps with less toxicity. Again, we're currently awaiting the final publication of DESTINY-Lung02. However, these results are particularly impressive and especially leading to the FDA accelerated approval for a new treatment option for our patients with HER2 alteration positive non-small cell lung cancer. Brittany Harvey: I appreciate you reviewing that data and the new updates for both of these drugs and targets in this population. So then, I'd like to review the recommendations that the panel updated for our listeners. First, what is the new recommendation for patients with advanced non-small cell lung cancer and in activating HER2 mutation? Dr. Dwight Owen: So currently, these patients should continue to receive standard first-line treatment as we do not have head-to-head trials for HER2-directed therapy in the first line. However, for patients who have previously received systemic therapy and have a HER2-activating mutation, trastuzumab deruxtecan certainly should be offered to these patients. Brittany Harvey: Understood. And then the second category of patients that you identified, what does the expert panel recommend for patients with advanced non-small cell lung cancer and a KRAS-G12C mutation? Dr. Dwight Owen: So, similarly, these patients should continue to receive standard first-line treatment, as we do not have head-to-head trials for KRAS-directed therapy in the first line. However, for patients who have previously received systemic therapy and have a KRAS-G12C mutation, sotorasib can be offered as a subsequent therapy. Keep in mind that this is only approved in patients with the KRAS-G12C mutation, and not other KRAS alterations. Brittany Harvey: Thank you for reviewing those two recommendations for second or later-line therapies. What should clinicians know as they implement these updated recommendations? Dr. Dwight Owen: So, I think what we're really excited about is that both of these agents offer new treatment options for patients who historically did not have a personalized targeted treatment option. We are awaiting publication of additional studies to help interpret these data, but for now, clinicians should discuss these treatment options with their patients, and also keep in mind the pattern of toxicities that seem to be unique to each treatment. Brittany Harvey: Great. And then, you've just addressed some of this in your last response, but what does this change mean for patients with stage IV non-small lung cancer with a HER2 or KRAS-G12C mutation? Dr. Dwight Owen: I think the bottom line is that our patients for whom their cancer does not respond, or where it progresses after first-line treatment, will now have additional effective and approved treatment options that are really tailored to the unique characteristics of their tumor and cancer cells. Brittany Harvey: Absolutely. It's great to have new options for patients in this field. So then finally, are there future research developments that the panel is considering for future living guideline updates? Dr. Dwight Owen: So, we're particularly looking forward to the final publication of the studies that were recently presented, including the CodeBreak 200, and DESTINY-Lung02 trials. There are multiple ongoing studies for additional targets, including in the targets that we talked about; so, KRAS-G12C as well as HER2, as well as a number of other targeted options that may benefit subsets of our patients with metastatic non-small cell lung cancer. Brittany Harvey: Great. Well, I appreciate you reviewing all this data and the updated recommendations, and thank you for your time today, Dr. Owen. Dr. Dwight Owen: Thanks for having me. Brittany Harvey: And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. To read the full guideline, go to: www.asco.org/thoracic-cancer-guidelines. There's a companion living guideline update on therapy for stage IV non-small-cell lung cancer without driver alterations, available there and in the JCO. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, available on iTunes, 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 pod

19/12/2022

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8 min
29/08/2018

ASCO Guideline: Palliative Care in the Global Setting

Shadia Jalal, MD, Assistant Professor of Clinical Medicine in the Department of Medicine, Division of Hematology/Oncology at Indiana University School of Medicine discusses updated guideline for palliative care in the global setting. TRANSCRIPT Welcome to the ASCO Guidelines episode of the ASCO University weekly podcast. My name is Alexander Drilon, and I am the clinical director of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and editorial board member for ASCO University. Today, we feature an ASCO Guideline published in the Journal of Clinical Oncology. The episode you are about to hear was originally aired on the ASCO Guidelines podcast series. The ASCO Guidelines podcast series features interviews with panelists of recently-published ASCO clinical practice guidelines products, highlighting recommendations and noteworthy qualifying statements made by the expert panel. [MUSIC PLAYING] Hello, and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernan, and today, I'm interviewing Dr. Nahla Gaffer, from the Radiation S Isotope Center in Sudan, an author on palliative care in the global setting, American Society of Clinical Oncology resource-stratified practice guideline. Thank you for being here today Dr. Gaffer. Good morning. Thank you, so much, Mrs. Shannon for this opportunity. First, can you give us a general overview of what this guideline covers, and what it means to be a resource-stratified practice guideline? Yes. These guidelines outline and they cover the recommended set of palliative care integration concerning personnel needed, training needed for this staff, structure, and availability of medicines at different resource levels. And by a resource-stratified guideline, we mean that it's suitable for different levels of development. Yes. For example, if you are speaking about a community level, you are speaking of primary care centers, or if we are speaking about in a different setting, like a regional hospital and also, the highest level might be the oncology center. And at every level, there should be a better structure and better training and availability of palliative care. But at all of these levels, we should have palliative care. What are the key recommendations of this guideline? Yes. The key recommendations, as I mentioned, is that we should have a coordinated system, where the patient's palliative care needs are identified and met at every level and from the moment of diagnosis. So we are speaking about, at the basic level, we should have at least a volunteer or community worker or better even, a nurse trained in palliative care. And these people have got the job to facilitate identification of patients who need palliative care at the community level. Another level is the limited level, and here, we should have at least one doctor and a nurse trained in basic palliative care, and they work with the people working in the community. And they address minor issues, prescribing basic medicines, referring patients, and they also have the ability to support the patient and the family in [INAUDIBLE]. At another enhanced level, and we are speaking here about setting like a regional hospital, there should be a team, at least of three personnel-- doctor, nurse, pharmacist. Of course, if there is a psychologist or religious chaplain, it's OK, but at least these three personnel should be trained about palliative care, so a minimum of six weeks training. And they can provide palliative care, and they can offer as outpatient service in this regional hospital. The best setting or the maximum setting is when we are speaking about a bigger hospital or an oncology center. And we are speaking that no oncology center or any facility for palliative care patients, like hospices, should exist without a well-developed palliative care team. And having personnel and all personnel working in that center should receive basic training in palliative care. The main treating doctors, for example, the oncologists, should have secondary training in palliative care, so it's a higher level of training in palliative care. And we need for palliative care physicians to supervise and develop the service. At such a setting, we should have psychologists, we should have chaplains all integrated in the service. Another recommendation is that palliative care should be given and provided at all levels ideally, at the moment of diagnosis of the patient, but especially for patients who are coming with overwhelming symptoms, whether physical, psychological, or spiritual or patients who have metastasis or patients who cannot receive active treatment for curative intent, for example, for comorbidities or age or patients with a disease with a known short life expectancy. All these patients should receive palliative care from the moment of diagnosis. Why is this guideline so important, and how will it change practice? Yes, it is very important because palliative care is important to be given to all patients at every setting. It is not expensive. It doesn't require special equipment. It can be given. It not only should be given, but it can also be given. It's not difficult to change. And this guideline is very important, because sometimes people don't hear other colleagues or junior doctors. They hear high recommendations, like from the ASCO guidelines. And finally, how will these guideline recommendations affect patients? Yes. We hope the directors of hospitals, people or personnel at administerial levels, our fellow colleagues, they embrace these recommendations more and more. As I mentioned, sometimes it needs to come from higher up, and for that, we thank the American Society of Clinical Oncology for taking this task. Once we are caring for our patients holistically, which includes social, spiritual, psychological dimensions, in addition to physical, it leads to a better quality of life, affecting not only the patient and the family in all dimensions but even leading to a better survival, and here, I mean both in time and quality. Great. Thank you for your time today, Dr. Gaffer. Thanks. Thanks a lot. And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. If you've enjoyed what you've heard today, please rate and review the podcast and refer this show to a colleague. [MUSIC PLAYING] 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.

29/08/2018

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8 min

ASCO Podcasts by the American Society of Clinical Oncology, cover a range of educational and scientific content, offering enriching insight into the world of cancer care. Hear innovative interviews with the authors, researchers, and clinicians who are defining today’s standard of care and tomorrow’s breakthroughs. You can find all ASCO podcasts and limited series at ascopubs.org/podcasts