Podcasts about iraes

BUFFALO, NY - May 23, 2025 – A new #research paper was #published in Volume 16 of Oncotarget on May 19, 2025, titled “Immune-mediated adverse events following atezolizumab and bevacizumab in a multinational Latin American cohort of unresectable hepatocellular carcinoma." The study, led by first authors Leonardo Gomes da Fonseca from Hospital das Clínicas, Universidade de São Paulo, Brazil, and Federico Piñero from Hospital Universitario Austral, Argentina, investigated how patients with advanced liver cancer in Latin America respond to a widely used immunotherapy combination. The researchers found that although a minority of patients developed immune-related side effects, these events did not significantly impact overall survival. Their findings highlight the importance of early recognition and careful management of such side effects in real-world clinical settings. Liver cancer is a leading cause of cancer deaths worldwide, with limited treatment options for patients diagnosed at an advanced stage. Immunotherapy, particularly the combination of atezolizumab and bevacizumab, has become a standard approach. However, these treatments can sometimes trigger the body's immune system to attack healthy organs, leading to what are called immune-related adverse events, or irAEs. Until now, little data existed on how frequently these events occur in Latin American patients and whether they impact treatment outcomes. The researchers followed 99 patients from Argentina, Brazil, Chile, and Colombia, most of whom had cirrhosis or underlying liver disease. They received atezolizumab and bevacizumab for a median duration of six months. The researchers reported that only 18% of the patients experienced immune-related side effects, most commonly affecting the liver (hepatitis) and thyroid (thyroiditis). Most of these cases were mild or moderate, and half of them resolved completely within a month. Only eight patients needed treatment with steroids to control the immune response. Importantly, the occurrence of immune-related side effects did not affect how long patients survived after starting treatment. The median survival was the same—18.5 months—for both those who experienced irAEs and those who did not. This result suggests that while irAEs require careful management, they may not reduce the overall benefits of immunotherapy. Another significant finding was that patients with higher levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, were more likely to experience these side effects. This information could help clinicians identify patients who need closer control during treatment. “Notably, baseline alpha-fetoprotein (AFP) values ≥400 ng/ml were significantly associated with the development of irAEs.” The study also points to key differences between clinical trial results and real-world experiences. While clinical trials report higher rates of side effects, this real-world data showed a lower incidence, possibly due to less intensive monitoring or differences in how side effects are documented in everyday practice. In summary, this study highlights that patients require ongoing vigilance and individualized care when treating liver cancer with immunotherapy. It provides valuable information to healthcare providers in Latin America and other regions with similar patient populations, aiming to improve outcomes while minimizing risks. DOI - https://doi.org/10.18632/oncotarget.28721 Correspondence to - Federico Piñero - fpinerof@cas.austral.edu.ar To learn more about Oncotarget, please visit https://www.oncotarget.com. MEDIA@IMPACTJOURNALS.COM

Guest: Laura Cappelli, MD, MHS,MS Patients who are receiving immunotherapy for cancer sometimes develop significant autoimmune complications, which can be fatal. Join Dr. Laura Cappelli, Associate Professor of Medicine and Oncology at the Johns Hopkins University School of Medicine, as she explains how multidisciplinary collaboration can help manage these rheumatic immune-related adverse events (irAEs). Dr. Cappelli also spoke about this topic at the 2025 Congress of Clinical Rheumatology East conference.

Visit https://oncoassist.com/ to streamline patient care with cutting-edge tools, guidelines, and calculators! In this episode of Oncology Spotlight, we sit down with Aileen O'Meara, an Advanced Nurse Practitioner in Medical Oncology at St. Vincent's Hospital, Dublin, with over 30 years of experience in oncology nursing. Aileen shares invaluable insights into the changing landscape of cancer treatment, the role of advanced nurse practitioners, and the impact of immunotherapy on patient care.From discussing common immunotherapy side effects (irAEs) to new innovations in oncology nursing, this episode is packed with expert insights that every oncologist, nurse, and healthcare professional should hear.Listen now to learn:✅ How oncology nursing has evolved over the years✅ The role of Advanced Nurse Practitioners in cancer treatment✅ Managing immune-related adverse events (irAEs) in patients✅ How nurses differentiate side effects of immunotherapy vs. chemotherapy✅ The latest oncology innovations & future treatment trends✅ The role of AI & technology in supporting oncology nurses

CME credits: 0.25 Valid until: 05-02-2026 Claim your CME credit at https://reachmd.com/programs/cme/virtual-tumor-board-maximizing-the-potential-of-immuno-oncology-in-early-tnbc-through-personalized-care/29461/ Tune in for a deep dive into the evolving landscape of immuno-oncology (IO) in early-stage triple-negative breast cancer (TNBC). Our experts focus on identifying eligible patients for neoadjuvant and adjuvant IO regimens, understanding current and emerging treatment options, and effectively utilizing shared decision-making (SDM) techniques to tailor treatment plans. The activity also covers the importance of recognizing and managing immune-related adverse events (irAEs) in the perioperative setting. Learn to optimize the use of IO in early-stage TNBC and improve your patients' outcomes and quality of life. =

Happy New Year! This week's episode will go over important details related to immune checkpoint inhibitors (ICIs) and immune-related adverse events (irAEs), with general management strategies for each of the most common iRAEs.

Click here to view the full activity and claim free NCPD credit! https://i3health.com/course-information/managing-immune-related-adverse-events-to-ensure-optimal-cancer-immunotherapy-outcomes-the-nurses-view At last year's Greater Los Angeles Oncology Nursing Society (GLAONS) Oncology Care Summit, i3 Health hosted a nursing continuing professional development (NCPD) symposium entitled Managing Immune-Related Adverse Events to Ensure Optimal Cancer Immunotherapy Outcomes (IRAEs): The Nurse's View, chaired by Blanca Ledezma, MSN, NP, AOCNP®, Hematology/Oncology Nurse Practitioner at UCLA Health. With numerous advances in the immunotherapy space occurring since the symposium was held, Oncology Data Advisor Editorial Board member Beth Sandy, MSN, CRNP, Outpatient Thoracic Oncology Nurse Practitioner at the University of Pennsylvania Abramson Cancer Center, sat down to discuss some of these updates in lung cancer and her own insights on optimal management of IRAEs from the nursing perspective.

Immunotherapy is a type of novel cancer therapy that leverages the body's own immune system to target cancer cells. In this episode, we focused on the most common type of immunotherapy: immune checkpoint inhibitors or ICIs. ICIs are monoclonal antibodies targeting immune “checkpoints” or brakes to enhance T-cell recognition against tumors. ICI has become a pillar in cancer care, with over 100 approvals and 5,000 ongoing trials. ICIs can lead to non-specific activation of the immune system, causing off-target adverse events such as cardiotoxicities. ICI-related myocarditis, though less common, can be fatal in 30% of cases. Clinical manifestations vary but can include chest pain, dyspnea, palpitations, heart failure symptoms, and arrhythmias. Diagnosis involves echocardiography, cardiac MRI, and endomyocardial biopsy. Treatment includes high-dose corticosteroids with potential additional immunosuppressants. Baseline EKG and troponin are recommended before ICI initiation, but routine surveillance is not advised. Subclinical myocarditis is a challenge, with unclear management implications. So let's dive in and learn about cardiotoxicity of novel immunotherapies with Drs. Giselle Suero (series co-chair), Evelyn Song (episode FIT lead), Daniel Ambinder (CardioNerds co-founder), and Tomas Neilan (faculty expert). Audio editing by CardioNerds Academy Intern, Dr. Maryam Barkhordarian. This episode is supported by a grant from Pfizer Inc. This CardioNerds Cardio-Oncology series is a multi-institutional collaboration made possible by contributions of stellar fellow leads and expert faculty from several programs, led by series co-chairs, Dr. Giselle Suero Abreu, Dr. Dinu Balanescu, and Dr. Teodora Donisan.  CardioNerds Cardio-Oncology PageCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor Roll CardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron! Pearls and Quotes - Cardiotoxicity of Novel Immunotherapies Immune checkpoint inhibitors (ICI) play a crucial role in current oncology treatment by enhancing T-cell recognition against tumors. ICI-related cardiac immune-related adverse events (iRAEs) include myocarditis, heart failure, stress-cardiomyopathy, conduction abnormalities, venous thrombosis, pericardial disease, vasculitis, and atherosclerotic-related events. ICI myocarditis can be fatal; thus, prompt recognition and treatment is crucial. Management includes cessation of the ICI and treatment with corticosteroids and potentially other immunosuppressants. Close monitoring and collaboration with cardiology and oncology are crucial. Rechallenging patients with immunotherapies after developing an iRAE is controversial and requires careful consideration of risks and benefits, typically with the involvement of a multidisciplinary team. Show notes - Cardiotoxicity of Novel Immunotherapies What are immune checkpoint inhibitors (ICIs)? ICIs are monoclonal antibodies used to enhance the body's immune response against cancer cells. Currently, there are four main classes of FDA-approved ICIs: monoclonal antibodies blocking cytotoxic T lymphocyte antigen-4 (CTLA-4), programed cell death protein-1 (PD-1), lymphocyte-activation gene 3 (LAG3), and programmed cell death ligand-1 (PD-L1). ICIs can lead to non-specific activation of the immune system, potentially causing off-target adverse events in various organs, including the heart, leading to myocarditis.    The mechanisms of cardiac iRAEs are not fully understood, but they are believed to involve T-cell activation against cardiac antigens, which leads to inflammation and tissue damage.  What are the cardiotoxicities related to ICI therapies? ICI-related cardiac immune-related adverse events (iRAEs) include myocarditis, heart failure, stress-cardiomyopathy, conduction abnormalities, venous thrombosis, pericardial disease, vasculitis,

When a patient is diagnosed with cancer, treatments that force the immune system into overdrive are given in hopes that it will recognize the cancer and destroy it. Unfortunately, this can mean that various Immune Related Adverse Events (IRAEs) can occur. In rheumatology, our treatments are meant to tame an overactive immune system, creating a unique dilemma. Joining us today is Dr. Laura Cappelli, MD, MHS. Dr. Cappelli explains what these IRAEs really are, how they commonly occur, what risk factors exist in their development, the importance of a multidisciplinary approach to treatment and much, much more. 

Drs. Diwakar Davar and Ben Boursi discuss the role of the gut microbiome in the outcome of cancer immunotherapy and the prevention of immunotherapy-related adverse events, as well as compelling research on nutritional interventions to improve response to immune checkpoint inhibitors. TRANSCRIPT   Dr. Diwakar Davar: Hello, and welcome to the ASCO Daily News Podcast. I'm your guest host, Dr. Diwakar Davar. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center.   Researchers have shown that microorganisms in the gut can impact the effectiveness of immunogenic chemotherapy for patients with cancer. Although microbial therapies for cancer are still at a very early stage of clinical development, compelling research in recent years has shown that changing the gut microbiome can help improve outcomes in patients receiving treatments for cancer enduring immune checkpoint inhibition.  My guest today is Dr. Ben Boursi, a GI medical oncologist at the Sheba Medical Center at Tel Aviv University in Israel. Dr. Boursi is also an adjunct professor at the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania. He joins me today to discuss his pivotal research on the role of the gut microbiome in mediating its effects on immunotherapy. And again, I want to highlight that we're recording this on October 9th, and as you may well know, many recent events over the last couple of days have happened in Israel, and so Dr. Boursi has joined us at a very difficult time. So, we're very grateful for him taking time out of his suddenly very busy schedule to join us at a time that is fraught for all. You'll find our disclosures in the transcript of this episode. You'll also find the disclosures of all guests on the podcast at asco.org/DNpod. Ben, it's great to have you on the podcast today. Thank you for being here at such a difficult time, sharing what will, I think, be a great episode.  Dr. Ben Boursi: Thanks for having me, Diwakar. Dr. Diwakar Davar: Ben, the gut microbiome and its role in terms of mediating effects and side effects of cancer immunotherapy has gotten a lot of interest recently. You've done some fundamental work in this space. Why don't you briefly summarize for the audience, firstly, what is the gut microbiome and what are the major themes in relation to cancer immunotherapy?  Dr. Ben Boursi: Well, the microbiome is the ecosystem of microorganisms, bacteria, phages, fungi, that are crucial for immunologic, metabolic and hormonal homeostasis of the host. In the last decade, we began to understand the central role of the gut and tumor microbiome in tumorigenesis, metastasis, treatment efficacy and toxicities, and in 2022, polymorphic microbiomes became one of the hallmarks of cancer, in addition to previous hallmarks that focused mainly at the cellular/genetic levels. The initial studies in mice models showed that therapeutic efficacy of immunotherapy depends on both the presence and composition of the microbiota (In germ-free or antibiotic treated mice, immunotherapy is ineffective), and following these studies, three observational studies in human patients showed that the gut microbiome can predict response to immunotherapy and that response to immunotherapy could be transferred to germ-free mice by fecal microbiota transplantation (FMT) from responding patients.  These studies helped us to define three main research questions regarding the possible role of microbial modulation in cancer treatment. First, can microbial modulation overcome resistance to immunotherapy, both primary and secondary resistance? And this question was the focus of the initial proof of concept studies. Second, can microbial modulation improve response to immunotherapy in treatment-naive patients? And third, can microbial modulation prevent or treat immune related adverse events? The initial positive results of clinical trials also led to additional questions. For example, can microbial modulation induce anti-tumor immune response even in non-immunogenic tumors? And it is important to note that there are many ways to modulate the microbiota, but so far, the only reliable way that showed positive results is fecal microbiota transplantation that allows the transfer of the entire microbiota both in terms of composition and relative abundance. Dr. Diwakar Davar: That's great. Essentially with the trials that I think the data sets that you're referencing of course, are papers by Jennifer Wargo, Thomas Gajewski, and Lawrence Zitvogel, looking at the role of gut microbiota in several different cancers, primarily immune checkpoint sensitive tumors such as melanoma, non-small cell lung cancer and kidney cancer. And then the work from several different groups showing that essentially proof of concept experiments can be done to try to change this, certainly preclinically, and now we know that that can be done clinically.   So, I guess the failure rates of immunotherapy in some patients are quite high. And we know that the microbial composition can change the likelihood to respond to immunotherapy based on all these trials. And actually, even going back to 2015, we had two seminal papers that looked at the role of CTLA-4 blockade as well. But subsequently, many years after that, 7 years after 2015, and certainly 3 years after 2018, when the three observational PD-1 papers were published, there were 2 pivotal trials in PD-1 advanced or refractory melanoma. They demonstrated that changing the gut microbiome can reprogram the immune system to attack tumors. So, there were 2 separate trials, both published the same issue of Science. One trial was led by your group at Sheba, and another one's led by us, the University of Pittsburgh. Why don't you summarize both studies for our audience. Dr. Ben Boursi: So, both studies were Phase I clinical trials of FMT in metastatic melanoma patients who failed immunotherapy. Recipients were metastatic melanoma patients that progressed on at least one line of anti PD-1 and in BRAF mutated patients, BRAF inhibitors as well. Donors in the Sheba study were metastatic melanoma patients with durable complete responses to immunotherapy for at least one year, and in the Pittsburgh study, you also included patients with durable partial responses of more than two years as donors. It is important to note that each fecal transplant in both studies was composed of a single donor. Prior to transplantation, we performed a microbiome depletion phase using a combination of two antibiotics, vancomycin and neomycin. The goal of this phase was to assist in engraftment (by avoiding colonization-resistance by recipient bacteria) and to “reset” the immune system, which may remind some people of the logic behind bone marrow transplantation. In the Pittsburgh study, there was no bacterial eradication with antibiotics, mainly because of studies showing that response to immunotherapy is lower following antibiotic treatment.  Both studies performed FMT through colonoscopy. At Sheba, we also performed maintenance FMT using capsules in order to keep the donor's microbial composition. After the initial FMT, both studies reintroduced the same immunotherapy in which the patient progressed in the past. Clinically, we have seen a 30% response rate with durable, complete and partial responses, and in the Pittsburgh study, there was a 20% response rate and 40% disease control rate. Both studies showed following FMT, immune response in the gut and in the tumor, and tumors that were immune deserts prior to FMT became infiltrated with lymphocytes. Interestingly, in our study, there were no moderate to severe immune related adverse events following FMT and reintroduction of immunotherapy. And this is despite the fact that five of the patients had significant side effects during previous rounds of the same immunotherapy.  Dr. Diwakar Davar: So essentially, in these very early proof of concept studies, what I think is pretty remarkable is that obviously the sample sizes were very small, but remarkably, patients that appeared to respond, responded in a setting in which they were not expected to respond. So, the probability of a patient responding to attempt at giving PD-1 in patients who were PD-1 relapse refractory is on the order of about 7%, based on an FDA analysis by Viva et al. And here, two separate studies, two independent studies, investigators had not known that each paper was being published, remarkably similar results clearly demonstrating that this is perhaps one of the best pieces of evidence to suggest that microbiome modulation may actually truly be effective in reversing PD-1 refractoriness.  More recently, our colleague Dr. Bertrand Routy at University of Montreal has done a proof of concept trial in evaluating the use of healthy donor fecal microbiota transplant in addition to anti PD-1 monotherapy in PD-1 naive metastatic melanoma. In this study, published in Nature Medicine a few weeks ago, his group reported an objective response rate of 65%. What are your thoughts about this study? And specifically, what are your thoughts about some of the pharmacodynamic and translational results that were demonstrated?  Dr. Ben Boursi: This is a very interesting question, because in both the Sheba and the University of Pittsburgh studies we chose responding patients as donors. We thought that by using these patients, we provide beneficial bacteria that enhance responses to immunotherapy through several mechanisms (molecular mimicry, immunomodulatory bacterial metabolites, modulation of immune checkpoint expression, and much more), and here in the Routy paper, the researchers used FMT from healthy donors without any selection for specific beneficial bacteria, and they demonstrated a similar effect on overall response rate. So maybe FMT works actually through reducing colonization by deleterious bacteria? Another question that we should ask is whether we need to choose donors differently when we use microbial modulation in treatment resistant patients compared to treatment-naive patients? Moreover, a previous meta-analysis of FMT studies across indications that was conducted by the group of Dr. Nicola Segata, demonstrated that recipients with better engraftment were more likely to experience clinical benefit, and that increased engraftment was mainly observed in individuals receiving FMTs through multiple routes, colonoscopy and capsules, as well as recipients that received antibiotics prior to FMT. But in Routy's trial, they not only used healthy donors, they performed bacterial cleansing only prior to FMT instead of bacterial eradication with antibiotics, and used FMTs through colonoscopy only, and they didn't give maintenance FMT. Of course, such an approach is much more feasible in the clinical setting and is relevant for designing future clinical trials.  Dr. Diwakar Davar: So, many differences, relatively few similarities, but I guess one interesting point is that of engraftment, which is that in your paper, our paper, and certainly in Bertrand's paper, it is very interesting that engraftment appears to be a key pharmacodynamic biomarker of microbiome modulation. And certainly, the analogy that you used earlier, which is that it's very similar to what happens in a stem cell transplant, which is that if there's no take, there's probably not going to be any effect. So that's very interesting that engraftment is emerging as a key PD biomarker of essentially the success of any kind of microbiome modulation across multiple different settings.  Now, we've heard of certainly defined microbial consortia, of cultivated species, as an alternative gut microbiome modulation strategy that balances the benefits of the ecological complexity of FMT with the scalability and practicality of probiotics. Do you think we are ready to design consortia?  Dr. Ben Boursi: So to date there are several probiotics that use a single bacteria and several microbial consortia that were evaluated in clinical trials, and as you mentioned, they may offer more tractable solutions for widespread clinical use. If we begin with the single bacteria probiotics, two phase 2 clinical trials found that administration of the butyrate producing probiotic clostridium butyricum 588 (CBM588) to immunotherapy naive patients with metastatic renal cell carcinoma led to markedly better immunotherapy responses, although the probiotic had a minimal effect on the composition of the microbiota, and the control arm of the trial responded worse than expected. In addition, in preclinical studies, probiotic strains of lactobacillus and bifidobacterium have been shown to enhance immune control of transplanted tumors and to augment anti PD-1 activity. However, a clinical trial in patients with metastatic melanoma found that the use of lactobacillus or bifidobacterium probiotics was associated with reduced microbiota diversity and worse responses to anti PD-1.  So here the conclusion is that when we try to design probiotics, we should not focus only on the composition since other factors, such as the relative abundance also matter. Too much of a beneficial bacterial species may potentially be worse than having a balanced and diverse microbiota. For example, a recent study of patients with non-small cell lung cancer receiving immunotherapy found that patients with a detectable Akkermansia muciniphila in their gut microbiota (this is a beneficial bacteria) responded well to treatment, but those with relative abundance of Akkermansia muciniphila greater than 5% responded worse than patients lacking Akkermansia, and this is due to the mucolytic effect of the bacteria. So, the use of rationally designed consortia may be better than a single probiotic strain.  And there are currently 3 main microbial consortia that are being evaluated: the SER-401, a bacterial consortium enriched with clostridium, led in a randomized controlled trial to reduced response to immunotherapy compared to placebo control in first line metastatic melanoma patients, potentially due to a confounding effect of a vancomycin pretreatment; MET4 is a 30 bacteria consortium that was shown to be safe and to alter the gut microbiota and serum metabolome of immunotherapy naive patients. Here, the initial study was underpowered to determine the effect on treatment efficacy; And finally, VE800 is an immunotherapy enhancing 11-bacterial consortium that is currently being evaluated in phase 1 and 2 clinical trials, and we are looking forward to see the results with this agent. Dr. Diwakar Davar: So I guess where we are right now is that social design is clearly difficult because of all the reasons you've mentioned. The SER-401 data and the MET4-IO trials certainly give us pause for thought. Certainly, no pharmacodynamic changes that were seen with SER-401, MET4-IO did result in pharmacodynamic shifts metagenomically, but neither trial was positive. And certainly, the VE800 trial, which has been ongoing now for several years, and the lack of publicly reported data certainly doesn't suggest that there's a huge efficacy signal. So consortias, at least at this point, certainly do not appear to be having a significant effect, though we don't know what might happen in the future. Data from multiple groups has shown that gut microbial composition influences the development of immune related adverse events (irAEs) in both PD-1 and combination PD-1 and CTLA-4 treated patients. Unsurprisingly, as a result, there have been attempts made at evaluating the role of fecal microbiota transplants to treat refractory immune related adverse events and very specifically immune checkpoint associated colitis or IMC. So, Dr. Yinghong Wang, who is the chair of the Immunotherapy Toxicity Working Group at the University of Texas MD Anderson Cancer Center has been very prominent in this space, and in a recent paper published in Science Translational Medicine, which is a follow up paper to her early work in Nature Medicine, she reported that HDFMT, healthy donor fecal transplantation, was very efficacious in feeding early refractory immune checkpoint colitis. So, what are your thoughts on this approach and how important is this space and where else might it be efficacious?  Dr. Ben Boursi: When I talked about the Sheba clinical study, I mentioned the possible role for microbiota modulation in the prevention of immunotherapy related adverse events in general, not only colitis. But the study by Dr. Yinghong showed that FMT can actually treat immune-related colitis refractory to steroids and anti-TNF. Now, this approach is probably relevant not only for immune related colitis, but also to other immune related adverse events. We can define certain bacterial species that may be associated with different immune related events. For example, streptococci can be associated with immune related arthritis. And maybe in the future we won't need to use FMT, but we will rather be able to target these specific immunogenic strains by narrow spectrum antibiotics or phages. The main challenge would be to develop microbiotic targeting interventions that reduce immune related adverse events without compromising therapeutic efficacy.   Now, is microbial modulation relevant only for toxicity from immune checkpoint inhibitors? So, the answer is ‘no'. We know mainly from animal models of hematopoietic cell transplantation, CAR T, and immune agonist antibodies that antibiotic-treated or germ-free mice have markedly reduced immunotoxicity, such as graft versus host disease, cytokine release syndromes, and more. It is also worth mentioning that microbial modulation is relevant not only for reducing toxicity from immunotherapy, but also from chemotherapy and other anticancer modalities. And the best example is the gastrointestinal toxicity of irinotecan that is mediated by the bacterial beta-glucuronidase. And here the targeting may even be a bit less complex. Dr. Diwakar Davar: So, what we take away from that is that starting with actually your paper originally, and papers to be produced, immune-related adverse events can be prevented using microbiome modulation with FMT, and Dr. Wang's data suggesting that eventually FMT can be used to eradicate highly refractive colitis, again, this is important to keep in mind that this approach is not yet FDA-approved. It's being done under IND. It's not currently something that is a certain standard of care. One interesting area of drug development is that there's a French microbiome company named MaaT Pharma where they have an agent that is a very interestingly a pooled microbiome product from multiple different donors. Again, the trials in both Israel and Pittsburgh used individual donors. This is a pooled donor construct. The lead candidate is actually graft versus host disease. The trial is the ARES trial, A-R-E-S, as in the Roman god of war. This trial is actually ongoing in Europe, and I believe there's some effort to try to see whether or not it's going to be a trial that can be done in the United States as well. So, at this point in time, again, we don't know whether or not there are any developmental approaches from a pharmaceutical company in the United States, but certainly this is definitely an area of interest.  So microbial therapies are still relatively early. It's going to be interesting to see how the advanced field of nutritional interventions provide an appealing method for modulating the gut microbiome due to the excellent safety profile, cost effectiveness and noninvasiveness. And certainly, if you are what you eat and your bacteria are what they eat, which goes down to our diet, there's enough rationale to believe that certain nutritional interventions can have an effect via the intermedial gut microbiota modulation. Holistic dietary changes and or supplementation specific nutrients such as prebiotics could therefore be utilized to specifically shape the population of beneficial microbes and shift the immune microbiota landscape. Now, we have seen in data published by several of our colleagues that in patients with cancer, high fiber intake is associated with greater microbial diversity, greater abundance in fiber fermenting microbes such as members of the Ruminococcaceae family, and these are all associated with the response to checkpoint inhibitor therapy. So, what do you think about nutritional interventions? Do you want us to briefly summarize data regarding nutritional data and where it stands in cancer at his time? And can you speculate as to how effective this might be in the context of patients with cancer? Dr. Ben Boursi: So, let's begin with diet. A growing number of clinical and preclinical studies suggest that specific dietary interventions such as a high fiber diet can not only improve response to immune checkpoint blockers, but also reduce immunotoxicity such as graft versus host disease. And there are many other diets that are being tested such as ketogenic diets and intermittent fasting. And the effects of diet may be mediated by both microbiota-dependent and microbiota-independent mechanisms. The limitation of this approach is that changes to the microbiota induced by diet are generally quite variable between patients and can depend on an individual's microbiota prior to intervention. And patient compliance is also a concern, particularly in the very strict diets.  Now, regarding high fiber diets, several large cohorts of melanoma patients from the US, Australia, and the Netherlands demonstrated how a high fiber diet modulates the microbiome and results in a better response to immunotherapy, better progression-free survival. Additional studies that were presented at AACR in 2023 showed that high fiber dietary interventions, in which patients received a fiber-enriched diet for six weeks, was feasible and that the high fiber diet resulted in a rapid shift in the gut microbiota toward fiber-responsive short chain fatty acid-producing taxa and a shift of the metabolome, with increase in the short chain fatty acid acetate, Omega-3, Omega-6, polyunsaturated fatty acid, and tryptophan metabolites. Prebiotics can also promote the growth of beneficial microbial species in the gut by providing targeted nutrition. And one example of a prebiotic that was shown to enhance immunotherapy efficacy in mouse models is castalagin, which is isolated from the camu-camu berry. Castalagin directly binds the outer membrane of ruminococci and promotes their growth, which has been shown to increase the CD8-positive T-cell activity and anti-PD-1 efficacy. Now, since prebiotics rely on the presence of beneficial taxa already in the host microbiota, symbiotics, which refers to the administration of the appropriate prebiotic and probiotic together, may prove in the future to be more effective than using either separately. Dr. Diwakar Davar: Certainly, these dietary interventions can be very exciting and certainly we do know of several colleagues who are doing these diet interventions, though compliance with any kind of dietary intervention may be a challenge that decides how effective such an approach is going to be. So microbial therapies in general are still at a relatively early stage of development. And it'll be exciting to see how they advance. What approaches are you excited about? What is on your radar?  Dr. Ben Boursi: There are many exciting works that are currently ongoing, and to emphasize just a few: there are many clinical trials in immunogenic tumors, in addition to melanoma, for example, renal cell carcinoma, and non-small cell lung cancer, that also evaluate different modulation protocols. We should remember that one size does not fit all, and different tumors have different microbiomes. We have a project in collaboration with MD Anderson in MSI-high patients with exciting initial results. Another study that was initiated at Sheba is using microbial modulation in order to improve TIL therapy (to overcome resistance to TIL and T-cell exhaustion). There are also studies that try to change the pharmaco-microbiome, for example, to eradicate bacteria that inactivates the chemotherapy agent, gemcitabine, in pancreatic cancer patients. And there are groups that try to identify recipients that will respond to microbial modulation and to generate better donor-recipient matching algorithms. There are already signatures like TOPOSCORE that was presented at ASCO 2023 that try to predict response to immunotherapies through the ratio between harmful and beneficial bacteria. Now, there's also more basic science work, for example, bacterial engineering. There was a wonderful study from the Fischbach group in Stanford that demonstrated how Staphylococcus epidermidis engineered to express melanoma tumor antigens was able to generate a systemic tumor-specific response in mice models when applied topically; functional imaging of the microbiome, for example, FDG uptake in the colon can reflect microbial diversity and response to immunotherapy; works that characterizes other microbiomes such as the urinary and skin microbiomes, and their interaction with the gut microbiome; and studies of the nonbacterial component of the microbiome, mainly phages and fungi. But for me, the most important word should probably be collaboration, because without joining forces internationally, we won't be able to understand the human metaorganism, the variations according to geography, ethnicity, lifestyle, diets, and much more in the microbiome. And this is crucial in order to really understand the complex tumor ecological niche within the human host. Dr. Diwakar Davar: I think one of the key points that you just mentioned is collaboration. That's going to be very, very critical as we move this forward for many reasons, including the unexpected impact of geography upon the composition of the gut microbiome in work that has been published by many groups, but also including ours in a paper that we published about a year ago now.  So, Dr. Boursi, thank you for your great work in this area. Thank you for sharing your insights with us today on the ASCO Daily News Podcast. This is a very difficult time for all of you and your colleagues in Israel, and we thank you so much for taking such a great deal of time out of your busy workday to spend some time with us.  Dr. Ben Boursi: Thank you very much. Dr. Diwakar Davar: Thank you to all our listeners today. This is a very exciting area. This is an area where we are discovering more every day than we knew just up until the day prior. You will find the links to the studies that were discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take the time to rate, review, and subscribe wherever you get your podcast.  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. Guests' 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.   Follow today's speakers:   Dr. Diwakar Davar  Dr. Ben Boursi   Follow ASCO on social media:   @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn      Disclosures:   Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy       Dr. Ben Boursi: No relationships to disclose.        

Kerry Reynolds, MD, and Han Zhu, MD, discuss the role of biomarkers in surveillance and management of cardiovascular IRAEs and review future directions in the field of IRAEs. Moderated by Sarah Waliany, MD, MS.

Between 4% to 15% of patients with cancer who are treated with a class of medications called immune checkpoint inhibitors experience immune-related adverse events (irAEs), including hypothyroidism, hyperthyroidism, and insulin-deficient diabetes. Delayed access, diagnosis, and management of irAEs are often causes of preventable hospital admissions in cancer patients. At Duke Cancer Institute, the implementation of electronic-consults for patients experiencing endocrine irAEs improved patient access and reduced healthcare utilization. Time to appointment and hospitalizations were reduced from 61 days to 39 days and from 11% to 2%, respectively. To propel integration and scalability, the next step is to ensure adequate reimbursement from payers for these types of e-consults. Guest: Afreen Shariff, MD, MBBS Director, Duke Endo Oncology Program Associate Director, Cancer Therapy Toxicity Program, Center for Cancer Immunotherapy Duke Cancer Institute Durham, North Carolina  “I've been a strong advocate to fix the effort and reimbursement mismatch because these are very different from traditional e-consultative services…the acuity of patients is different. The level of expertise that is needed to triage and give recommendations to patients is different…the reimbursement we get through third party-payers is what I call the ‘coffee and bagel' consult because it really doesn't do justice to the kind of service we provide.” This podcast is part of a special series with the 2023 ACCC Innovator Award winners. For a deeper dive into this and other content that will help your team reimagine how care is delivered at your cancer program or practice, register today for the ACCC 40th National Oncology Conference, Oct. 4-6, in Austin Texas.   Resources: Managing irAEs into Post-Treatment Survivorship Working with Rheumatologists to Manage irAEs Adverse Event Management in the Community-Based Immuno-Oncology Clinic Virtual Toxicity Team Cleveland Clinic Perspective on Managing Immune-related Adverse Events Working with Rheumatologists to Manage irAEs

CME credits: 1.00 Valid until: 17-07-2024 Claim your CME credit at https://reachmd.com/programs/cme/how-can-we-best-manage-iraes-during-adjuvant-icis-for-melanoma-a-case-based-approach/15782/ This program is designed to improve clinicians' knowledge of the latest clinical trial data surrounding the use of immunotherapy for the adjuvant treatment of patients with melanoma. The program addresses clinical challenges faced by oncologists/surgeons, including selecting appropriate patients, determining optimal treatment schedules and dosing, and managing toxicity.

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

Go online to PeerView.com/CFM860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity based on a live MasterClass and Nursing Practice Forum, leading experts present concise learning modules combined with workshop-style demonstrations and case-based discussions to provide a practical framework for oncology nurses to facilitate optimal clinical integration of immunotherapies in advanced/metastatic and early-stage NSCLC, offering strategies to educate patients about this therapeutic class, mitigate acute and chronic immune-related adverse events (irAEs), and support patients through treatment and survivorship to help them achieve the best possible quality of life and outcomes. Upon completion of this activity, participants should be better able to: Describe the mechanisms of action, safety and efficacy, and current and emerging roles of immune checkpoint inhibitors (ICIs) and combinations in advanced- and early-stage NSCLC; Collaborate with the interprofessional team to safely and effectively integrate ICI-based regimens into individualized treatment plans for eligible patients with advanced- and early-stage NSCLC; Implement best practices for diagnosing and managing irAEs in patients with NSCLC receiving treatment with ICIs and combinations; and Provide education, guidance, and support to patients with NSCLC and their caregivers about ICI-based treatment options, importance of being vigilant about irAEs, and how to overcome challenges and optimize outcomes during treatment and survivorship

“Just like with anything we do in oncology, a lot of education is required. Nurses and coordinators are critical to start the education and provide effective resources that are reinforced throughout the treatment,” ONS member Beth Faiman, PhD, MSN, APN-BC, AOCN®, BMTCN®, FAAN, FAPO, advanced practice provider at Cleveland Clinic in Ohio, told Lenise Taylor, MN, RN, AOCNS®, BMTCN®, oncology clinical specialist at ONS, during a conversation about how to address knowledge gaps and barriers to practice regarding patients who are preparing for or who have received CAR T-cell therapy for hematologic malignancies. Faiman was one of the content experts for two ONS focus groups on the topic in March 2023. This podcast episode is produced by ONS and supported by funding from Janssen Oncology and Legend Biotech. ONS is solely responsible for the criteria, objectives, content, quality, and scientific integrity of its programs and publications. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Episode Notes NCPD contact hours are not available for this episode. Oncology Nursing Podcast episodes: Episode 1: Experiences With CAR T-Cell Therapy Episode 139: How CAR and Other T Cells Are Revolutionizing Cancer Treatment Episode 176: Oncologic Emergencies 101: Cytokine Release Syndrome ONS Voice articles: Studies Show Best Practices to Manage CAR T-Cell Therapies' irAEs and Improve Outcomes CAR T-Cell Therapy Programs: Essential Elements to Establish a Successful System A Body of Evidence Helps Nurses Manage CAR T-Cell Therapy Toxicities Clinical Journal of Oncology Nursing articles: CAR T-Cell Therapy: Updates in Nursing Management Building a Program: Implications for Infrastructure, Nursing Education, and Training for CAR T-Cell Therapy Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-Cell Therapy in Multiple Care Settings ONS clinical practice resources: Chimeric Antigen Receptor T-Cell Therapy: A Timeline of Events and Adverse Events Cytokine Release Syndrome ONS course: Nursing Considerations for CAR T-Cell Therapy for Patients With Hematologic Malignancies: Patient Education and Symptom Management ONS videos: CAR T-Cell Therapy Cytokine Release Syndrome American Society for Transplantation and Cellular Therapy Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated With Immune Effector Cells International Myeloma Foundation Leukemia and Lymphoma Society Multiple Myeloma Research Foundation New England Journal of Medicine article: Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma Transplantation and Cellular Therapy article: Overcoming Barriers to Referral for Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma Learn more about CAR T-cell therapy and risk evaluation and mitigation strategies (REMS). To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “Just like with anything we do in oncology, there is a lot of education that is required. The same navigators that take care of our patients through the transplant and cellular therapy process, we have similar cellular coordinators that were part of the focus group. These navigators were critical to start the education and provide effective resources that were reinforced throughout the treatment.” Timestamp (TS) 09:00 “The nurses and coordinators play a huge role during the transition of care. Not only do they help with coordinating appointments, but also the scheduling of tests and coordinating with the referring team. I heard a lot in the focus groups about the nurses communicating from inpatient to outpatient, and also coordinating from center to center.” TS 10:22 “Patients can get really nervous when they're feeling sick. I explain it to them like, “You know how you get a flu shot, and you might get a little reaction as we're training your immune system to provide immunity? Well, it's like that, but way worse.' So, you can get really sick feeling and achy from this, and so that psychosocial support is super important.” TS 18:16 “It takes a lot of burden on the patient, caregiver, and the nurse to really be astute to those symptoms and intervene. We do provide wallet cards to patients. We educate the emergency department staff. We also heard about the infection monitoring and caregiver support is absolutely critical. Fortunately, the symptom management has become quite standardized, which really affords the nurses more autonomy to intervene more efficiently.” TS 20:46 “The nurses found for education a teach-back tool to be quite useful. One of the nurses mentioned asking the patient questions such as, ‘What will you do when you have a fever? Tell me what you do,' and “What do you understand from what the doctor just told you?' And so that was just kind of a way that they could go back and forth with the educational process and really understand what the patients understood.” TS 25:46

This episode of OncoSnacks kicks off Michael and Josh's sojourn into the wide world of immune-mediated adverse effects. Inevitably, as most blowhards do, they begin with the lungs. Immune-mediated pneumonitis is not as common as endocrine-axis abnormalities, dermatitis or colitis, but it can be insidious and devastating in equal measure. Such is the potential impact that must be considered in any patient who has received immunotherapy and presents with dyspnoea or a dry cough. Listen to learn more, and you will also know what irAEs and Senator Joseph McCarthy have in common.Guidelines for the management of Immune-Mediated Pneumonitis are available at:https://www.frontiersin.org/articles/10.3389/fonc.2020.01785/full#:~:text=will%20be%20discussed.-,Incidence%20and%20Risk%20Factors,due%20to%20pneumonitis%20(6)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161534/https://www.eviq.org.au/clinical-resources/side-effect-and-toxicity-management/immunological/1993-management-of-immune-related-adverse-eventsFor more episodes, resources and blog posts, visit www.inquisitiveonc.comFind us on Twitter @InquisitiveOnc!If you want us to look at a specific trial or subject, email us at inquisitiveonc@gmail.comArt courtesy of Taryn SilverMusic courtesy of:- Music Unlimited: https://pixabay.com/users/music_unlimited-27600023/- SoulProdMusic: https://pixabay.com/users/soulprodmusic-30064790/Note: This podcast is for educational purposes only. If you are unwell, seek medical advice Hosted on Acast. See acast.com/privacy for more information.

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/SFP860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Immune checkpoint inhibitors (ICIs) have had a strikingly positive impact on the treatment of a range of cancer types by blocking intrinsic downregulators of the immune response to increase antitumor immunity. A number of ICIs and ICI-based combinations have been approved for use in many solid and liquid malignancies, and intense research efforts promise to expand their role in advanced cancers and early-stage, curative-intent settings. While immunotherapy has become a pillar of cancer treatment and is considered safe, ICIs are associated with a spectrum of unique toxicities termed immune-related adverse events (irAEs). These irAEs can affect any organ system in the body, including the heart and cardiovascular system, occur at any point during or after treatment, and vary in presentation from mild to severe, and sometimes life threatening. Cardiac pathology attributed to irAEs include myocarditis, cardiomyopathy, pericardial disease, arrhythmias and conduction disease, impaired ventricular function with heart failure, and vasculitis. Autoimmune myocarditis is the most common and best characterized cardiac irAE to date. This activity, based on a PeerView Live Clinical Consults cardio-oncology symposium, provides essential guidance for prompt identification and initiation of treatment of irAEs. In the current era of cancer immunotherapy, healthcare professionals must develop a high level of vigilance and be able to correctly and rapidly manage and monitor patients with cancer exhibiting symptoms of possible cardiac irAEs to ensure the best possible outcomes. The expert faculty presents management algorithms, real-world case scenarios, and practical challenges related to multidisciplinary coordination of care to improve collaborative mitigation of cardiac irAEs. Upon completion of this activity, participants should be better able to: Review the prevalence, biologic mechanisms, burden, and consequences of the development of cardiac immune-related adverse events (irAEs) during or after treatment with cancer immunotherapies; Apply algorithms, practical tools, and available therapies based on the latest clinical evidence and recommendations for baseline risk assessment, identification, diagnosis/differential diagnosis, treatment, and management of cardiac irAEs; and Utilize effective shared decision-making and team-based approaches to facilitate multidisciplinary and interprofessional collaboration and improve clinician-patient communication and outcomes for patients at risk of or experiencing cardiac irAEs

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

Go online to PeerView.com/RGK860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Cancer immunotherapies in the form of anti–PD-1, anti–PD-L1, and anti–CTLA-4 immune checkpoint inhibitors (ICIs) have transformed the treatment of advanced and metastatic NSCLC without actionable genomic alterations, with a number of single-agent and combinatorial options available for clinical use. In light of demonstrably improved outcomes in the metastatic setting, ICIs are transitioning to earlier disease settings as part of perioperative neoadjuvant and/or adjuvant treatment strategies, which will likely result in reduced recurrence rates and more patients achieving cure. The number of available ICIs is expected to grow, as many new agents and combinations are in the final stages of testing, and novel checkpoints such as TIGIT and LAG-3 are showing promise in clinical trials. Consequently, predictive biomarker testing to refine treatment selection is paramount, and there is increasing focus on new surrogate endpoints to assess ICI efficacy, especially in early-stage settings where pathologic complete response, major pathologic response, and disease-free survival are helping to move the field forward faster. However, these exceptional advances are not without challenges. Not all patients with lung cancer benefit from ICIs, while others who could benefit do not have access to these therapies due to persistent disparities in biomarker testing, clinical care, and research. Determining the best immunotherapy option for each individual patient at the right time and in alignment with the particular needs and preferences of each patient is not simple and requires multidisciplinary collaboration and patient-centric shared decision-making. In addition, astute vigilance is required to mitigate potential immune-related adverse events (irAEs) to keep more patients benefiting from these therapies. This activity, based on a PeerView Live Seminars & Practicum educational event held at the 2022 ASCO Annual Meeting, provides guidance for navigating the evidence supporting the use of current and emerging immunotherapies throughout the NSCLC disease continuum and translating evidence to practice with the goal of improving patient outcomes in both advanced/metastatic and early-stage settings. Produced in partnership with LUNGevity Foundation, patient perspectives are also emphasized to improve team-based collaboration, patient engagement, shared decision-making, and health equity in clinical care and research. Upon completion of this activity, participants should be better able to: Describe the latest evidence supporting the use of current and emerging immune checkpoint inhibitors (ICIs) and combinations in locally advanced or metastatic and early-stage non–small cell lung cancer (NSCLC); Select the most appropriate ICI-based treatment for eligible patients with locally advanced/metastatic and early-stage NSCLC, considering the disease presentation, tumor characteristics, biomarker results, patient needs and preferences, current evidence and guidelines, multidisciplinary perspectives, and other relevant factors; Implement multidisciplinary and patient-centric approaches to ensure optimal and equitable use of immunotherapies in the care of all eligible patients with NSCLC; and Apply current guidelines and best practices for monitoring and management of immune-related adverse events (irAEs) in patients with NSCLC who are receiving or have received immunotherapy.

In this episode, Sandip Patel, MD shares his thoughts on optimizing immune checkpoint inhibitor (ICI) therapy in advanced non-small-cell lung cancer (NSCLC) and discusses best practices for individualizing therapy decisions and managing adverse events.Topics include:Currently approved ICIsRole of biomarker and PD-L1 testing in advanced NSCLCStrategies to individualize ICI treatment for patients with advanced NSCLCStrategies for identifying and managing immune-related adverse events in patients treated with ICIPresenter:Sandip P. Patel, MDAssociate ProfessorDepartment of MedicineDivision of Hematology/OncologyUniversity of California – San DiegoLa Jolla, California Link to full program:https://bit.ly/39vuCHC

In this episode, Beth Sandy, MSN, CRNP provides her thoughts on key data presented at the 2022 ASCO annual conference relating to immune checkpoint inhibitors in non-small cell lung cancer (NSCLC). Findings covered include:Survival results after 3 years from the phase III Checkmate 9LA study of nivolumab and ipilimumab combined with 2 cycles of chemotherapy vs chemotherapy in previously untreated advanced NSCLCUpdated survival and safety results after 5 years from the phase III Checkmate 227 study of nivolumab and ipilimumab vs chemotherapy in previously untreated advanced NSCLC, including assessment of a treatment-free intervalUpdated analysis from the phase III ATEZO-BRAIN trial of atezolizumab + carboplatin and pemetrexed in patients with advanced NSCLC with untreated brain metastases Updated overall response analysis from the phase II KEYNOTE-799 study of pembrolizumab with concurrent chemoradiation in unresectable, locally advanced stage III NSCLCResults from a phase II trial evaluating nivolumab plus ipilimumab vs nivolumab monotherapy following chemoradiation in unresectable stage III NSCLCPathological complete response results from the phase II NADIM II study of nivolumab and chemotherapy vs chemotherapy in the neoadjuvant NSCLC settingPresenter:Beth Sandy, MSN, CRNPNurse PractitionerAbramson Cancer CenterUniversity of PennsylvaniaPhiladelphia, PennsylvaniaLink to full program:https://bit.ly/39vuCHC

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

Go online to PeerView.com/MWV860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. With the recent approval of multiple novel therapeutics for patients with bladder cancer, oncology professionals have increased opportunities to improve outcomes in a variety of settings. However, not all patients are being given these promising new treatments. Management protocols often do not include the latest strategies, and clinicians often have several questions about incorporating these new agents, which include bladder-sparing options, immune checkpoint inhibitors, targeted therapies (FGFR inhibitors), and antibody-drug conjugates, into clinical practice. For instance, will the presence of immune-related adverse events (irAEs) in some patients linger after the end of therapy and limit the possible subsequent use of ADCs or FGFR inhibitors? To answer these questions, experts in bladder cancer highlight strategies for optimal care of patients in light of current evidence on and indications for use of immune, targeted, and antibody-based therapies and guidance on safely integrating these agents into treatment plans. Upon completion of this activity, participants should be better able to: Summarize the current roles, mechanisms of action, and key evidence pertaining to novel systemic therapies for patients with localized or metastatic bladder cancer, such as immunotherapies, small molecule targeted therapies, and antibody-drug conjugates, among others, Plan personalized treatment algorithms for patients with localized or metastatic urothelial cancer that incorporate novel and emerging therapies, updated guideline recommendations, and patient-, disease-, and treatment-specific factors, Implement evidence-based strategies and expert recommendations to prevent, mitigate and/or manage treatment-related adverse events that may occur among patients receiving novel systemic therapies for bladder cancer.

An interview with Dr. Lisa Carey from the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, NC, panel member on “Use of Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of High-risk, Early-stage Triple Negative Breast Cancer: ASCO Guideline Rapid Recommendation Update.” Dr. Carey discusses the updated recommendation on the use of pembrolizumab for patients with T1cN1-2 or T2-4N0 (stage II or III), early-stage triple negative breast cancer. For more information, visit, www.asco.org/breast-cancer-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/podcasts. My name is Brittany Harvey, and today I'm interviewing Dr. Lisa Carey from the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina, expert panel member on Use of Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of High-risk Early-stage Triple-negative Breast Cancer: ASCO Guideline Rapid Recommendation Update. Thank you for being here, Dr. Carey. Dr. Lisa Carey: It's a pleasure to be here, Brittany. Thank you! Brittany Harvey: Great! First, I like to note that ASCO takes great care in the development of its guidelines and ensures 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. Carey, do you have any relevant disclosures that are directly related to this guideline topic? Dr. Lisa Carey: I do not. Brittany Harvey: Thank you. Then what prompted this rapid update to the Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline, which was last published in 2021? Dr. Lisa Carey: You know, what prompted it where there were a number of changes that had come out, particularly things like the use of immune checkpoint inhibitors, and the adoption of the neoadjuvant strategy that really made us feel that these were overdue for practice guidelines. And in particular, there were some very important changes that came out early this year, particularly with the pembrolizumab use. Dr. Brittany Harvey: Great, so, based on these changes in the pembrolizumab use, what is the updated recommendation from the guideline panel? Dr. Lisa Carey: The recommendation actually is for patients who fulfilled the KEYNOTE-522 trial criteria. KEYNOTE-522 was a seminal trial in early triple-negative breast cancer, meaning, treatment-naive of the use of pembrolizumab incorporated into a chemotherapy-based regimen given neoadjuvantly, and then with the continuation of the immune checkpoint inhibitor pembrolizumab adjuvantly. This was important because we had been using, for a couple of years now, immune checkpoint inhibitors in PD-L1 positive or immune-activated triple-negative breast cancers in the metastatic setting. But we had not had evidence of improved survival or outcomes in early triple-negative breast cancer, so that's where KEYNOTE-522 comes in. This was a trial in which patients with early untreated triple-negative breast cancer, who fulfilled at least greater than T1N0, - and I want to make that pretty clear, this is a pretty broad net for early triple-negative breast cancer; the vast majority of triple negatives will be eligible for this treatment based on the population that was studied - and they receive four chemotherapy drugs, so, a taxane plus platinum, followed by an anthracycline-based regimen, either with or without pembrolizumab throughout the entire neoadjuvant course. They then went to surgery, and then they went on to receive adjuvant for another nine cycles, adjuvant pembrolizumab. The trial had already reported an improvement in pathologic complete response with the addition of the immune checkpoint inhibitor, which has also been seen with other immune checkpoint inhibitors. But what was reported a few months ago, and then published early this year, was the impact on event-free survival. So, there was a statistically significant improvement in event-free survival with the addition of pembrolizumab, which, at that point, it's a highly clinically meaningful endpoint, there are now two highly clinically meaningful endpoints. Both of these were the primary endpoints of this study. And so, it has rapidly been adopted on that basis for use and we felt because of that it needed to be addressed in a rapid update for helping clinicians interpret the data and use them effectively. Brittany Harvey: Understood, and I appreciate your work and the panel's work to rapidly interpret this data. So then, what should clinicians know as they implement this recommendation for the use of pembrolizumab? Dr. Lisa Carey: I think the key elements are unlike the metastatic setting, there's really no role for PD-L1 testing in the early triple-negative setting because the pembrolizumab seemed to improve outcomes regardless of PD-L1 status, which is a big difference from what's true in the metastatic setting where all of these immune checkpoint inhibitors seem to only benefit patients that are PD-L1 positive. So, it's kind of regardless of PD-L1 status. It's also true that in the KEYNOTE-522 study when they did do PD-L1 testing, most early triple negatives are PD-L1 positive. There really wasn't a subset of patients in the trial. And again, this is T2 or greater in tumor size or node-positive, who didn't seem to benefit from it. So, it's a pretty broad recommendation. The 'however' is that, as we all know at this point, when you add immune-directed therapies, you have a different set of toxicities you have to be aware of, specifically what they call immune-related adverse events or irAEs, which are, of course, essentially autoimmune. The thing that you have to remember is these can be permanent. These are frequently glandular disorders. Typically things like thyroid disease, which can be handled with replacement, but you can sometimes have colitis, myositis of different kinds, pneumonitis, and things like that. And some of these can be permanent. So, they have to be monitored very carefully. And ASCO has a guideline for managing irAEs and patients treated with immune checkpoint inhibitors - because again, we use these in lots of tumor types - that gives a lot of detailed practice recommendations, that clinicians should really consult frequently, not just in triple-negative, but in other disease types that we use these drugs. Brittany Harvey: Great. Thanks for explaining that aspect of the guideline. So then, you just mentioned that this recommendation is broadly applicable to many patients with early-stage triple-negative breast cancer. So, how will these guideline recommendations impact patients with early-stage triple-negative breast cancer? Dr. Lisa Carey: Well, it means that it's a totally new game. So, as you are evaluating a patient, first off, virtually all of these are treated neoadjuvantly now, except for the T1N0s, and pembrolizumab and the addition of pembrolizumab should be considered in all of them. Again, if they have, particularly organ-threatening autoimmune disorders themselves, they are a poor choice for these drugs, but otherwise, it should at least be considered. It's also true that there's been for many years a debate about the optimal chemotherapy to give in triple-negative breast cancer in the backbone that was used to which pembro was added had four drugs in it. And I think for that reason, that is considered the standard of care now. I do think one of the challenges for us moving forward is to decide if we need all of those drugs or not. I think a challenge for us also is to figure out who actually benefits from, again, these are five drugs, you know, a lot of therapy, a fair amount of toxicity. And so, I think that's a challenge going forward. Brittany Harvey: Thank you. And then finally, you just mentioned a couple of upcoming challenges, including the debate about the optimal chemotherapy regimen. But what are the outstanding questions regarding neoadjuvant therapy for patients with breast cancer? Dr. Lisa Carey: I think the outstanding questions regarding neoadjuvant therapy are one thing. I think neoadjuvant therapy, there isn't a lot of outstanding questions that are medically related other than what's the right backbone and things like that, because I think the neoadjuvant paradigm, if you're just purely talking about whether you're giving drugs before or after surgery, the drugs themselves tend to be the same because the key endpoint for the medical oncologist and for the patient, of course, is their outcome from a relapse standpoint. But it's also true that the neoadjuvant approach allows tailoring of the medical therapy. Like, in the past before we had immune checkpoint inhibitors, patients who received chemotherapy and had residual disease would get additional chemotherapy. That wasn't allowed in the KEYNOTE study. So, I think many people, because patients with residual disease in KEYNOTE, still had pretty poor outcomes are incorporating additional chemotherapy, specifically adjuvant capecitabine with the pembrolizumab, but there's no data for that. So, I think that's a challenge that we do have to address. I think the other challenge is simply surgical management: whether we can use these improved pathologic response and clinical response outcomes to minimize some of the local therapies, in addition to tailoring the medical therapies. Brittany Harvey: Great! Well, we look forward to maybe tackling some of these challenges when we have more data in upcoming guidelines. I want to thank you so much for your time to rapidly update these guideline recommendations and for your time speaking with me today, Dr. Carey. Dr. Lisa Carey: It's my pleasure. Thank you so much, Brittany. Brittany Harvey: Thank you to all of our listeners for tuning in to the ASCO Guidelines Podcast Series. To read the full guideline go to www.asco.org/breast-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO guidelines app available 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 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.

Go online to PeerView.com/KKF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Patients with cancer often present to the ED in an acutely ill state with complications from their cancer or treatments used, but a broadening use of a new class of cancer immunotherapies has changed the types of complications experienced by these patients. This spectrum of unique toxicities, termed immune-related adverse events (irAEs), is less well known, and commonly, they are overlooked, misdiagnosed, and not appropriately managed in ED settings. Standard algorithms for diagnosis and treatment no longer apply, as irAEs require a distinct approach. Are you prepared to handle the new category of oncologic emergencies you are likely to increasingly encounter in your ED? This activity will help you get up to date and change your practice. Emergency medicine and oncology experts will join forces to provide practical, case-based guidance for timely and accurate recognition, triage, diagnosis, and management of irAEs associated with novel immunotherapies in patients with cancer who present to the ED. Upon completion of this CE activity, participants will be able to: Review the biologic reasons and mechanisms that drive the development of immune-related adverse effects (irAEs) during or after treatment with cancer immunotherapies, Describe the spectrum of irAEs associated with immune checkpoint inhibitors and combinations, including those most likely to be encountered by emergency medicine (EM) professionals in the emergency department (ED), Implement latest recommendations for identification, assessment, diagnosis/differential diagnosis, and management of irAEs in ED settings, Integrate team-based approaches to triage, evaluate, diagnose, and manage pertinent irAEs in the ED in collaboration with oncology professionals.

Go online to PeerView.com/KKF860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Patients with cancer often present to the ED in an acutely ill state with complications from their cancer or treatments used, but a broadening use of a new class of cancer immunotherapies has changed the types of complications experienced by these patients. This spectrum of unique toxicities, termed immune-related adverse events (irAEs), is less well known, and commonly, they are overlooked, misdiagnosed, and not appropriately managed in ED settings. Standard algorithms for diagnosis and treatment no longer apply, as irAEs require a distinct approach. Are you prepared to handle the new category of oncologic emergencies you are likely to increasingly encounter in your ED? This activity will help you get up to date and change your practice. Emergency medicine and oncology experts will join forces to provide practical, case-based guidance for timely and accurate recognition, triage, diagnosis, and management of irAEs associated with novel immunotherapies in patients with cancer who present to the ED. Upon completion of this CE activity, participants will be able to: Review the biologic reasons and mechanisms that drive the development of immune-related adverse effects (irAEs) during or after treatment with cancer immunotherapies, Describe the spectrum of irAEs associated with immune checkpoint inhibitors and combinations, including those most likely to be encountered by emergency medicine (EM) professionals in the emergency department (ED), Implement latest recommendations for identification, assessment, diagnosis/differential diagnosis, and management of irAEs in ED settings, Integrate team-based approaches to triage, evaluate, diagnose, and manage pertinent irAEs in the ED in collaboration with oncology professionals.