Podcasts about sidney kimmel cancer center

Dr. Allison Zibelli and Dr. Erika Hamilton discuss the results of the DESTINY-Breast06 trial in HR+, HER2-low and HER2-ultralow metastatic breast cancer and the A-BRAVE trial in early triple-negative breast cancer, the results of which were both presented at the 2024 ASCO Annual Meeting. TRANSCRIPT Dr. Allison Zibelli: Hello, I'm Dr. Allison Zibelli, your guest host of the ASCO Daily News Podcast. I'm an associate professor of medicine and breast medical oncologist at the Sidney Kimmel Cancer Center of Jefferson Health in Philadelphia. My guest today is Dr. Erika Hamilton, a medical oncologist and director of breast cancer research at the Sarah Cannon Research Institute. We'll be discussing the DESTINY-Breast06 trial, which showed a progression-free advantage with the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) compared to chemotherapy in hormone receptor-positive HER2-low or HER2-ultralow metastatic breast cancer. We'll address the implications of this study for the community, including the importance of expanding pathology assessments to include all established subgroups with HER2 expression, and the promise of expanding eligibility for antibody-drug conjugates. We'll also highlight advances in triple-negative breast cancer, focusing on the A-BRAVE trial, the first study reporting data on an immune checkpoint inhibitor avelumab in patients with triple-negative breast cancer with invasive residual disease after neoadjuvant chemotherapy.  Our full disclosures are available in the transcript of this episode.  Erika, it's great to have you on the podcast today. Dr. Erika Hamilton: Thanks so much, Allison. Happy to join. Dr. Allison Zibelli: Antibody-drug conjugates are rapidly changing the treatment landscape in breast cancer. The data from the DESTINY-Breast06 trial suggests that trastuzumab deruxtecan may become a preferred first-line treatment option for most patients with HER2-low or HER2-ultralow metastatic breast cancer after progression on endocrine therapy. First, could you remind our listeners, what's the definition of HER2-ultralow and what were the findings of this trial? Dr. Erika Hamilton: Yeah, those are fantastic questions. Ultralow really has never been talked about before. Ultralow is part of a subset of the IHC zeros. So it's those patients that have HER2-tumor staining that's less than 10% and incomplete but isn't absolutely zero. It's even below that +1 or +2 IHC that we have classified as HER2-low. Now, I think what's important to remember about D-B06, if you recall, D-B04 (DESTINY-Breast04) was our trial looking at HER2-low, is that D-B06 now included HER2-low as well as this HER2-ultralow category that you asked about. And it also moved trastuzumab deruxtecan up into the frontline. If you recall, D-B04 was after 1 line of cytotoxic therapy. So now this is really after exhausting endocrine therapy before patients have received other chemotherapy. And what we saw was an improvement in progression-free survival that was pretty significant: 13.2 months versus 8.1 months, it was a hazard ratio of 0.62. And you can ask yourself, “well, was it mainly those HER2-low patients that kind of drove that benefit? What about the ultralow category?” And when we look at ultralow, it was no different: 13.2 months versus 8.3 months, hazard ratio, again, highly significant. So I think it's really encouraging data and gives us some information about using this drug earlier for our patients with hormone receptor-positive but HER2-negative disease.  Dr. Allison Zibelli: I thought this study was really interesting because it's a patient population that I find very difficult to treat, the hormone receptor-positive metastatic patient that's not responding to endocrine therapy anymore. But it's important to mention that T-DXd resulted in more serious toxicities compared to traditional chemotherapy in this study. So how do you choose which patients to offer this to? Dr. Erika Hamilton: Yeah, those are both great points. So you're right, this is after endocrine therapy. And in fact, about 85% of these patients had received at least 2 prior lines of endocrine therapy. So I have some people kind of asking, “Well, if endocrine therapy really isn't benefiting everyone in the second-line setting post-CDK, should we just move to the ADCs?” And, no, probably we should really make sure that we're exhausting endocrine therapies for those patients that are going to benefit. And once we determine somebody has endocrine-resistant disease, that's when we would think about switching. In terms of the side effects, I think you're right. It's mainly ILD that's probably the more serious side effect that we worry about a little bit with trastuzumab deruxtecan. The good news is, through multiple trials, we've gotten a little bit better at managing this. We've pretty much all but eliminated any fatal cases of ILD, definitely less than 1% now. ILD rates, depending on what study you look for, kind of ranges in that 10% to 15% range. Any grade ILD on D-B06 was 11.3%. So really kind of making sure that we look for ILD at scans, making sure that patients are educated to tell us about any new pulmonary symptoms: cough, exertional dyspnea, shortness of breath at rest, etc. But I think the most common side effects that we really deal with on a daily basis with trastuzumab deruxtecan, luckily, is nausea, which we've gotten better at managing with the 2- or 3-drug antiemetic regimen, and probably a little bit of fatigue as well. Dr. Allison Zibelli: Thank you. So, I think for most people in the community, the sticking point here will be expanding pathology assessments to include all of the subgroups, including the ultralow. Most patients in the community are not testing for HER2-low and HER2-ultralow now. Dr. Erika Hamilton: Historically, we kind of all did HER2 IHC, right? And then as FISH became available, there were a lot of institutions that moved to FISH and maybe didn't have IHC anymore. And now, at least in my institution, we do both. But I think it's a very important point that you made that IHC was really designed to pick out those patients that have HER2-high, the 3 pluses or the FISH amplified cases. It was not to tell the difference between a 1+ or a 2+ or a 0 that's not quite a 0 and a 1+. So I think you're right. I think this is tough. I probably have a little bit more of an interesting take on this than some people will. But data from ASCO, not this year but in 2023, there was actually a pretty eloquent study presented where they looked at serial biopsies in patients, and essentially, if you got up to 4 or 5 biopsies, you were guaranteed to have a HER2-low result. Now, this didn't even include ultralow, which is even easier. If we know we include ultralow, we're really talking about probably 85% to 90% of our patients now that have some HER2 expression. But if we biopsy enough, we're guaranteed to get a HER2 low.  And so I think the question really is, if we know IHC wasn't really designed to pick out these ultralows, and we know kind of greater than 90% of patients are going to have some expression, did we kind of develop this drug a little bit backwards? Because we thought we understood HER2, and the reality is this drug is a little bit more like a sacituzumab govitecan, where we don't test for the TROP2. Should we really be kind of serial biopsying these patients or should maybe most patients have access to at least trying this drug?  Dr. Allison Zibelli: So I don't think that most of my patients will really be happy to sign up for serial biopsies. Dr. Erika Hamilton: Agreed. Dr. Allison Zibelli: Do we have any emerging technologies for detecting low levels of HER2? You talked about how the IHC test isn't really designed to detect low levels of HER2. Do you think newer detection techniques such as immunofluorescence will make a difference, or will we have liquid biopsy testing for this? Dr. Erika Hamilton: Yeah, I think liquid biopsy may be a little bit hard, just because some of those circulating tumor cells are more of a mesenchymal-type phenotype and don't necessarily express all of the same receptors. Normally, if they're cytokeratin-positive, they do, but certainly there is a lot out there looking at more sensitive measures. You mentioned immunofluorescence, there are some even more quantitative measures looking at lower levels of HER2. I definitely think there will be. I guess, ultimately, with even the IHC zeros that are the less than 10% incomplete staining, having a PFS that was absolutely no different than the HER2 low, I guess the question is, how low can we really go? We know that even the IHC zeros doesn't mean that there's no HER2 expression on the cell surface. It just means that maybe there's a couple of thousand as opposed to 10,000 or 100,000 copies of HER2. And so it really appears that perhaps this drug really is wedded to having a lot of HER2 expression. So ultimately, I wonder how much we're going to have to use those tests, especially with what we know about tumor heterogeneity. We know that if we biopsy 1 lesion in the liver, biopsy a lymph node, or even another lesion in the liver, that the HER2 results can have some heterogeneity. And so ultimately, my guess is that most people have some HER2 expression on their breast cancer cells. Dr. Allison Zibelli: So maybe we're going to be using this for everybody in the future. Dr. Erika Hamilton: It certainly seems like we keep peeling back the onion and including more and more patients into the category that are eligible to receive this. I agree. Dr. Allison Zibelli: Let's move on to triple-negative breast cancer, namely the A-BRAVE trial. This was an interesting trial for patients that did not get neoadjuvant immunotherapy and testing 2 groups. The first group was those with residual disease after neoadjuvant conventional chemotherapy. The second group was people with high-risk disease identified upfront that had upfront surgery. The study found that adjuvant avelumab did not improve disease-free survival versus observation, which was the study's primary endpoint. But interestingly, there was a significant improvement in 3-year overall survival and distant disease-free survival. Can you give us your thoughts on that? Dr. Erika Hamilton: Yeah, I think this study was really interesting. Right now, the standard for our patients with larger or node-positive triple-negative cancers is KEYNOTE-522. It's a pretty tough regimen. It's kind of 2 sequential uses of 2 chemotherapies, so 4 chemotherapy agents total with pembrolizumab. But you're right, this study looked at those that had residual disease after neoadjuvant that didn't include immunotherapy, or those patients that didn't get neoadjuvant therapy, went to surgery, and then were receiving chemotherapy on the back end. I'm going to give you the numbers, because you're right. The 3-year disease-free survival rates were not statistically significant. It was 68.3% among those that had avelumab, 63.2% with those that had observation only. So the difference was 5.1% in favor of avelumab, but it wasn't statistically significant. A p value of 0.1, essentially. But when we looked at the 3-year overall survival rates, we saw the same pattern, those patients with the avelumab doing better, but it was 84.8% overall survival and not, unfortunately, dying, versus 76.3%. So the magnitude of benefit there was 8.5%, so about 3% higher than we saw for disease-free survival, and this was statistically significant.  So is this going to change practice for most patients? I probably don't think so. I think for our patients that have larger tumors that's recognized upfront or have node positivity, we're probably going to want to use neoadjuvant chemo. Being able to get a PCR is very prognostic for our patients and enables us to offer things on the back end, such as PARP inhibitors or further chemotherapy of a different type of chemotherapy. But for our patients that go to surgery and maybe the extent of their disease just isn't recognized initially, this could be an option. Dr. Allison Zibelli: I agree. I think this will be a really useful regimen for patients where we get the surprise lymph node that we weren't expecting, or somebody who comes to us, maybe without seeing the medical oncologist, who got upfront surgery. So I thought this was really interesting. What kind of translational studies do you think we're going to do to try and understand which patients would benefit from avelumab? Dr. Erika Hamilton: Yeah, I think that's a great question, and honestly, it's a question that we haven't really answered in the neoadjuvant setting either. Immunotherapy in breast cancer is just a little bit different than it is in some other diseases. We have a benefit for those patients that are PD-L1 positive in the first line. We really haven't seen benefit for metastatic outside of first line. And then in neoadjuvant, it was among all comers. We don't have to test for PD-L1. And now we have this avelumab data from A-BRAVE. I think the question is, is there's probably a subset of patients that are really getting benefit and a subset that aren't. And I don't know that PD-L1 testing is the right test. We know a lot of people are looking at TILs, so kind of lymphocytes that are infiltrating the tumor, a variety of other kind of immunologic markers. But my guess is that eventually we're going to get smart enough to tease out who actually needs the immunotherapy versus who isn't going to benefit. But we're not quite there yet. Dr. Allison Zibelli: Thank you, Erika, for sharing your valuable insights with us on the ASCO Daily News Podcast today. Dr. Erika Hamilton: Thanks so much for having me.  Dr. Allison Zibelli: And thank you to our listeners for joining us. You'll find the links to all the abstracts discussed today in the transcript of this episode. Finally, if you like this podcast and you value our insights, please take a moment to rate, review, and subscribe wherever you get your podcasts. It really helps other people to find us. So thank you very much for listening today.   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. 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.    Find out more about today's speakers:  Dr. Allison Zibelli Dr. Erika Hamilton @ErikaHamilton9   Follow ASCO on social media:  @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn      Disclosures: Dr. Allison Zibelli:  None Disclosed   Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson   Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics

Dr Gregory Garber, Administrative Director for the Division of Supportive Oncology at the Sidney Kimmel Cancer Center at Jefferson Health, discusses mental health, yours and your care circle's, at and after a cancer diagnosis.  Dr. Garber talks about how you cope with cancer, during and after treatment, has a big impact on your mental health, and should be part of your overall care plan.  He discussed the National Institute of Health 2007 mandate adding the psycho-social aspects of a cancer diagnosis within their proscribed treatment.   We discussed ‘attitude' and patient outcomes and that, generally speaking, your personality and coping ability will not change with a diagnosis of cancer.  Can your attitude affect your outcome?  He notes, despite popular belief, research has been inconclusive. “There is really no good evidence that one's attitude impacts how long they're going to live after a cancer diagnosis or what their response to treatment will be.”  If you were a gloomy person before your illness, you'll come through just as morose.  If you are perpetually perky with a sunny disposition, you'll take your bad news and treatment with the same cheerful outlook. “There are entirely miserable people who go through breast cancer or any kind of cancer treatment, and they do fine,” he continued.  “And, there are wonderful Pollyanna folk who go through it and do fine.”    What IS affected by attitude is your quality of life during the treatment.  That's where your personality and coping skills can make a difference in how you do.  Learn to recognize your ‘triggers' – the situations that cause you stress, then experiment and combine coping methods to find what works best for you.  Prioritizing your needs and time by making a schedule can help you feel less overwhelmed by the demands on your limited energy.  Take a break for deep breathing, meditation and gradual muscle relaxation.  Get back to daily exercise, as soon as you can, doing what you can.  Eating well and getting enough sleep have a huge impact on your mental well-being.  While it can be rough during cancer therapy, making the effort then will make it easier to follow good habits after treatment has ended.   Finally, talk to someone. If it's affecting your relationships or your ability to work or parent, your ability to sleep or enjoy your daily activities, call your healthcare provider, or reach out to the America Cancer Society, they offer free online groups for patients with different diagnosis and at different points of treatment. The National Institute of Health, NAMI and Living Beyond Breast Cancer also offer peer-based support.  

Dr. Allison Zibelli and Dr. Megan Kruse discuss the potential benefit of endocrine therapy in ER-low breast cancer; the efficacy and tolerability of triplet therapy in PIK3CA-mutated, HER2-negative locally advanced or metastatic breast cancer; and more key research that will be featured at the 2024 ASCO Annual Meeting.  TRANSCRIPT Dr. Allison Zibelli: Hello, I'm Dr. Allison Zibelli, your guest host of the ASCO Daily News Podcast today. I am an associate professor of medicine and a breast medical oncologist at the Sidney Kimmel Cancer Center of Jefferson Health in Philadelphia. My guest today is Dr. Megan Kruse, a breast medical oncologist and director of breast cancer research at the Cleveland Clinic Taussig Cancer Institute. We'll be discussing key abstracts in breast cancer that will be featured at the 2024 ASCO Annual Meeting.  Our full disclosures are available in the transcript of this episode, and disclosures related to all episodes of the podcast are available at asco.org/DNpod.  Megan, it's great to have you back on the podcast. Dr. Megan Kruse: Thanks, Alison. Happy to be here. Dr. Allison Zibelli: So, let's begin with Abstract 505. This was another analysis of the SWOG S1007 (RxPONDER) trial, which was the trial that was looking at premenopausal women with intermediate risk oncotype scores. And do they benefit from chemotherapy? If you analyze the whole group, they do benefit from chemotherapy, but what this study questions is whether we can pull out the subset of these patients that actually benefit from chemotherapy? And what they tried doing was measuring various endocrine reproductive hormones and found that anti-mullerian hormone over 10 was the only one that predicted for chemotherapy benefit. What are your key takeaways from this study? Will it help us figure out who is truly postmenopausal biochemically? Dr. Megan Kruse: I think this is really promising. This is one of the toughest situations in clinic, honestly, when you have a premenopausal woman who has an intermediate oncotype risk. We know that chemotherapy is not going to make a huge difference potentially in their breast cancer outcomes, but it may add to some small differential benefit. I think that many of our patients are really afraid about leaving any impactful therapy on the table. And so, it'd be nice to have another marker to help sort out who in this group will really benefit. And the AMH levels, I think, are something that are very accessible for most practices, easily orderable. And it seems like this cutoff of 10 is a very well-known cut point in the AMH interpretation, and a pretty clear-cut point. So, I think it gives a little bit more objective view of who may actually benefit or not.  When you look at the results shown in this abstract, for the women in the recurrence score less than 25 receiving chemotherapy followed by endocrine therapy, they had a benefit in five-year invasive disease-free survival of 7.8%. When you look at those oncotype reports and they suggest how much benefit you might get, that's right around the same number you see. So, I think that's supporting that this is the subgroup that's benefiting.  When you look at those patients with AMH less than 10, they actually had a negative 1.7% difference in overall survival. So, you wonder, are we harming these patients by giving them chemotherapy? I think that's too far of a stretch to say. I wouldn't be worried about harm. But hopefully, we can stop giving chemotherapy to patients who truly are not going to benefit if we have an additional biomarker of response. That's what the promise is for this.  So again, another potentially actionable abstract that we can put into practice pretty quickly. It's going to be hard to know how to use this, also in the context of the upcoming OFSET study or BR009, which is of course the study in the same group of premenopausal patients with node-negative or 1-3 lymph nodes involved, and intermediate oncotype scores, randomizing them to endocrine therapy with ovarian suppression versus chemoendocrine therapy. It would be kind of nice to see the AMH levels incorporated into that model to see if the same trend holds true. But I think we go back to the TAILORx and RxPONDER studies many times as good quality data, and the trend here is really striking.  Dr. Allison Zibelli: I really like this study because one of the things I often struggle with in the clinic as a practicing breast oncologist is who's really in menopause. And we end up having these fights with the gynecologists where sometimes our opinions differ. And it would be really nice to have something this clear cut to say, “You're in biochemical menopause or you're not.” So, I look forward to seeing this used in a lot of different ways in the future.  Dr. Megan Kruse: Yeah, I agree. And I think it's based on the other markers we have with estrogen levels, with FSH levels. If you're checking those sequentially in patients, we know they go up and down, and it's really hard to tell what we are capturing at this single point in time. And maybe that's what we're seeing in this analysis is that the AMH is a little bit more stable and reliable marker. So, I really love that. And I don't know about you, but in clinical practice it can be really hard. A lot of our patients have had uterine ablations or hysterectomies but have intact ovaries. And so, figuring out ovarian function status is actually much, much harder than it may seem superficially.  Dr. Allison Zibelli: Okay, so let's focus on Abstract 513. I thought this was really interesting. It's a group of patients that we don't have much data for, and that's women that are ER-low, with an ER of 1% to 10% in early-stage breast cancer. Right now, national guidelines are sort of on the fence about whether these women benefit from endocrine therapy. So that's what this study tried to focus on. How will this study change how we approach this group of patients? Dr. Megan Kruse: This study really gave me pause and made me rethink what I'm doing on a day-to-day basis, because here, what the authors found in a very large NCDB analysis was that for women with ER-low status, so ER 1% to 10% positive, they actually did have benefit receiving endocrine therapy, it seems. What they found, after you adjust for many other confounding factors like age, comorbidity, and PR status, is that patients with ER-low breast cancer when they did not receive endocrine therapy actually had worse overall survival outcomes with a hazard ratio of around 1.2 to 1.3.  This is a group where I have typically not pushed endocrine therapy very strongly. I think the patients, especially now, are receiving such intense therapy with chemoimmunotherapy in the preoperative setting, by the time they reach their adjuvant phase with immunotherapy, maybe with capecitabine, maybe with a PARP inhibitor, endocrine therapy seems, “Oh, why bother after we've done all of this?” And we know that the toxicities of endocrine therapy are real and can be very problematic. And so, I have often felt like it's the least important part of therapy and questioned whether we should even bother. But I think this analysis really challenges that and makes us think twice. And I think it speaks to a theme that we're seeing more and more about the heterogeneity of these breast cancer subtypes. And again, talking about clear-cut points in analysis, nothing is truly black and white. So maybe that little bit of expression does mean something.   It does kind of stand in contrast to what we see in studies of ER-low behaving a bit more triple-negative like, but maybe they're their own category, and maybe it gives us a place to look for other therapy synergy in the future. But it certainly will make me stop and think again when I see a ER 4% patient. Should I talk to them about endocrine therapy?  Dr. Allison Zibelli: Yeah, I totally agree with everything you said there. And we know that this is a biologically different group of patients than the ER strongly positive group, but maybe not as different as we once thought. Dr. Megan Kruse: Yeah. And I think there's still a lot of unknowns here about what if they're ER truly negative and PR a little bit positive. So, these clinical situations don't come up that frequently, but when they do, they're humbling, because I think we really, as much data as we have in breast cancer, it's pretty limited for these types of patients.  Dr. Allison Zibelli: So, let's move on to Abstract 1003, which was a new combination in the INAVO120 trial. It was palbociclib plus fulvestrant with either inavolisib or placebo in patients with PIK3CA-mutated hormone receptor-positive, HER2-negative, locally advanced metastatic breast cancer in the second line, who relapsed within 12 months of adjuvant endocrine therapy completion. This is a big group of patients for us. Can you tell us about the study? And does this triple therapy, in your mind, represent a new standard of care? Dr. Megan Kruse: Yeah, this study was initially presented at our 2023 San Antonio Breast Cancer Symposium, and there I felt like it was a little bit of a surprise. There's been so much talk about PI3K-AKT-PTEN pathway impactful drugs and targetable mutations. We've heard a lot about alpelisib and capivasertib, and how these drugs are fitting into our practice. Then all of a sudden, we have this data with inavolisib that I wasn't really expecting to see. And perhaps I think one of the reasons that this study came about so suddenly, seemingly, and so quickly is because it looks at a really high-risk patient population. And so, these are those patients that are having relapses of their breast cancer within their initial, while on adjuvant AI therapy or within 12 months of stopping. And so, having a marker of this patient group that is developing, I think, early endocrine resistance and it's another space where it's kind of hard to identify who these patients are upfront. And so their response to therapy tends to be one of the best markers of risk moving forward.   So, when this trial was originally presented, what was quite striking is that the progression-free survival was more than doubled for the triplet combination compared to the control arm. And those numbers were PFS of 15 months versus 7.3 months for the triplet versus the control. The response rate was also significantly improved, with the triplet going above 50%, versus a response rate in the control of about 25%. So, the results were really striking. But they clearly come with some caveats, which are that this is a very defined patient population of risk. Of course, they have to have the biomarker of a PIK3CA mutation, and in the control arm here, there was no PIK3-targeted medication. And so you wonder, are we just getting better results by including that more specific targeted therapy earlier on? It's hard to know, but I think that could certainly be a big part of this.  And the other caveat, when I'm looking at the data, is how might we think about this in our real population? Because as we know, drugs that impact this pathway tend to have a lot of toxicity concerns, primarily hyperglycemia, diarrhea, and rash. And with this particular agent, there was also notable stomatitis, which is something we've seen with everolimus, of course, in this pathway, but not maybe as much with alpelisib and capivasertib. When you're thinking about all of those toxicities, keep in mind that this trial population included patients with a pretty tight fasting blood sugar requirement, A1c of less than 8, and not requiring insulin. So all of that being said, I think this combination seems really intriguing for efficacy. This is a patient population I'm worried about, because we know that these patients are likely not going to get the same upfront benefit of CDK4/6 inhibitor-based therapy, like maybe we see for a patient with long disease-free survival or de novo metastatic breast cancer. But I think it's going to have some meaningful issues in clinic regarding tolerability. And then, of course, the regimen is more complex. We're talking about two different oral agents and an intramuscular injection, which could be hard for some patients, and it's going to have some decent financial toxicity associated with it.  So, I think it's really, really exciting and has the potential to make an impact in first-line therapy. But I don't envision it being the standard of care first-line therapy for everyone, particularly in light of some of the other data we have in the first line questioning, like from the SONIA trial, how important is CDK for everyone? Again, this is I think where we're starting to get subsets within subsets of this first-line patient population of who needs escalation of therapy and who may benefit from more de-intensified therapy. Dr. Allison Zibelli: I agree, these agents have significant toxicity, and especially financial toxicity is something that we at the academic setting frequently forget about because a lot of our patients are on trials. So, it will be interesting to figure out how we're going to use these agents in real life.  So, for our final abstract, I wanted to discuss Abstract 10508, which was a prevention trial. I think pretty much everybody's patients are going to be asking them about this because it's about GLP-1 inhibitors. We know that bariatric surgery does prevent obesity-associated cancers. This study explored whether the GLP-1 agonists could offer a similar result to bariatric surgery in patients with BMIs over 35. What do you think about this study?  Dr. Megan Kruse: I thought this was such an interesting and timely study and question. These drugs are out there – Ozempic, Mounjaros, and Wegovy – and our patients ask about them. And I think there has been a lot of interest for years now about the impact of lifestyle factors on cancer incidence, particularly in breast cancer, where we know that obesity does seem to be related to cancer incidence. And with all of our concerns about hormonal exposure and extra weight, extra adipose tissue being a source of potential extra estrogen, this is a really key topic.   Talking about financial toxicity, again, I think that is honestly probably the bigger hurdle because this study does reinforce that patients who are receiving GLP-1 receptor antagonists and those who have had bariatric surgery do benefit in terms of cancer-related survival and all-cause related survival. So, I think the impact on metabolic factors is making a difference in cancer incidence and outcomes. But access and equity will be the big issue here, right? Dr. Allison Zibelli: Yes. Dr. Megan Kruse: Can we get patients on these drugs? I certainly have had patients with a history of breast cancer who have been on these medications, and they have done great with them in terms of weight loss. We know that our therapies, many times, do have the side effect of weight gain. So, I wonder if there is a part of weight management that maybe we haven't talked about so much as oncologists that we need to talk about moving forward and would be very welcome by our patients. But it'll have its own caveats, of course. Not only the financial issue but there's the durability issue. And I think when you look at the degree of impact of these medications versus bariatric surgery, you do see a greater impact from bariatric surgery, in not only the degree of weight loss but also the sustainability of that weight loss. So, I think for the right patient at the right time, bariatric surgery may still be the better option, but that's not going to be an option for a lot of patients. It is a huge shift in lifestyle and medications and many ways might be easier, so more to come.   I also wonder about looking at this data through the lens of different cancer types. What will we find out? Is the trend for colon cancer going to be different from the trend for breast cancer? Will the trend within breast cancer be different for breast cancer subtypes? I would very much welcome more data in this space, and it is nice to see a first step forward. Dr. Allison Zibelli: I thought the most interesting thing about this study was that while bariatric surgery patients lost more weight, GLP-1 patients had a higher decrease in obesity-related cancer risk. So, it shows to me that there is something beyond just weight. It is something in metabolism that is driving these cancers.  Dr. Megan Kruse: Yes, and I think that that goes back to some things we have thought about for a long time with insulin levels and insulin-like growth factor, and all of these things that I think when our patients look at more metabolic approaches to cancer control, this is probably what we are trying to get at. We have just never had great ways to measure it or influence it, and perhaps now we finally do. I would love to see some partnering work here in the future with oncologists and endocrinologists and digging into these patients who have great responses to see what we are actually seeing at the hormone level. Dr. Allison Zibelli: Well, thank you so much, Megan, for your great insights today on the ASCO Daily News Podcast. We really appreciate you coming to talk with us again. Dr. Megan Kruse: Thank you. It has been a great conversation. Thank you for opening my eyes to these abstracts, and I am happy to see what else ASCO brings. Dr. Allison Zibelli: And thank you to our listeners for joining us today. You will find links to all the abstracts we discussed today in the transcript of this episode. Finally, if you value the insights you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. It really helps other people find us. Thank you for listening.   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. The 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.   Follow today's speakers: Dr. Allison Zibelli Dr. Megan Kruse @MeganKruseMD   Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn   Disclosures: Dr. Allison Zibelli: None Disclosed   Dr. Megan Kruse: Consulting or Advisory Role: Novartis Oncology, Puma Biotechnology, Immunomedics, Eisai, Seattle Genetics, Lilly

Joining us on the Faculty Factory Podcast this week is Elizabeth M. Jaffee, MD, FAACR, FACP, FAAAS, FAIO, highlighting the importance of reciprocal mentorship in academic medicine where both mentor and mentee contribute and grow. In addition to her role as a prolific mentor, Dr. Jaffee is the Dana and Albert “Cubby” Broccoli Professor of Oncology, the Deputy Director of the Sidney Kimmel Cancer Center at Johns Hopkins, the Co-Director of the Gastrointestinal Cancers Program, and the Inaugural Director of the Cancer Convergence Institute. Encouraging empowerment, Dr. Jaffee prompts mentees to actively engage, bringing forth their own agendas and aspirations. Beyond institutional confines, Dr. Jaffee actively seeks opportunities to inspire and guide others, finding joy in witnessing their growth. Navigating the responsibilities of research and mentorship, she tackles academic challenges with a dedication to nurturing talent. Her approach serves as a beacon for aspiring mentors and mentees alike, promoting honest communication, proactive engagement, and the celebration of everyone's unique journey. Programming Reminder As of April 2024, our podcast has amassed nearly 92,000 total downloads and YouTube views from listeners across 95 countries. The Faculty Factory website has garnered over 42,000 web visits from users spanning 122 countries. Truly an international platform, we extend an invitation to you, or someone you believe our academic medicine community should hear from, to join us as a guest on the show. Visit the Contact Us page on FacultyFactory.org to send us a message or reach out directly to our host, Dr. Skarupski, at kskarupski@jhmi.edu.

It's time to get the 411 on 420 and learn about how Cannabis is helping cancer patients from alleviating pain to curbing anxiety. Avi Grant-Noonan and Samantha Russell both #CervicalCancer #Cervivors share their experiences with using cannabis and how it has changed their lives for the better. Dr. Brooke Worster a clinician-researcher, practicing Supportive Medicine and cancer pain management for cancer patients at the Sidney Kimmel Cancer Center, breaks down the stigma of using cannabis for cancer patients, including the history and the various cannabis products.  Remember, your health is your priority, and seeking information is a crucial step in your journey.  Did you connect with this episode? Share your thoughts with us on social media using #CervivorPodcast or by emailing us.   For more Cervivor-related content, check out: Cervivor.org. Follow Cervivor on all social media platforms. If you would like to be interviewed as a potential guest for an upcoming episode or would like to request a speaker or topic for a future podcast episode, email us at info@cervivor.org. --- Support this podcast: https://podcasters.spotify.com/pod/show/cervivor/support

Increasing diversity in the field of oncology is an ongoing task. Our next guest has made it her mission to increase those ranks as well as becoming the first African American woman to be a Brigadier General in the US Air Force. Dr. Edith Mitchell describes her early years growing up in rural Tennessee (2:52), the motivation for joining the Air Force in the 70's (7:33) and strategizing to increase ethnic diversity in medicine and oncology (16:53). Speaker Disclosures Dr. David Johnson: Consulting or Advisory Role – Merck, Pfizer, Aileron Therapeutics, Boston University Dr. Patrick Loehrer: Research Funding – Novartis, Lilly Foundation, Taiho Pharmaceutical Dr. Edith Mitchell: Leadership – Corvus; Honoraria - Sanofi, Exelixis; Consulting or Advisory Role Company - Genentech, Novartis, Merck, Bristol Myers Squib; Speakers' Bureau – Ipsen; Research Funding Company - Genentech, Sanofi  Resources (related podcasts, courses or articles) If you liked this episode, please follow the show. To explore other educational content, including courses, visit education.asco.org. Contact us at education@asco.org. TRANSCRIPT  Disclosures for this podcast are listed on the podcast page.   Pat Loehrer:  Welcome to Oncology, Etc., an ASCO Education Podcast. I'm Pat Loehrer, Director of Global Oncology and Health Equity at Indiana University.  Dave Johnson: And I'm Dave Johnson, a Medical Oncologist at the University of Texas Southwestern in Dallas. If you're a regular listener to our podcast, welcome back. If you're new to Oncology, Etc., the purpose of the podcast is to introduce our listeners to interesting and inspirational people and topics in and outside the world of oncology. Pat Loehrer: Imagine knowing in your heart what you wanted to be in life. It usually takes people decades to figure that out, but our next guest knew at age three that she wanted to be a doctor and, later in high school, to be an oncologist. She's achieved much in her lifetime and has incorporated the "pay it forward" by mentoring many others. Dave Johnson: Our guest today is Dr. Edith Mitchell. I first met Edith over 40 years ago when we were both starting out our careers as junior faculty. She grew up in rural Tennessee, and as Pat mentioned, remarkably, she chose a career in oncology at a very early age in high school, despite the fact that oncology was barely a specialty at that time and the lack of role models, particularly role models of color, and women in particular. She received a Bachelor of Science degree in Biochemistry with distinction from Tennessee State University and a medical degree from the Medical College of Virginia and Richmond.   In 1973, while still attending medical school, Edith joined the Air Force, receiving a commission through the Health Profession Scholarship Program, and eventually rose to the rank of Brigadier General. She completed a residency in internal medicine at Meharry Medical College in Nashville and a fellowship at Medical Oncology at Georgetown University. Her research interests are broad and involve new drug evaluation, development of new therapeutic regimens, combined modality therapy strategies, patient selection criteria, and supportive care for patients with gastrointestinal malignancies.  She is the leader of the GI oncology program at Jefferson Medical College, Director of the Center to Eliminate Cancer Disparities, and Enterprise Vice President for Cancer Disparities at Jefferson's Sidney Kimmel Cancer Center. She's held a number of leadership positions, including those in ASCO, and she's a former president of the National Medical Association. I could go on forever. So, Edith, welcome, and thanks for joining us on Oncology, Etc.  Dr. Edith Mitchell: And thank you so much for the invitation, Dave and Pat, it is a pleasure.  Dave Johnson: You grew up on a farm, as I recall, in Tennessee. Perhaps you could tell us a little about your early life.  Dr. Edith Mitchell: I grew up on a farm that my great grandfather's mother received about 1863 when the Emancipation Proclamation was made. I was the fifth child in my family. My parents were working, my older siblings were in school, so my great-grandparents were my babysitters, so I spent a lot of time with them. He was 89 at the time, became ill, and I overheard family members and neighbors say that they couldn't take him to the hospital because Blacks were not treated properly in the hospital, so they were going to take care of him at home. A physician made a house call. When he left, I told my great-grandfather, “Pa, when I grow up, I'll be a doctor just like Dr. Logan and I'll make sure you get good health care.”  So, at three years, I decided I would become a doctor and I would make sure that Blacks received good health care. My work in disparity started when I was three. So, after my sophomore year in high school, there was a National Science Foundation program in Memphis at LeMoyne-Owen College. So, I applied and was accepted. And part of the time in Memphis that year, we were given opportunities to go to St. Jude. So my time at St. Jude made the decision that I would become an oncologist. I became really fascinated by cancers and in pathology, use of the microscope, and how cancers were all different, how they varied from the normal tissue for areas such as the colon or the stomach or the pancreas. Dave Johnson: It's amazing that that early in your life you made that kind of decision.  Can I back up just one moment? I want to ask you briefly about the doctor that visited your great-grandfather, Dr. Logan.  Dr. Edith Mitchell: Dr. Logan was a family physician, African American, and he had a great interest in Blacks being healthy. In fact, when the polio vaccine was made public, Blacks could only go one day per week because you couldn't go the times when whites were there. Dr. Logan obtained the vaccine and he would line the children up at his office. He gave me my first polio vaccine. He was a very handsome man. And, you know, Dave, I found out later that the medical school that he attended in Memphis was one of the ones closed as a result of the 1910 Flexner Report. So he had to go to Meharry in Nashville and take other courses to maintain his license to practice medicine.  Pat Loehrer: Were you the first one to go into medicine? Tell me about that background and how your family influenced you personally.  Dr. Edith Mitchell: Neither of my parents finished 8th grade, but they were very smart. They pushed their seven children to do well. They provided educational materials in our home and encouraged us to work and to take advantage of opportunities. Dave Johnson: Let's move forward a little bit. I thought I knew a lot about you, Edith, but I didn't realize that you were a Brigadier General. What was the motivation for joining the service in the ‘70s when you were at med school? Was it scholarship funding, or was there just patriotic zeal or a little of both? Dr. Edith Mitchell: My main objective was, for financial reasons - a scholarship covering all expenses of medical school, plus a monthly stipend. When I was in medical school, one of my laboratory instructors told me about this new scholarship program, and I said, "Okay, I just want to graduate from medical school." So he says, "Well, I know people in the surgeon general's office. I'll have them send you the information." He did, and I looked at it and didn't remember David, that my husband filled out the application. After my neurosciences final exam, I came home, and he says, "Your commission came in the mail today." So I said, "Okay." He says, "Well, I can swear you in. We can't do it at home because you have to have a witness. You take a nap, and then we're going out to job control, which was where all the aircraft controlled, the control room." We went there. We've got a picture of the swearing-in, and we then went to the officers club. It was Friday, and there were lots of people in his group from the Air Force Academy, from Citadel, Virginia Tech, and others. And they were all talking. "Yeah, Edith got a mail-order commission.”  So I owed the Air Force two years, and I practiced at Andrews Air Force Base, which was the presidential squadron. You hear the president always leaving Andrews Air Force Base. So I think I was 29 maybe, but I was young, and here I was taking care of senators and other important people in government, and these are people I'd only seen on TV before. So I had a really good experience. I received many accolades, but also many letters from people for whom I cared for. And I was therefore invited to stay on in the Air Force, either go to Walter Reed or to San Antonio. I said, "No, I'm going to Georgetown." So one of the VIPs, if I mentioned his name, you would know, said and wrote a letter for me that the Air Force should give me whatever I wanted and whatever I needed to continue in the Air Force. So I received my Air Force pay while I was a fellow at Georgetown.  So I stayed on. I got promoted early and engaged in Air Force work. I loved it, and I did well in that atmosphere and stayed on. After my second child was born, I decided I could not continue active duty and take care of two kids. So I left the Air Force, went to the University of Missouri, and someone called me one day and said, "You know, I hear you are at the University of Missouri now. Would you consider joining the National Guard?" I went, “ Joining the National Guard? Why would the National Guard want an oncologist?” And the information was, the Air National Guard wants good doctors, and you've got a great record. They invited me to St. Louis to just see the National Guard squadron there. I filled out the application while I was there and in a few days was appointed to the National Guard.  So after being there for a few years, I was discussing with one of the higher-ranking people in the National Guard who was in Washington, but visiting St. Louis. He said to me, "You know, you've done great work." He had gone through my record, and he said, "And you know, you're one of the people being considered to be in a group for promotion. Promotion at that time meant that it was a higher rank." So he said, "There's one thing you don't have in your records, however, and other competitors in your group have." I said, "What's that?" “You haven't been to flight school.” I said, "Okay." He said, "And everybody who is going to be competing with you will have gone to flight school, and having a flight record will be an important part."  So I was in my 40s. My oldest child was 14. I went to flight school and I got my certification, and obviously, I got promoted. And I am the first woman doctor to become a General in the history of the Air Force. And it was really interesting. I'm a Brigadier General. I'm invited to give a talk someplace, and there were lots of people there. So the person introducing me said, "And she is the first African American woman to become a General in the history of the United States Air Force." So I get up to speak and I thank him for this introduction. And I said, "Yes, I was the first Black woman physician to become a General. I said, but, you know, my ancestry says that I'm 30% something white. So I guess I was the first white woman, too." There was a big roar. But I loved every opportunity, and I worked hard at every opportunity.  So when I was in the active duty Air Force, I was chief of the cancer center at Travis Air Force Base. So I made my application for research with the Northern California Oncology group, got, they said, one of the highest ratings of the applicants at that time. And I received a phone call from Air Force administration saying “Congratulations, but the Air Force cannot accept this funding from the National Cancer Institute.” There is a law saying you can't transfer money from one area of the government to the other, as they called it, a "gift," but it was a grant. So I call Phil Schein and I tell him about the situation. And he already knew that I had received a top report, and he knew that I had the grant before I knew. So he says, "Well, let's see what we can do.”  Now, remember, Vince DeVita was the NCI Chair at that time and Dr. Rosenberg. At every ASCO meeting Phil, Vince, and Dr. Rosenberg would get together and they would bring their fellows. And Bill said, “Let me see what I can do.'" So somebody at NCI made some things happen. And I got this call from Saul Rosenberg. "Edith, congratulations." So I said, "Well, thank you, but I didn't expect a phone call from you." And he says, "Well, there have been some changes. Your grant, the face sheet has been changed." I said, "Oh.”  Pat Loehrer: Your husband again. Dr. Edith Mitchell: I can't say who or what, but it had Stanford on it. So my grant went to Stanford. I'm sure they appreciated the kick you get. But Dr. Rosenberg said, "Your grant is now Stanford. We're setting up an account for you at Stanford, and the funding goes to Stanford.” So I had people working for me at the Air Force Cancer Center who were Stanford employees. Dave Johnson: Edith, there are still too few African American and particularly African American men in medicine. What's your perspective on that?  Dr. Edith Mitchell: I think that many people are not given opportunities, and I've been concerned about Blacks and other racial and ethnic minorities not entering medicine, and particularly regarding oncology. So fewer than 5% of all practicing physicians in this country identify as Black. Little more than 5% identify as Hispanic. And I've been trying to do something about that. So ECOG-ACRIN has been very good about allowing me, and I set up with others, but I was the lead, a program for individuals - they could either be medical students, residents, fellows, or early faculty - to attend ECOG-ACRIN. And as a result of that program, we identified 12 individuals for each of the two ECOG-ACRIN annual meetings. We bring people in, and that has been a success. There's one person I introduced when she was a resident, she then did a fellowship in oncology, and it is now in her first year as faculty. And we have students mainly from Tennessee State. I do maintain very close relationships with Tennessee State, and I have the first Tennessee State student who has just been admitted to medical school at Jefferson. So trying to work with them.  As a result of my work with the National Medical Association and the International Myeloma Foundation, we have a group of medical students that have been mentored for oncology. Whether they will become oncologists, I don't know, but they all 12 are doing well in medical school, and with some anticipation they might select oncology as their area of specialty. We set them up with an individual mentor, various oncologists around the country, and they have conducted research with their mentor.  So I'm doing things that I think will be helpful to individuals. And I think we're not giving Blacks enough opportunities. Even in entering medical school, the number of Blacks entering most majority medical schools is still very low. Somewhere nine or ten students per year, Blacks entering medical schools. And also there has been a study conducted by the ACGME, which is the Accreditation Council for Graduate Medical Education, looking at graduate studies in oncology. Do you know that most of the oncologists have been trained at a few medical schools? And there are, I think it was 109 programs did not have a single minority student in the fellowship program. And that's terrible. I think that all fellowship programs should have some racial or ethnic fellows in their programs. Dave Johnson: Yeah. One of the disturbing statistics that I've read from the AAMC is that the number of African American men applying to medical school in 2023 and 2022 is actually less than the number that applied in the ‘70s. It's puzzling to me why we've not been able to attract young men into the medical profession, and perhaps it's because there's a sense of not being wanted or encouraged into the profession. More African American women are applying, but even that number is small, at least in terms of the increase in what we've seen. Pat Loehrer: Edith. You're also the Associate Director of Diversity Affairs at the Sidney Kimmel Cancer Center. What does the recent Supreme Court decision against Harvard in terms of admissions policy, how are you viewing that now at Jefferson? Dr. Edith Mitchell: So I think that the Supreme Court decision certainly was disappointing, but it is what it is, and we've got to deal with it. That is the Supreme Court. So my suggestion and what I am telling students that they have to do, you do have the essay. So when I applied to medical school, I did not talk about Dr. Logan, my growing up on the farm, or my parents not finishing 8th grade. But if I were applying to medical school now, I would use all of that background to include in my essay. And the Supreme Court didn't say that you couldn't include that information in your essay. It said the schools could not use your racial background as a part of the equation, but your letter is still there, and therefore, I would include all of that in the essay, so that you do have an advantage. We've just got to be able to do what we've got to do, not put the university or the medical school at risk because of the Supreme Court decision. But there's nothing in that decision that says you can't include that information in your letter. Dave Johnson: I have one question. What career advice would you offer your younger self? If you could speak to your 30-year-old self based on your knowledge, experience, what career advice would you give yourself? Dr. Edith Mitchell: So the one thing that I did not do when I was about 30 years old and I'm not sure I even knew about it, I think I could have done more in health policy, and the one thing that I have not done is become a White House fellow. And that's usually early in your career plan. But I think my research would have suffered had I done that. And I still say I don't know that I made bad choices. Dave Johnson: No, you didn't make bad choices. Knowing you, you could have been a White House fellow and done everything else you did. Pat Loehrer: And your husband did not make a bad choice either. Dave Johnson: Evidently not. Pat Loehrer: Edith, thank you so much for joining us. You've had such an incredible life, and it's so rich, and we deeply appreciate your spending time with us.  I want to also thank all our listeners of Oncology, Etc, which is an ASCO Education Podcast. This is as you know, where we talk about oncology medicine and everything else. If you have an idea for a topic or guest you'd like to see on the show, please email us at education@asco.org. To stay up to date with the latest episodes and explore other educational content, visit education.asco.org. 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.  

In this latest episode of ASTCT Talks, Dr. Tania Jain engages in a conversation with Dr. Richard Jones, the BMT director and co-director of the Hematologic Malignancies Programs at Johns Hopkins University. He shares his journey in the field of oncology and transplantation, reflecting on the life events and experiences that led him to this path. He delves into the groundbreaking development of post-transplant cyclophosphamide (PTCy) and its significant impact on transplant procedures. Gain insights into the behind-the-scenes efforts and the role PTCy has played in expanding donor options and improving graft-versus-host disease prophylaxis. The episode also highlights Dr. Jones' dedication to mentoring and his commitment to family, emphasizing the importance of work-life balance in this profession. About Dr. Rick Jones Richard J. Jones, M.D. is Professor of Oncology, Medicine, and Pathobiology, Associate Director of the Sidney Kimmel Cancer Center for Faculty and Program Development, as well as Director of the Bone Marrow Transplantation (BMT) and co-Director of the Hematologic Malignancies Programs at Johns Hopkins University. His major area of research interest is normal and malignant stem cell biology, especially the translation of promising findings from the laboratory to the clinic to improve the treatment of malignant and non-malignant blood disorders. Examples of his research accomplishments have been the development of the stem cell marker Aldefluor and high-dose cyclophosphamide for auto- and alloimmunity. The latter has led to the ability to safely perform partially mismatched BMT, allowing now everyone in need access to BMT. He has authored over 300 articles and book chapters on hematopoiesis, hematologic malignancies, and transplantation biology. Dr. Jones is a past Stohlman Memorial Scholar of the Leukemia and Lymphoma Society. About Dr. Tania Jain, MBBS Dr. Jain, MBBS, (@TaniaJain11) is a physician scientist in the hematological malignancies and stem cell transplantation division with Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins. Her academic focus is cellular therapy and transplantation in the treatment of high-risk hematological malignancies especially myeloproliferative neoplasms. Her primary research focus is to develop strategies to improve outcomes and prevent relapse of hematological malignancies following allogeneic stem cell transplantation. She also serves as the Director of the Immune Effector Cell (IEC) Therapy at Johns Hopkins, where they are currently expanding their CAR T program to help patients with advanced hematological malignancies. Her academic interest in this space lies in developing novel IEC strategies and studying aspects of toxicity of CAR T cell therapy with an aim to improve long term outcomes in these patients.

Beyond Literacy offers free services that provide Philadelphia residents with basic literacy skills for adults and families, high school diploma test preparation, English language classes, and training for jobs in the energy sector. During the pandemic 30 percent of their adult learners were able to access home broadband and devices because of a program called PHL ConnecteED. That program is about to expire in July but there is help. To tell us more, I speak to Zaire Martin, Digital Navigation Specialist, Beyond Literacy.Website: www.beyondliteracy.orgSocial media: Facebook www.facebook.com/beyondliteracyphilly       Instagram www.instagram.com/beyondliteracyphilly It is critically important for Black Americans and other minorities to participate in clinical trials because they are underrepresented in research, and this can lead to disparities in healthcare. I speak to Natisha Muhammad—Clinical Research Project Manager of Sidney Kimmel Cancer Center's (SKCC) Bone Marrow Transplant (BMT) and Immune Effector Cellular Therapy (IECT) team and Dr. Usama Gergis—Director of Thomas Jefferson University's Bone Marrow Transplant and Immune Effector Cellular Therapy Program about barriers to access to excellent healthcare, efforts to engage women and communities of color in clinical trials and a look at innovations in treatments for blood cancers. Website: https://www.jeffersonhealth.org/clinical-specialties/stem-cell-transplant-cellular-therapy-programTwitter: Jefferson Health @TJUHospitalFacebook: Jefferson HealthInstagram: jeffersonhealthLinkedIn: Jefferson HealthYouTube: Jefferson Health

Drs. Allison Zibelli and Arielle Heeke discuss the NATALEE trial's novel approach to high-risk HR+ breast cancer, the potential of delaying CDK4/6 inhibitors in HR+, HER2-negative mBC to decrease toxicities and costs in the SONIA trial, and de-escalation strategies in HER2+ early-stage breast cancer. TRANSCRIPT Dr. Allison Zibelli: Hello. I'm Dr. Allison Zibelli, your guest host for the ASCO Daily News Podcast today. I'm an associate professor of medicine and a breast medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health in Philadelphia. My guest today is Dr. Arielle Heeke, a breast medical oncologist at the Levine Cancer Institute at Atrium Health in North Carolina.  Today, we'll be discussing practice-changing studies and other key advances in breast cancer that were featured at the 2023 ASCO Annual Meeting.   Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/DNpod.   Arielle, it's great to speak with you today.   Dr. Arielle Heeke: Thank you so much for having me.  Dr. Allison Zibelli: Let's start with LBA500. This was the NATALEE trial of ribociclib and endocrine therapy as adjuvant treatment in patients with hormone receptor-positive HER2-negative early breast cancer. What are your key takeaways from the study, and how do you think this changes our approach to high-risk ER-positive breast cancer?  Dr. Arielle Heeke: Yeah, this was definitely the study for which many of us were waiting to see the results. It was exciting to see the results come through so quickly. As you mentioned, the NATALEE trial was a phase 3 study that evaluated three years of adjuvant ribociclib at a dose of 400 milligrams, which is a little different than what we're used to in the metastatic space at 600 milligrams. But essentially, it randomized patients to receive this 400-milligram dose with their adjuvant aromatase inhibitor therapy versus just the standard of care adjuvant endocrine therapy in patients that are high risk with early-stage breast cancer.   What made NATALEE somewhat unique is they defined high risk a little bit more broadly than we've seen in previous studies, such as monarchE. So, what I mean by that is NATALEE enrolled patients with stage 2 and 3 early-stage breast cancer. And notably, they allowed for patients that were lymph node-negative but had some other high-risk features, such as a grade 3 tumor or a grade 2 tumor with high-risk genomics, such as oncotype or a high Ki-67. So, by broadening who was eligible, NATALEE captured more patients at risk for recurrence. Of course, we know that recurrence is not specific for patients with lymph node-positive disease. We can see recurrence even with stage 1, but certainly, we start to see more recurrence risk as patients drift into stage 2 and stage 3.   In the NATALEE study, the majority of these patients did receive prior chemotherapy, which I also think is interesting. We've kind of seen in the metastatic space that sometimes chemotherapy can augment patients' responsiveness to CDK4/6 inhibitors. But specifically in NATALEE, 88% of patients had received prior chemotherapy, and ultimately, about a third of the patients were lymph node-negative.   So, diving into some of the results with this first analysis that we saw at ASCO, with the median follow-up for invasive disease-free survival of just 27.7 months, they were able to show that the risk for invasive disease was reduced by 25.2% with the addition of ribociclib plus endocrine therapy compared to endocrine therapy alone. And this three-year invasive disease-free survival rate was 90.4% for the combination therapy compared to 87.1% for endocrine therapy alone, which is an absolute difference of 3.3%. Additionally, patients treated with ribociclib and endocrine therapy had a 26.1% reduced risk for distant disease-free survival compared with endocrine therapy alone, and this was a rate of 90.8% for ribociclib with endocrine therapy compared to 88.6% with endocrine therapy alone, which correlates to an absolute benefit of 2.2%.    They did show results for overall survival as well, but again, follow-up was just a median of 27.7 months. So, data was essentially immature to show any true overall survival benefit from this approach. And in fact, only 20% of patients had completed three years of ribociclib at this data cutoff. And as a reminder, again, NATALEE involved ribociclib for three years compared to two years, which we've seen with other studies in this space.   Also, what was encouraging from NATALEE were the readouts for toxicities. Neutropenia is definitely a concern with this class of medication, and they were able to show that rates of neutropenia were overall lower than what we've seen in the pooled data in the metastatic space. And also that problematic QTc prolongation for which we have to get EKGs baseline two weeks and four weeks. They also showed that the likelihood of having QTc prolongation on this therapy was significantly less at that 400-milligram dose compared to 600.   I think the key takeaway is yes, this drug is effective as adjuvant therapy, which is perhaps not surprising since we've seen such promising results in the metastatic space, but numerically not as striking as what we have at this point with adjuvant abemaciclib, but of course, this is a newer study. We hope to see that continued separation of the curves as we were fortunate enough to see with the abemaciclib data, but obviously we'll be looking for additional analyses from NATALEE.    And then how this will change practice, of course, we'll have to wait to see if the therapy is approved for use in the adjuvant setting for early-stage hormone receptor-positive breast cancer, but it certainly will be a nice option for patients that struggle with GI toxicity kind of at baseline. But also, if they were previously on abemaciclib and were not able to tolerate due to the GI toxicity, this would be an option for them. Also, as mentioned, it's a broader patient population, so we can consider this perhaps for a patient with lymph node-negative disease.   Although we will have to ask ourselves that just because someone meets eligibility for the NATALEE  study, and if the therapy is ultimately approved, is it appropriate to give it to all those patients? Or do we need to still kind of think of this in the setting of the highest-risk patient, not just any patient with stage 2 plus disease? There was a lot of talk at the meeting, certainly about biomarkers and potentially using ctDNA to try to find these predictors of benefit from CDK4/6 inhibitor therapy, but obviously, still a long way to go before we can use that type of technology in this space.  Dr. Allison Zibelli: Thank you. Staying on the topic of CDK4/6 inhibitors, everybody was excited about the SONIA trial, which was LBA1000, and this trial was asking if we can delay using CDK4/6 inhibitors for newly diagnosed ER-positive HER2-negative metastatic breast cancer as a way to decrease both toxicity and cost. Tell us about this study.  Dr. Arielle Heeke: The SONIA trial was such a cool study to see, and the presenter reported findings in such a thought-provoking way. Really great to see this sort of work being done because I think we all wonder deep down in our gut, if more is more, or if we do need to kind of be a little bit more thoughtful about how we introduce these therapies certainly from a patient perspective. Patients that participate at ASCO [meetings] have been saying for years how important it is to consider the toxicities in terms of side effects, but also, of course, financial toxicities. So, it was great to see the SONIA trial at center stage.   Essentially, as you mentioned, it was a study that randomized patients in the first-line setting with metastatic hormone receptor-positive breast cancer to receive either first-line CDK4/6 inhibitor therapy or second-line CDK4/6 inhibitor therapy. So basically, there was a mandated crossover, so patients that received the CDK4/6 inhibitor first-line did not receive a second line and vice versa. Patients that were randomized to receive their endocrine therapy as monotherapy first line went on to receive CDK4/6 inhibitor at second-line. And the second-line endocrine therapy was fulvestrant in both of those situations.    We kind of run into this problem with patients now where we have so many therapies available to us that we don't typically run out of treatment options, but rather we run up against treatment toxicity or ultimate failure of the human body to keep up with the demands of ongoing therapy. So, again, while it's maybe somewhat attractive to start treatments earlier using things first-line rather than second-line or longer, just kind of post-CDK4/6 inhibitor progression, you know using this CDK4/6 inhibitor again with a different endocrine therapy backbone is probably not offering a meaningful benefit to that many patients. So this type of study is so necessary to really try to help us frame who needs those therapies sooner and longer or perhaps is there a substantial portion of patients that we don't need to put them through that sort of toxicity.   So that's the SONIA trial. Some things to note about the patient population, these patients were a bit older than what we've seen in some of our metastatic CDK4/6 inhibitor trials. There was a median age of 64 and 87% were postmenopausal. Additionally, just 40% had received prior chemotherapy. And as is true for most of our studies, 91% have received palbociclib on study with just 8% receiving ribociclib. And the choice of the CDK4/6 inhibitor was per the treating provider, and at the time of the of study globally, palbociclib was the more commonly prescribed CDK4/6 inhibitor. But over the last year or so, data has certainly emerged favoring ribociclib in the metastatic setting.   On the SONIA trial, patients were monitored for a median of 37.3 months. And looking at the primary endpoint of the second progression-free survival, which is defined as the time for random assignment to the second objective disease progression or death, for those patients who received first-line CDK4/6 inhibition, had a PFS2 of 31 months compared to 26.8 months with second-line CDK4/6 inhibitor use. And this slight difference was non-statistically significant. So the conclusion was that time to second progression was not impacted by whether or not a patient received first-line CDK4/6  inhibition or second-line CDK4/6 inhibition. Additionally, there were no differences in overall survival between the 2 arms with a median overall survival of 45.9 months with first-line CDK4/6 inhibitor use versus 53.7 months in second-line CDK4/6 inhibitor use.  And that actually equates to significant differences in time on drug. The median duration of CDK4/6 inhibitor use with first-line therapy was 24.6 months compared to 8.1 months with second-line use. And by being on therapy for an additional 16.5 months if you use CDK4/6 inhibitor first-line, this, of course, leads to increased toxicity and certainly increased financial burden. And it was estimated that for each patient that receives this therapy first-line, there is an additional $200,000 spent on getting them the CDK4/6 inhibitor first-line, whereas the results from SONIA suggested that whether you use it first-line or second-line, the outcomes are essentially exactly the same.   And then specific for the SONIA trial, by conducting the study, they saved approximately €25 million on drug expenditure during the conduct of the trial. It's just amazing when you take it to that scale. And then lastly just to mention, they looked at quality of life assessments as well and there were no differences in the two arms whether they got first-line or second-line CDK4/6 inhibition.  Dr. Allison Zibelli: I thought this study was remarkable, and it got a long ovation when it was presented at the meeting. I'm certainly going to use this strategy and prioritize who needs upfront CDK4/6 inhibitor therapy.  I think that we have to think of not just drug toxicity for our patients, but financial toxicity. A lot of these drugs have very high copays and the number one cause of bankruptcy in the United States is medical costs. So that's something we really have to keep in mind. I also thought it was very interesting that the study was designed in cooperation with the patient advocacy group and patients themselves were very enthusiastic about this study and helped design it and helped recruit to it. So all in all, I thought this was a remarkable study.    So moving on, LBA1013 was the TORCHLIGHT study of toripalimab versus placebo in combination with nab-paclitaxel for patients with metastatic or recurrent triple-negative breast cancer. Many of us are not familiar with toripalimab. Can you tell us about the drug and how it was used in this study?  Dr. Arielle Heeke: Yes, toripalimab is essentially an immunotherapy agent. It's an IgG4K monoclonal antibody that targets PD-1. In this study, TORCHLIGHT, patients were randomized to receive toripalimab versus placebo in combination with nab-paclitaxel in newly metastatic triple-negative breast cancer. The patients on study were randomized two to one to receive drug or placebo. The drug is given on day 1 of a 3-week cycle at 240 milligrams and then patients of course also receive nab-paclitaxel on a day 1 and day 8 schedule of a 21-day cycle. They did look at outcomes on the study based on PD-L1 positivity status and they assessed for PD-L1 with an IHC assay JS311 antibody that ultimately generated a combined positive score. And PD-L1 positivity was defined as a CPS of greater than or equal to one based off of this assay. In the study population, about a third of patients were- patients' tumors were CPS negative, a third had a CPS of 1 to 10 and about a quarter had a CPS of greater than or equal to 10. And then approximately 7% of the tumors had an unknown status.   And then getting right into the results, we were provided results in the PD-L1 positive subgroup as well as the whole patient population. Looking at the primary endpoint of PFS, there were significant improvements seen in median PFS with the addition of toripalimab to nab-paclitaxel, again in the first line setting with a median PFS of 8.4 months with the addition of the immunotherapy agent versus 5.6 months with placebo. And this was statistically significant.  And then in the intent to treat population, there were some numeric improvements, in median, progression-free survival at 8.4 months with the addition of toripalimab versus 6.9 months with placebo.   We also got some results with overall survival that were quite intriguing, although this initial analysis was not designed to necessarily prove statistically significant differences in overall survival. But again, there were some promising trends. Looking first at the PD-L1 positive subgroup, the median overall survival was 32.8 months with the addition of toripalimab versus 19.5 months with placebo. Breaking it down a little bit further based on CPS values, for a CPS of 1 to 10, median overall survival was 32.8 months versus 19.5 months. And then for those very high CPS or greater than or equal to ten, median overall survival was not reached in this group versus 18.3 months with placebo. Also, looking in the intent-to-treat population, there were also improvements in overall survival with the addition of toripalimab with a median overall survival of 33.1 months with the addition of immunotherapy versus 23.5 months with nab-paclitaxel alone. So potentially, depending on next steps of this study, we would potentially have an option to add immunotherapy that is not biomarker specific, meaning we can potentially provide toripalimab to all patients regardless of their PD-L1 status.  Dr. Allison Zibelli: Very interesting new drug to look forward to. So, one of the major themes of this year's meeting was de-escalation strategies. For example, LBA506 reported the three-year invasive disease-free survival of the PHERGain trial, which looked at eliminating chemotherapy for HER2-positive patients getting neoadjuvant therapy. Tell us about the design of this study and how will it impact the care of these patients?   Dr. Arielle Heeke: The design was very complicated. I had to look at it a few times to really make sure I got my head around it. But I think once you do figure it out, you can see how there might be a path forward in clinical practice. Although I think for all of this work, it's maybe not ready yet for primetime, but certainly thought-provoking. But the PHERGain clinical trial, I feel like we've heard about this study for a little while and this concept of de-escalation really kind of started in the HER2-positive space. But this study was a randomized study of chemotherapy de-escalation and early HER2-positive breast cancer using PET/CT as a marker of response to therapies that don't involve chemotherapy.   Patients were eligible for the study if they had stage 1 to 3a HER2-positive breast cancer with no prior therapy for breast cancer, and ultimately 356 patients were enrolled in a 1 to 4 randomization scheme with the majority of patients ultimately enrolled into the experimental group, which is called Group B. So, to break down Group A and Group B, Group A essentially were patients that receive typical standard of care, which at this point is TCHP for six cycles, neoadjuvantly or prior to surgery. Once they complete those cycles they move into surgery and then Herceptin-PERJETA adjuvantly for additional twelve cycles.  I should also note that this study was conducted prior to results of the KATHERINE trial that showed benefit of switching to adjuvant T-DM1 if there's residual disease. So, patients in Group A as well as Group B did not receive T-DM1 at any point. So, again, Group A is kind of your standard of care. Group B was the “experimental arm.” And so, what they did in this arm to assess potential de-escalation strategies, patients first received Herceptin-PERJETA alone for two cycles with or without endocrine therapy, if they were also hormone receptor-positive. But after those two cycles, they underwent a PET/CT, and then if a response was garnered, they would continue with Herceptin-PERJETA and again plus or minus endocrine therapy to complete six cycles total before proceeding on with surgery. Then if they were fortunate enough to achieve complete response at the time of surgery, then they just continued with Herceptin-PERJETA maintenance, whereas if they did not achieve a complete response at the time of surgery, then they actually received TCHP 6 times adjuvantly. So, the chemotherapy was introduced after surgery.   And then going back to that PET/CT time point, if patients did not achieve a response at that check-in point, after 2 cycles of Herceptin-PERJETA, at that point they were transitioned to chemotherapy with TCHP, again, for six cycles. So, either they could kind of ride all the way through if they got that complete response at the time of surgery with Herceptin-PERJETA only, or if at surgery there was residual disease, they went on to receive TCHP after surgery, or if they did not have a response on that interim PET/CT after 2 cycles of HP then they would go on to receive TCHP neoadjuvantly.    So, looking at the results, they actually had 2 primary endpoints. The first primary endpoint was rates of a complete response at the time of surgery in patients that had a PET response. So, PET responses were actually seen in nearly 80% of all the patients treated with Herceptin-PERJETA without chemotherapy. And in those PET responders, a complete response rate at the time of surgery was seen in approximately 38% of patients. So, 37.9% of PET responders actually achieved a complete response when they went to surgery after receiving Herceptin-PERJETA alone, which is pretty amazing. I mean, we're used to seeing higher complete response rates with neoadjuvant therapy for HER2-positive disease, but again, this is a chemo-free regimen so that is encouraging for that 38% of patients that really didn't need chemotherapy.   And then the second primary endpoint, and this was what we saw basically for the first time with the 2023 ASCO Meeting, was results for the 3-year invasive disease-free survival in Group B or this experimental de-escalation group. And ultimately it was shown that the three-year invasive disease-free survival and the intent to treat group B population was 95.4%, which met its statistical endpoint, or, basically the null hypothesis was rejected. They just needed some sort of outcome that was not worse in terms of the 3-year invasive disease-free survival of 89%.   And then looking actually at the patients that kind of did the best. So, the patients that were PET responders and achieved a complete response at the time of surgery and therefore really only ever received Herceptin-PERJETA, their three-year invasive disease-free survival was 98.8%. So, really very good. Additional endpoints they looked at in Group A and Group B were favorable in terms of three-year invasive disease-free survival in Group A, and then three-year distant disease-free survival and three-year overall survival in both groups, all approximately 98%. So, very favorable.   So, ultimately, these findings reflect a potential role for a chemotherapy-free treatment approach for some patients with early-stage HER2-positive breast cancer. And this particular study, they used PET/CT to influence chemotherapy decision-making, which potentially identified 1 in 3 patients who can omit chemotherapy. With that, 80% of patients receiving the response with a PET/CT, and then of that, 80%, again, 38% actually having that complete response. And ongoing work is also being done to look at other mechanisms to assess for an opportunity to de-escalate with MRI imaging or HER2DX testing to again try to identify patients who can potentially defer chemotherapy in this setting. I did not see from the results what proportion of patients were hormone receptor-positive, which I think is also interesting when thinking about chemotherapy de-escalation, can you lean a little bit more heavily on endocrine therapy? Perhaps we'll get that data in the future.   Dr. Allison Zibelli: That's a very important point.  I would like to thank you, Dr. Heeke, for coming on the podcast today and sharing your valuable insights with us. We really appreciate it.  Dr. Arielle Heeke: Absolutely. It was a great meeting to dive into. It's always exciting to see what comes out of ASCO in the breast space. We're usually well represented there, and I hope that these studies will lead to further exploration.   Dr. Allison Zibelli: And thank you to our listeners for joining us today. You'll find links to all abstracts 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 a moment to rate, review, and subscribe wherever you get your podcasts.  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. 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.  Follow today's speakers:   Dr. Allison Zibelli   Dr. Arielle Heeke  @HeekeMD     Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:    Dr. Allison Zibelli:    None Disclosed   Dr. Arielle Heeke:   Honoraria: Merck  Consulting or Advisory Role: Jazz Pharmaceuticals, Caris Life Sciences, Amgen, Daiichi Sankyo/Astra Zeneca, Pfizer, AstraZeneca, Menarini, Genome Insight  Speakers' Bureau: Daiichi Sankyo/Astra Zeneca      

Dr. Allison Zibelli and Dr. Megan Kruse highlight the PALMIRA and LEONARDA-1 trials, a new standard of care in the treatment of hand-foot syndrome for patients receiving capecitabine, and other key breast cancer studies that will be featured at the 2023 ASCO Annual Meeting. TRANSCRIPT Dr. Allison Zibelli: Hello. I'm Dr. Allison Zibelli, your host for the ASCO Daily News Podcast. I'm an assistant professor of medicine and a breast medical oncologist at the Sidney Kimmel Cancer Center at Jefferson Health. My guest today is Dr. Megan Kruse, a breast medical oncologist at the Cleveland Clinic Taussig Cancer Institute. We'll be discussing key abstracts in breast cancer that will be featured at the 2023 ASCO Annual Meeting.   Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcript at asco.org/DNpod.   Megan, it's great to speak with you today.   Dr. Megan Kruse: Thank you for having me.  Dr. Allison Zibelli: Let's begin with Abstract 1001. This is the PALMIRA trial, a study of second-line endocrine therapy plus palbociclib in HER2-negative ER-positive patients. We all have patients who have progressed on a CDK4/6 inhibitor, and this trial investigated a possible treatment approach for these patients. What are your thoughts?  Dr. Megan Kruse: I think this is a really tough space to know what to do, so I'm glad that we're getting more data to help inform our treatment decisions here. And I think it's also really tough for patients to wrap their heads around letting a CDK4/6 inhibitor go when many of them have done so well with it in the first-line treatment setting. So, in this study, patients were randomized to either continue on with their CDK4/6 inhibitor in the second line, the palbociclib specifically, along with a different endocrine therapy versus just switching to a different endocrine therapy alone. And what I thought was interesting was that the progression-free survival for both arms of the study were actually pretty similar. But that if you look at six-month progression-free survival as a particular endpoint, there were more encouraging results in the patients that continued on with the maintenance palbociclib along with the alternate endocrine therapy compared to what they received in the first line. So, I think this leaves the door open for certain patients to maintain ongoing benefit from their first-line CDK4/6 inhibitor with a switch in the endocrine therapy in the second line.    The challenging thing is it's hard to know who these patients are. I didn't see anything yet in the abstract that would suggest a differential population where this approach would be more successful. But the authors do note that there are some additional biomarker analyses that are pending. So, I hope that we see some data there when the full abstract is presented to get a sense of who might be a good candidate for this approach within the hormone receptor-positive HER2-negative metastatic breast cancer population.  Dr. Allison Zibelli: Thank you for that, Megan. I am not alone in finding these patients very hard to treat once they progress on a CDK4/6 inhibitor because there really is no standard of care in this space. So, I'm hoping this will provide some additional guidance for this patient population.  Dr. Megan Kruse: Yeah, I agree. Absolutely. I think the patients in the second line are now very different biologically after they've received CDK4/6 inhibitor. So, knowing what to do in this space really challenges our historical standards of care and I think it's a big gap in knowledge.   Dr. Allison Zibelli: Next, let's talk about Abstract 1007. This was a study about fixed-dose capecitabine and metastatic breast cancer. We all know that the package insert dose for capecitabine is probably too high, and a lot of us have been tinkering with the dose and scheduling in the absence of good evidence for that approach. This study looked at the efficacy of a lower dose with a fixed schedule. How do you think this will influence clinical practice?   Dr. Megan Kruse: Yeah, I was excited to see this study. I think that has pretty immediate ramifications for what we do. And particularly with respect to the fixed-dose of capecitabine that was chosen, the authors ended up going with 1,500 milligrams twice a day, which honestly, in my practice is sort of where I end up with a lot of my patients. Even if I try to start higher based on their body weight and based on the package insert dosing, I find that I pretty much end up at 1,500 milligrams twice a day no matter what I do. So, I thought that this was a very realistic study and happy to have it as part of our collective breast cancer knowledge. The other thing that was interesting here, not only the dose that they used but also the schedule that seven days on, seven days off I think is something that we do have data and a precedent for, although it doesn't seem to be utilized from the beginning. I find myself sticking with the 14 days on and seven days off when I start patients on capecitabine for metastatic disease management.   What was great in this study was that in terms of efficacy for cancer control, both dosing and schedules, either the fixed-dose or the standard dose seemed equivalent. So, that provides a lot of reassurance, I think, for us as providers, and we can share that easily with patients. But what was notable was that the incidence of diarrhea and hand-foot syndrome, mucositis as well, were all much, much better with the fixed-dose and that more limited seven days on, seven days off schedule. To me, that's very meaningful because I think we run into a lot of treatment delays and a lot of unnecessary modifications with our patients that we start on the higher dose, that maybe will have better dose intensity over time if we started with a lower dose and a schedule that is more feasible for patients and has a better impact on their quality of life. So, I think this was a great abstract, and I'm excited to see what happens with the utilization of capecitabine. It'll be nice to see some real-world data potentially, once this is out there, of what practitioners are actually doing.    Dr. Allison Zibelli: Well, I know that in my case, I'm immediately calling the builders of our EMR to put this into our treatment pathways. I think that capecitabine is underused in the community because of the perception that it has so many side effects and that's a shame because it really has a lot of activity and it's convenient for patients. So, I'm hoping this will allow oncologists to use this drug more in the second-line setting.  Dr. Megan Kruse: Yeah, I agree. I think it's a terrific option and it's that really nice bridge from the targeted endocrine approaches that we use for patients in the first line, potentially second line, then as they transition into needing chemotherapy and becoming endocrine resistant, having an oral option is really a nice bridge there and I'd love to see patients be able to stick with it longer than potentially some do, just based strictly on toxicity. So, I love having this data out there.   Dr. Allison Zibelli: So moving on to Abstract 12005. This is a related abstract because it's addressing a common toxicity in patients that are on capecitabine, which is hand-foot syndrome. This abstract described a randomized, double-blind, placebo-controlled trial of topical diclofenac to prevent hand-foot syndrome. Could you tell us more about this? And would you consider this to be a new standard of care?  Dr. Megan Kruse: I would consider this to be a new standard of care. I think that this abstract is exciting, number one because focusing on symptom management is something that we need more data on. I think we think so much about anti-cancer efficacy of our drugs, which of course is our first priority, but those drugs only have their benefit if we can get patients to take them. So focusing on symptom management is key and it's something that we don't see a ton of abstracts on many times at our national meetings.    And the other thing that I really like about this particular abstract is that the topical diclofenac is something that's so readily accessible. I would say that a lot of my patients have this in their medicine cabinets already because we're thinking about things like joint pain and arthritis all the time. So it's something that I think, again, is immediately actionable and it's hard to know exactly what we would do with this given the last Abstract we talked about where hopefully we're running into less hand-foot syndrome. But I see them as being very complementary pieces of data because there's no reason why we couldn't use both pieces of data together and use a more fixed-dose approach to our capecitabine prescriptions, but also use the topical diclofenac as another way to decrease the incidence of hand-foot syndrome.   I don't know about you, but hand-foot syndrome is the thing that I hear the most about with capecitabine. We're always educating on diarrhea and mucositis and blood counts and fatigue, but by far and away the day-to-day toxicity that I encounter that we manage or have to take time to think about is hand-foot syndrome. So knowing that the use of the topical diclofenac decreases the incidence of hand-foot syndrome in general and particularly higher grade and more problematic, hand-foot syndrome, I think is a big step forward. Our patients are always looking for things to add to their arsenal for symptom management. So we already have a list of moisturizing lotions we talk to them about, and I see us adding this line about the topical diclofenac in there right away in June.   Dr. Allison Zibelli: I agree with you. I think that there is not enough attention paid to the side effects of our therapies and I thought this was a great abstract.    Next, let's talk about the LEONARDA Trial. Abstract 1017. This trial assessed lerociclib, a novel CDK4/6 inhibitor, in ER-positive HER2-negative metastatic breast cancer. Could you describe this trial and how do you think that this fits into the treatment landscape?  Dr. Megan Kruse: So this trial, the LEONARDA Trial, uses lerociclib in combination with fulvestrant for patients with essentially second-line treatment of HR-positive HER2-negative breast cancer, and is randomized against fulvestrant in combination with placebo. And what we saw here I think is a pretty typical trend that we see for our endocrine therapy CDK4/6 inhibitor studies where there was roughly a doubling of progression-free survival. So the progression-free survival was 11 months with the lerociclib and fulvestrant combination compared to the placebo fulvestrant combination at 5.5 months. The response rates were also higher in the CDK4/6 fulvestrant arm compared to the fulvestrant placebo arm at 26.9% versus 9.9%.   What's interesting about this particular novel CDK4/6 inhibitor is that it's continuous dosing and it's BID dosing from what the abstract describes. And I think then that leads to a natural comparison with our other continuous BID dosing, CDK4/6 inhibitor, which is abemaciclib. And so when I was evaluating this abstract, I think the efficacy results were pretty much what I was expecting for a CDK4/6 inhibitor with endocrine therapy. What drew my attention was more the toxicity information. And so when you look at that, you actually see a pretty high rate of both neutropenia and leukopenia for this novel CDK4/6 inhibitor. Those were at 90% all-grade neutropenia and 87% all-grade leukopenia. And I think that's higher than what we would expect in comparison to abemaciclib. So if you look at the results for the MONARCH-2 trial, we're seeing all-grade neutropenia being about 50% with abemaciclib.    So when I'm thinking about how does this new drug fit into the landscape, you would think about patients who maybe have a preference for continuous dosing rather than cycled dosing like some of our other CDK4/6 inhibitors. But in that perspective, you'd be looking for some other sort of benefit, and I think when it comes to cytopenias, this might not actually fill that mark. It does seem to have a lower incidence though of diarrhea, so that is definitely a benefit. Here, we saw that all-grade diarrhea with the lerociclib was just under 20%, and the rate of that with abemaciclib in the MONARCH-2 trial was actually 87%. So if I'm looking for a combination of lesser diarrhea, continuous dosing, this might actually have a space. But I think it's hard to know what to do with the CDK4/6 inhibitors now that we have so many options. The selection of particular agents and the sequencing of those agents is still really a challenge. So as more drugs get added to the space, it just gets a little bit murkier about what we would choose.  Dr. Allison Zibelli: I agree. I'm not sure how I would fit this into my current therapeutic plan, so we'll be looking for more data about this in the future.   Dr. Megan Kruse: Agree.   Dr. Allison Zibelli: Finally, Abstract 517 looks at treatment outcomes for patients with very small node-negative HER2-positive tumors in the SEER database. I thought this was very interesting because we've had very limited data in this patient population. I recently had two patients in my clinic with these T1a and T1b HER2-positive tumors, and up until now, we really haven't had much guidance. So what can we learn from this data?  Dr. Megan Kruse: I agree with you. Clinically, this is a big challenge, and I think it is one of the challenges that comes about with having such excellent treatment options where we don't want to leave anything on the table for patients with potentially curable disease. And there's that specter of how aggressive HER2-positive disease left untreated or appropriately untreated is in our minds and what that could mean for patients' lives. And so I think our tendency for these types of patients is to treat more aggressively sometimes than we would need to in the absence of data. And knowing that many of our trials in this space have reflected patients with larger tumors or lymph node positivity really makes it challenging. So I was really encouraged to see these results, and it's a large study. So this is a study of almost 13,000 patients with stage I HER2-positive breast cancer, specifically T1N0 HER2-positive breast cancer. And as you might expect, most of these patients, about three-quarters, were also hormone receptor-positive.   So the authors did a really nice job at breaking down the breast cancer-specific survival results at three, five, and seven years over this time frame for patients and then dividing it out into the hormone receptor-positive HER2-positive and hormone receptor-negative HER2-positive. So I think the key points to take away from this are that overall, the breast cancer-specific survival for these patients is excellent. And I think that that is probably what we have come to expect with data that we've seen from the APT study and its longer-term follow-up. What was interesting to me about this was that the use of chemotherapy over the study period from 2010 to 2019 actually increased over time, and I would suspect that APT had a lot to do with that. Coming out in 2015 and suggesting that it was possible to treat these patients with smaller tumors in a way that hopefully was meaningful without overdoing it. I wasn't really surprised to see that trend.   I think the key takeaway point here is that for patients with T1c disease, those really seem to be the ones where we see a differential benefit between the group of patients that received chemotherapy and those that did not. For the T1a and T1b patients it seemed like breast cancer-specific survival at the different endpoints was quite similar and with really, really high numbers, I mean, between 98 and 100% survival. When you get to those T1c patients, that's where you're starting to see the numbers slip a bit. And with survivals that are about 4-5% different for the arm that received chemotherapy versus those that did not, in favor, of course, of the chemotherapy. The trend was actually more statistically significant for the hormone receptor-positive HER2-positive patients, which was unexpected in my mind. That might be more of a statistical change than anything because the magnitude of difference actually was a little bit stronger for the hormone receptor-negative HER2-positive patients.   But I think in general, what this reinforces for me is that those smallest of the small HER2-positive tumors probably don't need chemotherapy. And that's what's reflected in my institutional guidelines, and I think I will continue to practice that way. That's really for the T1aN0 patients. For the T1bN0 patients, those are patients that right now I am recommending chemotherapy for. And these results made me wonder if it's really necessary because the five-year breast cancer-specific survival was nearly identical in this study. So I'd love to have some more conversations with folks about that at ASCO and really think about what this means for our national guidelines. No surprise, I think the T1cN0 patients will continue to get chemotherapy, and that is appropriate in my mind based on this information.  Dr. Allison Zibelli: It's so nice to have data on something that's been a data-free zone for so long. So I was really happy to see this abstract.    So thank you, Megan, for coming on this podcast today and sharing your insights with us. We really appreciate it.  Dr. Megan Kruse: Thank you for having me. It definitely energizes me as we approach the upcoming ASCO meeting.  Dr. Allison Zibelli: And thank you to our listeners for joining us today. You'll find links to all the abstracts discussed today in the transcripts for this episode. Finally, if you value the thoughts and insights that you hear on the ASCO Daily News Podcast, please take a minute to rate, review, and subscribe. It helps other people to find us, and you can do that wherever you get your podcasts.   Disclaimer:  The purpose of this podcast is to educate and inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experiences, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Follow today's speakers:  Dr. Allison Zibelli  Dr. Megan Kruse  @MeganKruseMD  Follow ASCO on social media:   @ASCO on Twitter  ASCO on Facebook  ASCO on LinkedIn  Disclosures:   Dr. Allison Zibelli:   None Disclosed  Dr. Megan Kruse:  Consulting or Advisory Role: Novartis Oncology, Puma Biotechnology, Immunomedics, Eisai, Seattle Genetics, Lilly 

We speak with Drs. Ana Maria Lopez and Eleanor Walker on Health equity, how it can cause gaps in cancer care, and how we can address it with integrative oncology. Dr. Lopez and Dr. Walker both co-chair the Health Equity, Inclusion and Belonging Task Force of the Society for Integrative Oncology. Dr. Ana Maria Lopez is Professor and Vice Chair of Medical Oncology Sidney Kimmel Medical College and Chief of Cancer Services at Sidney Kimmel Cancer Center at Jefferson Health, New Jersey. Dr. Lopez has previously been the President-Emeritus of the American College of Physicians, and the former Chair of the Health Equity Committee at ASCO. Dr. Eleanor Walker is the Director of Breast Services in Radiation Oncology at Henry Ford Cancer Institute. She has received multiple awards including the University of Notre Dame Distinguished Black Exemplar and 1998 Univ of Notre Dame Sorin Award. She was also featured in 2006 as part of the Who's Who in Black Detroit.

Racial disparities in care and outcomes have been well documented but the problems can be particularly acute in cases of rare, genetic diseases. One example of this is the rare blood cancer cutaneous T-cell lymphoma. African Americans are twice as likely as people of European or Asian descent to develop CTCL, are typically diagnosed with more advanced disease, and have a lower survival rate from the condition. Kyowa Kirin North America, which produces the CTCL treatment Poteligeo, is working to address racial disparities to improve the diagnosis, care, and outcomes of African American patients with CTCL. We spoke to Kyowa Kirin Vice President of Public Affairs Lauren Walrath and Co-Leader of the Immune Cell Regulation and Targeting Program at the Sidney Kimmel Cancer Center at Jefferson Health Pierluigi Porcu, about CTCL, the disparities in care and outcomes for African Americans with the condition, and what they are doing to address that.

Dr. Allison Zibelli, of the Sidney Kimmel Cancer Center – Jefferson Health, and Dr. Hope Rugo, of the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, discuss the practice-changing DESTINY-Breast04 trial as well as novel therapies in metastatic HR+/HER2- breast cancer from the TROPiCS-02 and MAINTAIN studies, all of which were featured at the 2022 ASCO Annual Meeting.   TRANSCRIPT Dr. Allison Zibelli: Hello. I'm Dr. Allison Zibelli, your host for the ASCO Daily News Podcast today. I'm a vice-chair and breast medical oncologist at the Sidney Kimmel Cancer Center, Jefferson Health in Philadelphia. My guest today is Dr. Hope Rugo, a professor of medicine and the director of Breast Oncology and Clinical Trials Education at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco. We'll be discussing key advances in breast cancer that were featured at the 2022 ASCO Annual Meeting. Our full disclosures are available in the show notes, and disclosures of all guests on the podcasts can be found on our transcripts at asco.org/podcasts. Hope, it's great to talk to you today. Dr. Hope Rugo: Nice to talk to you, too. Dr. Allison Zibelli: Let's begin with perhaps the most exciting abstract at ASCO this year, which was the DESTINY-Breast04 study, that's LBA3, a randomized phase 3 study of trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-low, unresectable and/or metastatic breast cancer. What are your thoughts about this study? Dr. Hope Rugo: Well, of course, this is a hugely practice-changing study as was noted in the second-to-last slide by the discussant [Dr.] Pat LoRusso. So, antibody-drug conjugates are really the next step in delivering chemotherapy to cancer cells. The antibody-drug conjugates allow targeted delivery of a toxin to the cancer cell. I think we didn't understand how important this was going to be. These second, sort of, verging on third-generation antibody-drug conjugates use an antibody approach and to then have a new generation of linkers, which allow the drug to be released locally, but to then have drugs which pack a big bang for the buck. So, the way antibody-drug conjugates are constructed, you need to have a drug that actually can't be given as a naked drug because it's too toxic because you're giving just very small amounts of this drug that are delivered directly to the cancer cell. And the other really critical part of this is that the drug-to-antibody ratio of at least the successful and new antibody-drug conjugates (ADC) is quite high in the 7.5 to 8 toxins per antibody. Now, what that's resulted in is really interesting, is that there's a bystander effect. So, the toxin itself can leak out of the cancer cell that it's targeted and kill neighboring cells, but also because of the construct of these antibody-drug conjugates, what's likely happening is even if the cancer cell's a very low expression of the target, really low, you're able to actually get that ADC into the cancer cell to kill the cancer cell. So that may be a big part of the so-called bystander effect. So trastuzumab deruxtecan is biosimilar trastuzumab linked to a topoisomerase inhibitor deruxtecan, and what happened here was that of course, we saw remarkable data in HER2+ disease, unbelievable p-values in DESTINY-Breast03 compared to T-DM1, a first-generation ADC. But in DESTINY-Breast04, we targeted a population of patients largely with hormone receptor-positive disease who had a little expression of HER2, 1 plus or 2 plus by immunohistochemistry and no gene amplification. And this trial, which randomly assigned patients 2:1 and included just 58 patients with triple-negative disease. So in this trial, 480 had hormone receptor-positive breast cancer, a median of 1 line of prior chemotherapy. They were only allowed up to 2. They were refractory to endocrine therapy, a median of 3 lines of endocrine therapy. In the overall patients and in the hormone receptor-positive patients, there was actually a doubling in progression-free survival (PFS). It started very early, and it continued throughout, and at every landmark analysis, T-DXd was better than the treatment of physician choice that patients were randomly assigned to. It's also important when you're thinking about trials like this to think about what the treatment of physician choice was, and it was all chemotherapy regimens we would use. Paclitaxel, nab-paclitaxel, capecitabine, eribulin, or gemcitabine. And, so, I think that that doesn't bring up any questions. When they looked at the hormone receptor-positive group, they saw, if anything, even a bigger benefit overall. Now, the other endpoint of this trial was overall survival, and at this first analysis, they saw an improvement in overall survival that was quite dramatic. The absolute difference was 6.4 months, which is pretty amazing for an overall survival difference. And then they looked at this exploratory endpoint at the 58 patients who were valuable at triple-negative breast cancer, and then that group of patients, also saw an improvement in PFS of 5.6 months, an improvement in overall survival of 9.9 months, very small group, but amazing data. The forest plots are exactly what you want to see, all the dots line up to the left of 1, and overall responses improved. One of the concerns with this drug has been toxicity. The toxicity showed no new toxicity signals, which is really important. Nausea is the biggest issue that we deal with. It's mostly grade 1 and 2, but still something that's important to manage. A little bit of hair loss, not much in the way of bone marrow suppression, which is interesting. Interstitial lung disease (ILD) or pneumonitis continues to be an important issue to follow. 12% of patients had ILD of any grade. Most of it was grade 1 and 2, but 3 patients died, representing 0.8%. So, this really highlights the importance of monitoring and managing pneumonitis. Regardless of that, few patients had a reduced ejection fraction, but again, very, in general, low grade. This is really a new standard of care, and the standing ovation was really due to the fact that all we do is dedicate ourselves to trying to help patients live longer and better with their cancers, and in this trial, we have a huge win that has no qualifications. We can help patients not only control their disease longer but live longer with T-Dxd compared to standard chemotherapy. Dr. Allison Zibelli: So, Hope, I know as a practicing medical oncologist, I find that our metastatic triple-negative patients are often the biggest therapeutic challenges for us. Will they be doing larger studies with these patients that are HER2-low? Dr. Hope Rugo: It's a really good point. About 65% of patients with hormone receptor-positive disease or so-called HER2-low, centrally confirmed in the study. So, a fair number of people, about a quarter, did not have HER2-low disease when they were tested centrally. In the triple-negative population, who really are ER, PR, HER2- by standard definitions, about a third of the patients might have HER2-low disease. So, there's a lot of interest in further exploring that and looking at the patients who have ultra-HER2-low disease, so between and 1 plus a little bit of expression. That's been studied in the hormone receptor-positive population in DESTINY-Breast06. But there's a lot of interesting further defining that triple-negative population, so to speak, they're going to be triple-negative plus now and understanding what the benefit is in that population. So definitely will be looked at more now moving forward. Dr. Allison Zibelli: Thank you. So, let's move on to Abstract 1002. And the results from the phase 1, 2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate, and patients with HER3 expressing metastatic breast cancer. What are your thoughts about this study? Dr. Hope Rugo: That's a really interesting, another one of these second- to third-generation antibody-drug conjugates. It's just the antibody, instead of being the usual, sort of, HER2 or TROP2 that we're used to thinking about is directed to HER3, 1 of the HER family of proteins. This is interesting. There's actually been a lot of work trying to target HER3 with naked antibodies with disappointing results, although I have to say most of the studies really didn't push it too far. So, with this antibody drug construct, deruxtecan, which is the same as in T-DXd and another TROP2 ADC Dato-DXd is used. So, I will say they do need to change the toxin in the next generation of ADCs. But they looked at, at first did a dose-finding study which has previously been presented, and then a dose expansion in both hormone receptor-positive HER2-negative disease and triple-negative disease. All the triple-negative patients had HER3 high disease by immunohistochemistry, and the hormone-receptor-positive patients were enrolled in 2 cohorts, HER3 high and HER3 low. And the median number of prior treatment regimens that patients had received in the hormone-receptor-positive group was 6 and 2 for the triple-negative group, but there was a huge range, up to 13 lines of treatment. They only had 14 patients with HER2+ disease. So, it's a little bit hard to know what to do with that patient group, but they were heavily pretreated 5.5 prior lines of therapy. The confirmed overall response rate in the 113 patients with combined HER3 high and low was 30%, very impressive, heavily pretreated patients. For triple-negative disease all HER3 high, it was 23%. Again, very nice. And there were 14 patients with HER2+ disease that also were HER3 high. It was about 43%. So those are nice responses, but we always want to know how durable is that. The duration of response ranged from 6 to over 8 months in those 3 different groups. So, these were quite durable. It wasn't any 2- to 3-month duration of response. So very impressive. And then when they looked to see, did it matter whether you had HER3 expression that was high or low in the hormone-receptor positive group, they actually did see responses in the HER3-low group, some very good responses. Overall, there were less patients in that group, but it does suggest that maybe you would still see responses in the HER3-low group, very impressive. And then 1 really interesting correlative study they did was they looked to see what happened to the HER3 expression on the tumor cell over time, and it went down. So, you treated the HER3 expression in most of the patients just dropped off completely, which is really interesting. It didn't have any association with clinical activity, but it's sort of an interesting correlative endpoint. This is a drug that overall was pretty well tolerated. They saw a similar toxicity to T-DXd with a lot of nauseous, a little bit of alopecia, a little bit more bone marrow suppression than we're used to seeing with T-DXd. So, neutropenia was seen in about 10% of patients at the lower dose and about a quarter of the patients at the higher dose. Overall, pretty well tolerated. Now, interstitial lung disease is a toxicity with this construct, and they saw ILD of 7% but most cases were grade 1 and 2. The other interesting toxicity that's unique to this agent is thrombocytopenia. So, they saw a grade 3 or greater rate of thrombocytopenia of 27% in the lower dose group, and in the larger group that received the higher dose, 39% of grade 3 or greater thrombocytopenia, so platelets less than 100,000. Turns out that when you stop the drug, the platelets do come back, so that's a good thing. Sometimes we saw long-term thrombocytopenia with T-DM1. They didn't see bad toxicity like bleeding, but it is something that needs to be managed with this drug because we're not great at managing thrombocytopenia. In any case, it has fast-track designation for another solid tumor, not breast cancer, and we'll have to see where this fits into our dizzying array of very effective ADCs now. Dr. Allison Zibelli: The practicing medical oncologist is not used to testing for HER3 in our patients with breast cancer. How common is it? Dr. Hope Rugo: HER3 expression is quite common in hormone receptor-positive disease, a little less common in triple-negative breast cancer. So, I think that we would see expression if we were going to be treating patients with this particular approach. Dr. Allison Zibelli: All right. Let's move on to Abstract 507, which reported long-term outcomes of adjuvant denosumab in breast cancer, specifically fracture reduction and survival results from 3,425 patients in a randomized double-blind, placebo-controlled ABCSG-18 trial. What are your thoughts about this study? Dr. Hope Rugo: Well, this trial, this is an update of a study that previously has been presented and published, most recent publication was in Lancet Oncology in 2019, and these patients were randomly assigned to receive denosumab at 60 milligrams, important to note the dose, subcutaneously every 6 months versus placebo every 6 months, and they did get placebo subcutaneous injections. And this treatment continued through their endocrine therapy. They showed a dramatic reduction in fracture rate, and that has been maintained over time. We were really surprised enough to suggest that maybe Austrian people didn't go into the sun, so they got more Vitamin D deficiency, hard to know, but the hazard ratio is 0.5. It's unbelievable the number of fractures, 92 for denosumab but 176 for placebo, a P value of less than .0001. So, this is a real endpoint, treating patients who are receiving endocrine therapy that, in this case, non-steroidal aromatase inhibitor therapy that can increase bone loss, have a reduced fracture rate when they received denosumab. So that is the big take-home message, and a medium follow-up of 8 years. But the secondary endpoints included disease-free survival. They had about 20% disease-free survival events and 8% deaths, and what they saw was really interesting. So, the caveat is that 16% of patients were unblinded at the first analysis and half of them got denosumab, so it messed up their results a little bit, but the disease-free survival was significantly better in patients who received denosumab, and the hazard ratio of 0.83 and the hazard ratio does not cross 1. So that's very interesting, and even overall survival, they looked at 2 other endpoints, bone metastasis-free survival, and overall survival. They also trend towards an improvement with a hazard ratio of 0.8 for both of them. And they didn't actually see toxicity. So, patients' brittle bone fractures and osteonecrosis of the jaw (ONJ) are all concerning, but they really just did not see any risks in this patient population. I think there was 1 patient that had what they thought was a brittle bone fracture. Obviously, they watched the mouth very carefully as well. Really dramatic, and I think it's kind of disappointing that we never had any registration approach in this, and also not well-understood why the D-CARE study did not show a benefit, but I think D-CARE was designed differently. This is a better design to focus on our patients and the specific issues, and I think it's intriguing and should be considered as part of our treatment regimen for patients who are at risk for bone loss and have early-stage breast cancer on an aromatase inhibitor. Dr. Allison Zibelli: I've been using DEXA scans and offering denosumab to my patients on AIs that have osteopenia or osteoporosis. Should we be considering it in women with normal bone mass? Dr. Hope Rugo: I think not yet. Unfortunately, this trial was not immediately powered for cancer outcome, although the data are very encouraging. We don't know what the relationship is to bone loss, and providing an environment that's friendlier for cancer cells. So, do you have to have bone loss in order to have the risk that you're reducing with these agents? Certainly, that's what we've seen with zoledronate. So, I think that we don't have sufficient data to use this simply to treat cancer, but I do think that we should be considering this as an agent to give patients who have bone loss, either when you're starting an aromatase inhibitor or during the course of therapy. I think it's well tolerated, and a subcutaneous injection is not difficult. One of the questions that's come up for people is do you get bone loss that increases your risk of fracture after you stop therapy. But clearly from these updated data, these patients were off therapy. They did not have an increase of fractures and the patients treated with denosumab fared much better, I mean the hazard ratio of 0.5. Dr. Allison Zibelli: Let's move on to TROPiCS-02. That's LBA1001. This is a randomized phase 3 study of sacituzumab govitecan versus treatment of physician's choice in patients with hormone receptor-positive, HER2-negative advanced breast cancer. How do you think this study will impact practice? Dr. Hope Rugo: That's a great question. I presented this data, and I think I presented it on a Saturday, and on Sunday we saw the plenary talk of DESTINY-Breast04. These patients enrolled in TROPiCs-02 had a median number of lines of prior chemo 3 with a range of up to 8 actually, compared to a median number of lines as 1 in the DESTINY-Breast04 population. We included all hormone receptor-positive HER2 negative-advanced breast cancer, not centrally confirmed. They included just the HER2 low subset that was centrally confirmed. Everybody in our study had received prior CDK4/6 inhibitors compared to about 70% in DB04. And then 95% of patients in this trial had visceral mets. So, we did really treat a patient population who had very advanced high risk hormone receptor-positive breast cancer. As you know, we saw an improvement and progression-free survival with a hazard ratio of 0.66 meeting the endpoint. We needed a hazard ratio of 0.7, highly statistically significant P value .0003, but the median difference in PFS was only 1.5 months, and overall survival data is not yet mature. So that's brought up the question about how this drug should be used because there was a big fall off in the first 2 months where patients had rapid disease progression with heavily pretreated chemotherapy-resistant disease. We did landmark analyses and there were big separations in PFS at 6, 9, and 12 months, and 12 months, it was 21% patients free of progression and death at 1 year versus 7% for the TPC arm. So, it was a tripling of patients who were free of progression at one year. I think that's clinically relevant. This drug is associated with more neutropenia. That's the primary issue to manage, and probably half of the patients need growth factors at some point. When we looked at other endpoints response to ratio response, etc., we're better with Sacituzumab. So where does this all fit into our treatment paradigm. I think there's the HER2-low patients who will now receive T-DXd up in the, I hope, second line and not in lieu of endocrine therapy, when they're ready for chemo. But there are patients who don't have HER2-low disease and then there are patients who are going to be in the later line setting. So, I do think it still has a place in the treatment department, receptor-positive metastatic breast cancer. The results show that it was better than chemotherapy, physician choice based on our national and international guidelines, and that's better for our patients to have that option. Overall survival data obviously is looked for with great interest and that will help us put this into the right paradigm. And then I also hope that real world data will help us understand how sequential treatment with these different ADCs will benefit our patients. Dr. Allison Zibelli: This is really exciting. Do you think that we're maybe coming toward the end of conventional chemotherapy, especially for women with HER2-positive disease? Dr. Hope Rugo: I wonder if we are. I think we were interested in T-DM1 for HER2-positive disease early on. We've seen some really nice pathologic complete response data as well as adjuvant data in the attempt trial in patients who had stage I disease. Now that we have these second-, third-generation ADCs, T-DXd, I think this could potentially completely replace our chemotherapy. We still have to deal with alopecia. And I will point out ADCs are still chemotherapy. They're just a much more efficient and effective way of delivering treatment, and we need to be very careful to manage the toxicity. Dr. Allison Zibelli: Next, we're going to talk about the main pain trial that's LBA1004, which is a randomized phase 2 trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or hormone receptor-positive HER2-negative metastatic breast cancer, in other words CDK4/6 after CDK4/6. What are your takeaways here? Dr. Hope Rugo: First, just amazing that an investigator-initiated trial could do this well and be placebo-controlled. So, kudos to the principal investigator (PI) [Dr.] Kevin Kalinsky. This trial is a small phase 2 trial. A reasonable number, 119 patients were randomly assigned and evaluable patients could have received up to 1 line of prior chemotherapy for metastatic disease. If you had received prior exemestane, you received fulvestrant, if you received prior fulvestrant, you received exemestane, and actually if you looked at the number of patients who had received fulvestrant, it was 99 versus only 20 with exemestane. So important to keep in mind. If you looked at the overall population where the primary endpoint was progression-free survival, the hazard ratio is 0.57, just median PFS of 2.8 months in patients receiving endocrine therapy and placebo and 5.3 months for patients receiving endocrine therapy and ribociclib. So was this ribociclib after ribociclib or ribociclib after something else. 86% of patients had received palbociclib as their prior CDK4/6 inhibitor, and only about 10% to 14% had received prior ribociclib. So, there's a predominance of palbociclib followed by ribociclib. The other thing that's important to keep in mind is how sick this patient population was. Very few had received prior chemotherapy in the less than 10% range, visceral metastases in about 60%. So that's helpful. Only 19% or so had received 2 or more endocrine therapies from metastases. So, most people did this as their second line treatment. The PFS, when you looked at fulvestrant or exemestane, looked like the benefit was relatively similar, but you know you got 20 patients in the exemestane arm. The hazard ratios, looking at the subgroup analyses, all looked pretty similar, and the overall response and clinical benefit rate were better with continuing the cyclin dependent kinases (CDK) inhibitor. There was interesting sub-analysis looking at mutations and how that affected things. And they looked at patients who had ESR1 mutations or had wild-type ESR1. 42% had ESR1 mutations at study entry, very similar to what we've seen. In that group of patients, remember it's only 33 where they had this analysis, they saw a lot of other mutations. So p53, PIK3CA, FGFR, CCND1—those patients did not benefit. Only 33 patients. No benefit at all, very short PFS, about 3 months. The patients who had ESR1 wild type seemed to benefit a lot, 45 patients going from about 3 months to a little over 8 months. So, this is all hypothesis-generating data. I wouldn't run out and use this as your standard of care now because it is small data. But when the patient doesn't have other good options, I certainly would consider switching the CDK and going on, add that to the next line endocrine therapy. It's important to switch the endocrine therapy. I think we really need to look at the ongoing phase 3 trials to give us better evidence basis and understand the impact of mutations and prior therapy on who might benefit from continued CDK inhibitors after progression on a CDK inhibitor. Dr. Allison Zibelli: I think this is a really exciting trial. We all have a lot of patients on palbociclib and letrozole who've been on for 4, 5 years, and would like to continue with this kind of treatment because the side effects are really manageable. So, I look forward to seeing what's coming in the future with the phase 3 trials. So, let's talk about Abstract 1015, which I thought is a great idea. It looks at the quality of life with ribociclib plus aromatase inhibitor versus abemaciclib plus AI as first-line treatment of hormone receptor-positive, HER2-negative advanced breast cancer, assessed via matching adjusted indirect comparison. Could you tell us what matching adjusted indirect comparison is and why you chose this for the study? Dr. Hope Rugo: It's an interesting question. How do you compare across trials? So, matching this kind of make analysis, we'll call it a make analysis for the purposes of this discussion, allows you to match patients and weight based on their characteristics that might affect patient reported outcomes. And that actually is a way of trying to do a fair cross-trial comparison. So basically, take the study population, you match the inclusion and exclusion criteria, and then you weigh the different criteria so that you can try and make a better association. It's the best way we know of comparing across trials. You know, a lot of people ask why we didn't have PALOMA-2 in here, and that's because they used a different patient reported outcome tool. So, you have to use the same patient reported outcome tool in order to compare. So that's why we did this analysis, and it sort of came on the heels of a survey that Fatima Cardoso presented at San Antonio in 2021, where patients identified diarrhea as a symptom they really didn't like more than everything else. And you can imagine, I think we all have that experience in practice, the unexpected nature of diarrhea and the fact that it does limit your activities and, therefore, quality of life are important. In this analysis, interestingly but not surprisingly, ribociclib favored abemaciclib in diarrhea, and there can be associated appetite loss, so ribociclib also favored abemaciclib for appetite loss. And I thought the last one was interesting—fatigue—because I wouldn't have assumed that fatigue would be different. And maybe it's associated with diarrhea. They have these funny arm symptoms that were better. We don't really know why that was, and it's hard to assess again. We're really not clear based on the differences between the drugs. So, there are limitations to the analysis, but I think that it helps us really in individual patients try and match patients' underlying symptoms with the best treatment to offer them the best quality of life as they're being treated in the metastatic setting. Dr. Allison Zibelli: I thought this study was great because it really centered the experience of the patient and the wishes of the patient. You don't see that designed into many clinical trials, the way this was. So, I thought that was a great feature of this study. Dr. Hope Rugo: I will say that all of the 3 studies that looked at CDK inhibitors, all those 3 studies included patient-reported outcomes. That's an important new approach that is really being focused on. Dr. Allison Zibelli: Do you consider the CDK4/6 inhibitors equivalent in efficacy, and could you substitute them to try to get the side effect profile that you want? Dr. Hope Rugo: Well, I think that we saw in the early stage setting that there are differences. Now, across the different trials, there are big differences in patient populations and inclusions as we saw in the PALOMA-2 results that were presented at ASCO [Annual Meeting], whether the patients had prior chemotherapy like in PALOMA-3, whether they had a short disease-free interval, the higher risk patients in PALOMA-2. The PALOMA trials were more broadly inclusive than the other 2 studies, the MONALEESA and MONARCH series of trials. So, we do have to be a little bit careful about comparing apples to oranges, but we have the early-stage results of MONARCH E showing a clinically important difference in outcome whereas the PALLAS and Penelope-B trials didn't. So that sort of puts us into a little bit of a question period. Are these all patient populations or are there differences between the agents? The PFS and the metastatic setting, all the hazard ratios line up. So, in truth, although I know the activity against cyclin-independent kinases are different between agents, we don't still really understand the clinical differences in efficacy, but I think we all are practicing using evidence-based medicine. I wouldn't, for example, substitute a different CDK4/6 inhibitor for abemaciclib in the treatment of early-stage breast cancer. We have to just learn how to manage the diarrhea and use prophylaxis and dose reduce early to manage this and make it tolerable for our patients. And in the metastatic setting, I think we need to follow evidence-based guidelines and use the best data available to decide on the right treatment approach and sequencing for our patients. Dr. Allison Zibelli: Thank you, Hope, for coming on the podcast today. This was a really interesting review of one of the most exciting ASCO [Annual Meetings] I've been to. And thanks for sharing your valuable insights with us and helping us make sense of all this really new exciting data. We really appreciate it. Dr. Hope Rugo: Thank you. And thank you so much for inviting me. Dr. Allison Zibelli: And thank you to our listeners for joining us today. You will find the links to all the abstracts 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 a moment to rate, review, and subscribe wherever you get your podcasts. That really helps other listeners find us. Thank you.   Disclosures: Dr. Allison Zibelli: None disclosed. Dr. Hope Rugo: Honoraria: Puma Biotechnology, Mylan, Samsung Bioepis, Chugai Pharma, Blueprint Medicines Consulting or Advisory Role: Napo Pharmaceuticals Research Funding (Inst.): OBI Pharma, Pfizer, Novartis, Lilly, Genentech, Merck, Odonate Therapeutics, Daiichi Sankyo, Sermonix Pharmaceuticals, AstraZeneca, Gilead Sciences, Ayala Pharmaceuticals, Astellas Pharma, Seattle Genetics, Macrogenics, Boehringer Ingelheim, Polyphor 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. 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.

Dr. Brooke Worster and Dr. Nathan Handley of Sidney Kimmel Cancer Center – Jefferson Health shine a spotlight on cannabis use in palliative oncology.  They discuss guidance on dosing, legal concerns, and resources for oncologists with host Dr. John Sweetenham of the UT Southwestern Simmons Cancer Center. Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham, Associate Director of Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and host of the ASCO Daily News podcast. Recent reports in oncology journals suggest that 20% to 40% of all patients with cancer use cannabis in some form during or after treatment to manage symptoms. However, a national survey of medical oncologists in 2018 found that 70% of oncologists did not feel equipped to make clinical recommendations regarding cannabis and only 46% recommended it clinically. Joining me to discuss cannabis use in palliative oncology are Dr. Brooke Worster, an associate professor and the director of supportive medicine at the Sidney Kimmel Cancer Center at Jefferson Health. And Dr. Nathan Handley, a medical oncologist and an assistant professor who is also at the Sidney Kimmel Cancer Center. Our full disclosures are available on our show notes and disclosures of all guests on the podcasts can be found on our transcripts and at asco.org/podcasts. Dr. Worster and Dr. Handley, thanks for coming onto the podcast today. Dr. Brooke Worster: Thanks for having us. Dr. Nathan Handley: Thank you. Dr. John Sweetenham: Dr. Worster, can you tell us how cannabis and cannabinoid-based medicines are used in palliative oncology and how prevalent this is? In addition, could you say a little about the use of cannabis in patients with cancer in the United States and how it compares with other countries? Dr. Brooke Worster: Yeah, absolutely. I think we are realizing more and more that cannabis or cannabinoid-based medications are used much more often than we as clinicians were aware. We just weren't asking our patients enough. And so, you mentioned other surveys about the kind of nationally sample representative of patients with cancer, we actually just also completed one that was a National Institutes of Health (NIH)-funded study, looking at cancer centers across the country and found similar rates that patients with cancer under the age of 65, at some point during treatment or survivorship, about 50% of them had tried cannabis. Interestingly, the largest growing segment of patients with cancer starting to use and inquire about cannabis are our [age] 65 and older patients. So, a quarter of them now report using it. And we actually found that 45% of patients over the age of 65 were interested but didn't feel comfortable having the conversation. Our country is kind of middle of the road in terms of what's accessible and what we use. Certainly, countries like Canada and some places in Europe, as well as Australia have a much more advanced marketplace as well as legislation and access to cannabis. And so, it's used more prevalently across kinds of the oncology spectrum, but there are still a lot of countries across the world where cannabis remains completely illegal. So, the United States is sort of in the middle. Dr. John Sweetenham: Thanks. You and Dr. Handley recently co-authored an article in the ASCO Daily News along with other colleagues. And in that, you write the patients most often want guidance about the formulation and dosing, which as I read your article seems to be somewhat elusive still, given the diversity and composition of the plant-based strains. You point out that understanding the onset of action and duration of effects are important first steps. Could you say a little bit more about this? Dr. Brooke Worster: Yeah, absolutely. I think when someone is trying this for the first time, or for the first time in years, understanding how and when they're going to feel the impact or the effects of primarily tetrahydrocannabinol (THC) but also cannabidiol (CBD) and other minor cannabinoids is important for them to be patient. We see that people that ingest either sublingual absorption or oral ingestion of products, don't recognize that it can take up to 60 to 75 minutes, even if you have other food in your stomach to really feel the effect. And then will kind of overdose in some ways or sort of re-dose and get more of an effect of the THC than they were looking for. Versus if someone is inhaling something, you're really going to feel that quite rapidly, right? Five minutes in terms of onset of action. The duration of effect for that is much less. You're talking 2 to 3 hours maximum for an inhalation form, versus 5 to 7 hours for something that's sublingual, or orally ingested. Dr. John Sweetenham: Thanks! Dr. Handley, we've read in your article and in others, that cannabis as a palliative treatment for patients is well-tolerated, safe, and an effective option to help them cope with malignancy-related symptoms. Can you comment a little on whether or not there is a downside to cannabis and cannabinoid use and whether there are negative interactions with other cancer treatments? And are there certain patients who should avoid the use of cannabis? Dr. Nathan Handley: I would say that in general cannabis can be very safe if taken carefully and appropriately, and ideally with some guidance from a qualified practitioner. But it is important to consider some of the risks and side effects that cannabis carries. So, I think the first point is that if smoked, or otherwise, inhaled, the smoke can have many of the same carcinogens that are found in tobacco smoke. It's also interesting because smoking of marijuana or cannabis and tobacco are highly correlated. And so, it can be difficult for us to kind of assess if there are increased pulmonary risks associated specifically with cannabis use compared to tobacco use. And there have been a number of large cross-sectional and longitudinal studies that haven't found this link between cannabis use and impaired pulmonary function tests or chronic obstructive pulmonary disease (COPD) or lung cancer. But there are still potential risks associated with inhalational forms. There's also some evidence that there may be higher cardiovascular risks among cannabis users, specifically in patients who have heavy cannabis exposure. So, there have been some studies that have looked at the role cannabis can play in thrombosis, inflammation, and atherosclerosis. There have been some case reports that have linked its use to myocardial infarctions and arrhythmias, cardiomyopathy, stroke, and arthritis. But those haven't necessarily been played out in large clinical trials yet. And so, essentially, if someone is at increased cardiovascular risk at baseline, if they're elderly, or if they have pre-existing cardiovascular conditions, these are things worth discussing with the patient. So, I wouldn't say that they're necessarily absolute contraindications. I think some of the more immediate side effects of cannabis are also worth discussing with patients. And these are often related to the amount or the concentration of THC that is present in the preparation. A THC ingestion can result in a number of adverse side effects. There can be impaired concentration, impaired spatial relationships, memory can sometimes be affected. And in some rare cases, you can have increased anxiety, paranoia, or even psychosis. And so, there are not again, strong studies demonstrating a distinct correlation between cannabis use and psychiatric disorders. This is an area that merits further investigation still, and those risks likely vary based on the type of the product, the potency, the composition, if it's synthetic, if it's illicit, but we do have some hesitation about using cannabis in patients who have severe pre-existing mental health conditions like psychosis or schizophrenia, or something like that. On the issue of interactions with certain cancer treatments, I think one thing that patients often wonder is if cannabis can be used to treat cancer? And there is some interesting in vitro data and some in vivo data to suggest that cannabinoids can modulate tumor growth. But the data here is very limited. And so, really what we say is that more research needs to be done in this area. I think the other area of interest is there's some preliminary data, suggesting that patients who are on immunotherapy may have a reduced response to that treatment if they're taking cannabinoids, but these data are also very early. And so, we don't make any clinical decisions based on it at this point. Dr. John Sweetenham: Okay. Thank you. Another area, which I think is concerning certainly to some oncologists and other physicians is the legal issues surrounding the use of medical cannabis. And the core issue there, of course, is the contradiction in many cases between federal and state laws. Dr. Worster, can you tell us a little bit more about this and how oncologists can inform themselves of these issues and perhaps feel a little bit more comfortable about prescribing or recommending medical cannabis? Dr. Brooke Worster: Absolutely. I think at the crux of this issue, you're spot on. I mean, it's muddy. And if you look at the map of our country, the state-by-state variation changes year to year. So, I think one of the biggest things for all clinicians to recognize is that there have been challenges to the legality of recommending, we're not prescribing because that is still federally illegal, but certainly recommending cannabis to patients. There have been legal and court challenges that have worked their way up to federal courts, and have always supported that this is a right to free speech and well within your protected rights as a clinician to have a conversation with your patient along the lines of all kinds of other lifestyle choices we talk about with patients. So, there's no risk in terms of having the conversation, per se, or guiding patients into the space. Where I would tell people to familiarize themselves is really the intricacies of your own state's laws, as well as where a patient may be living if you're seeing them across state lines. One really great resource for this is the National Consortium of State Legislatures. They do a very good job and keep very up to date on a state-by-state basis in terms of what's legal, what conditions, how to access it, if there's reciprocity between states or not, if you can bring product across state lines, who can access it, all of the things that our patients are concerned about, and thus, bringing very valid questions to us that we want to be able to kind of help support them in this conversation. Dr. John Sweetenham: Yeah. Thank you! You know, another issue that you do bring up in your recent article is that of pain management, which of course is a very important component of cancer care in general. But studies in the Journal of Clinical Oncology and elsewhere have recently found there's been a sharp decline in access to opioids among patients with terminal cancer, and some patients have had to turn to hospital emergency departments for pain control. The decline in access has been in part a response to the opioid crisis in the U.S. But do you think this raises an important question about whether we're doing enough to proactively address pain management with some of our patients, Dr. Worster? Dr. Brooke Worster: That's always a really important conversation that we aren't talking about enough. I think, truly, certainly, the pendulum has swung very far to the other side. And in some ways, this is beneficial, because as more and more of our patients with cancer are living into survivorship, we have certainly seen where iatrogenically, we have created dependency and substance misuse issues in the past, and it continues to happen. But I think that we need better ways to have honest conversations with our patients about both. What nuances to their pain exist? Pain is not pain is not pain, right? So, the etiology of their pain is important. And the way that we treat it shouldn't all be the same—neuropathic versus visceral versus a post-operative or inflammatory type of pain certainly should be looked at differently. I think access to opioids is critical for patients with cancer, although it really shouldn't be the only tool in our toolbox. Some of the work that we've done recently, it's interesting. There remains a wide racial gap in terms of access to opioids, as well, as we know this but less well-controlled pain in certain groups of patients with cancer, primarily minority Black and Hispanic patients versus White counterparts. And some of that has to do with the underlying responsiveness to opioids for various people, but also, how much are we talking about it? How much are we having the conversation? Is cannabis a helpful adjuvant, there? Are opioids something that are helpful? It should be talked about and continually readdressed. Dr. John Sweetenham: Thank you. Dr. Handley, Dr. Wooster just mentioned there in her previous comments, the issue of having honest conversations with our patients in the realm of pain control. But on a broader kind of perspective, do you have any recommendations on how to broach conversations with patients about cannabis use as a potential option for symptom management? Dr. Nathan Handley: Yeah, I think that's a really important question. These can be very difficult conversations. Cannabis use is something that is socially, culturally, and regulatory charged. It's very complex. And so, it can be a challenge to have these conversations. I think some general principles about how to effectively engage others, whether they're patients or friends or colleagues can be really helpful. So, I often reflect on this dictum from Stephen Covey, who is the author of this book called, The Seven Habits of Highly Effective People. In this book, he describes the fifth habit as being, “Seek first to understand then to be understood.” So, basically, what he's saying is if your goal is to motivate others, you have to understand where they're coming from before you can meaningfully affect their behavior. So, this sentiment is really a core principle behind the technique called motivational interviewing, which can be very useful to help motivate behavior change in patients and understand where patients are coming from, at the start of a conversation even. So, this technique is really built on 4 foundational principles. And those are acceptance, which is essentially empathizing with the patient, recognizing that they are an important participant in their own care. They're really the driver of their own care. Compassion, which is really emphasizing the well-being of the patient first and foremost. Collaboration, which is partnering with the patient, and not necessarily having a paternalistic relationship with them. And then curiosity, which is about understanding a patient's behaviors and motivations in a non-judgmental way. And so, I think this is really important because it can lead to openness when having a conversation with a patient. So, this has been summed up more simply as “Don't tell. Ask.” So, the idea with motivational interviewing, is you need to be open to understanding where a patient is, and this approach can be taken with 4 steps. So, first, you, you just listen, there's interesting data about how clinicians and physicians spend a lot of time talking in interactions with patients, and not as much time listening. And then we may have a tendency to jump in very quickly and be uncomfortable with silence. And so, this is just a real opportunity to just be open to patients and hear them to understand what pre-existing perceptions they may have. And so, it's hard to have a conversation with a patient about cannabis, if you think that they are going to be very open to it. And it turns out that 5 minutes into the conversation, they have some really deeply held reservations about the use of cannabis. So, first, you engage and listen to them to understand where they're coming from. And then you can focus. You can focus specifically on what the patient's goals are with respect to treatment, with something—in this case with cannabis. What are they hoping to get out of it? Is it improved pain management? Is it some other symptom that they're seeking? And then you can kind of evoke, this next step is evoking what their motivations are? Why do they want to improve this particular component of their treatment? Why did they want to feel better in this way? What are they hoping to achieve? And then, once you've kind of gotten through that groundwork, you can then plan together about how best to approach, in this case, cannabis use, in a way that is mutually agreeable, you can come to a plan together. And this approach epitomizes the concept of shared decision making where this is a conversation that happens together and between 2 people with the interest of the patient kept, first and foremost. Dr. John Sweetenham: Great advice. Thank you! Dr. Worster, just before we close up, you did mention earlier 1 potential resource for oncologists who need guidance on how to safely use cannabis for palliative pain management. Do you have any other recommendations in terms of resources that can be helpful to them? Dr. Brooke Worster: Yeah, absolutely. I wish there were a lot more here. And truth be told, we're still working hard to certainly develop the body of research and then disseminate it in terms of education. But if people are interested, there are increasing amounts of continuing medical education (CME) options that are out there. Each state that has medically legal or medically approved cannabis use on their state websites will have recommended or required depending on which state, I practice in Pennsylvania, and there are required CME courses that you need to take. But all of the states have different ones that are either recommended or required, and that's certainly an easy place to start in terms of some quality education. Thanks to the work that you and others are doing. I think it's certainly coming out through various oncology publications and multimedia access and things like that. And we also have, and some other academic centers around the country now have, online certificate and Master's programs that if people are really interested, they can kind of dive in and take courses or even get a certificate in cannabis medicine or cannabis science, things like that, to help them feel a lot more educated and informed. Dr. John Sweetenham: Well, I'd like to thank you both for sharing your insights with us on the podcast today. And also, for the valuable research that you've been doing on this topic. This is something that I'm sure is going to gain increasing importance to us all in elevating the awareness of this among the oncology community is really important. Thank you for the work that you're doing. Dr. Brooke Worster: Absolutely. Thank you for having us. Dr. Nathan Handley: Yes, thank you. A pleasure! Dr. John Sweetenham: And thank you to our listeners for your time today. If you're enjoying the call sent on the ASCO Daily News podcast. Please take a moment to rate, review and subscribe wherever you get your podcasts.     Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness Dr. Brooke Worster: Consulting or Advisory Role: Ethos Cannabis (Inst), PAX Therapeutics Research Funding: Ethos Cannabis (Inst) Dr. Nathan Handley: Research Funding: Nektar Therapeutics (Inst) 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. 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.        

In a panel moderated by Dr. Karen Knudsen, CEO of American Cancer Society, four leaders in oncology proposed an action plan for tackling cancer health disparities and creating health equity. The panel includes Clifford A. Hudis, CEO, American Society of Clinical Oncology; Executive vice chair, Conquer Cancer Foundation; Chair, CancerLinQ; Chanita Hughes Halbert, Vice chair for research, professor, Department of Population and Public Health Sciences; Associate director for cancer equity, Norris Comprehensive Cancer Center, University of Southern California; Amy E. Leader, Associate professor of population science and medical oncology, associate director of community integration, Sidney Kimmel Cancer Center; Public health teaching faculty, College of Population Health, Thomas Jefferson University; Cheryl Willman, Executive director, Mayo Clinic Cancer Programs (nationally and globally); Director, Mayo Clinic Comprehensive Cancer Center. A transcript of this panel is available here: https://cancerhistoryproject.com/article/experts-propose-action-plan-on-health-equity-panel/

The panel, which met Feb. 23, 2022, discussed the impact of systemic racism, the history of the health equity movement, and the crucial role of mentorship. Panelists: Robert A. Winn, MD Guest editor, Cancer History Project; Director and Lipman Chair in Oncology, VCU Massey Cancer Center; Senior associate dean for cancer innovation and professor of pulmonary disease and critical care medicine, VCU School of Medicine Otis W. Brawley, MD Co-editor, Cancer History Project; Bloomberg Distinguished Professor of Oncology and Epidemiology, Johns Hopkins University Edith P. Mitchell, MD Member, President's Cancer Panel; Clinical professor of medicine and medical oncology, Department of Medical Oncology; Director, Center to Eliminate Cancer Disparities; Associate director, diversity affairs; Sidney Kimmel Cancer Center at Jefferson, Thomas Jefferson University John H. Stewart, MD, MBA Professor of surgery, Section of Surgical Oncology; Founding director, LSU Health/LCMC Health Cancer Center A full transcript of this discussion, as well as a video, are available here: https://cancerhistoryproject.com/article/black-history-month-panel-we-need-to-talk-about-justice/

Dr. Edith P. Mitchell came a long way from growing up on a Tennessee farm, to becoming a brigadier general and serving on the President's Cancer Panel. “It was making a plan, having a plan, and all of us had similar type plans that we needed to leave the farm—yes I grew up on a farm—and get out of town,” Mitchell, member of the President's Cancer Panel, clinical professor of medicine and medical oncology, director of the Center to Eliminate Cancer Disparities, and associate director of diversity affairs at Sidney Kimmel Cancer Center at Jefferson, Thomas Jefferson University. “Yes, you have success, but look back, the students, students, the college students, the medical students, look back and pull somebody behind you, pull them up.” Mitchell spoke with Dr. Robert Winn, director of VCU Massey Cancer Center and Dr. John Stewart, founding director of LSU Health/LCMC Health Cancer Center. When Mitchell attended medical school at Virginia Commonwealth University, then called Medical College of Virginia, she was given a military scholarship and was supposed to give the Air Force two years of service. She became interested in health policy and military medicine and remained in the Air Force. When thinking about retirement after 20 years of service, Mitchell, a colonel at the time, learned she was up for a promotion. The only problem? Her competition, mainly white men, had all been to flight school. “Most people go to flight school in their 20s, right? I was in my 40s with two teenage kids. So what did I do? I signed up for flight school. I finished. I got my flight wings and my certification in aerospace medicine,” Mitchell said. “Very few people know that I am certified in aerospace medicine, but what happened was, I was selected. I am the first woman doctor ever to be promoted to brigadier general in the history of the Air Force.” This story is part of a series of interviews conducted by Robert Winn, guest editor of the Cancer History Project during Black History Month. A transcript of this conversation is available here: https://cancerhistoryproject.com/people/edith-mitchell-on-her-path-from-tennessee-farm-to-becoming-a-cancer-doctor-and-brigadier-general/

Dr Marcia Brose from the Sidney Kimmel Cancer Center in Philadelphia discusses the latest clinical data on targeted therapeutic approaches for the management of advanced thyroid cancer. CME information and select publications here (http://www.researchtopractice.com/OncologyTodayThyroid21/Issue2).

Dr. Ana Maria Lopez, professor and vice chair Medical Oncology at the New Jersey division of the Sidney Kimmel Cancer Center – Jefferson Health, discusses the future of telemedicine in cancer care and how to make it sustainable and accessible to all patients and survivors. Transcript: ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Ana Maria Lopez, a medical oncologist, professor, and Vice Chair of Medical Oncology of the New Jersey division of the Sidney Kimmel Cancer Center, at Jefferson Health.  Dr. Lopez is a member of ASCO's Telemedicine Working Group, and joins me to discuss the future of telemedicine in cancer care and how to make it sustainable in the years to come while striving for quality care for all patients and survivors. Dr. Lopez's full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the podcast can be found on our transcripts at ASCO.org/podcasts. Dr. Lopez, it's great to have you on the podcast today. Dr. Ana Maria Lopez: Thank you so much. Happy to be here. ASCO Daily News: Dr. Lopez, do you think that the COVID-19 pandemic and the increased use of telemedicine will permanently change the way patients with cancer are cared for? Dr. Ana Maria Lopez: You know, I hope so. And the reason I say that is because we've learned a lot. And we've learned that there are ways that we can care for people better at a distance. And so, what we've learned and what we can take forward, I do hope that we'll be able to do. So, for example, we know that a lot of the screening for a cancer clinical trial may be able to be done at a distance. And that way, when the patient actually comes for the appointment, there can be a more rapid entry into the trial. We know that patients may be able to stay at home safely at certain time points--perhaps at time points during survivorship, perhaps if they're doing very well with their treatment. Or if they need an acute assessment, something that needs to be done right away, the camera could be opened, and the conversation can be had. We also have some recent data that being able to care for patients at home may be able to pre-empt some hospitalizations. And to be able to do this with the benefit of telemonitoring, of visual monitoring--that all of these may be very helpful for patients, and may be able to improve their quality of life as well as let us help them with whatever the acute problem is at the time. ASCO Daily News: Absolutely. Those are very positive developments. I know you do have some concerns about disparities in care that emerged during the pandemic. You know, the COVID-19 pandemic exposed a host of disparities in cancer care, including access to telemedicine. During the 2021 ASCO Annual Meeting, you chaired an education session that assessed disparities in digital access and implications for telemedicine. Our listeners will find a link to the session in the transcript of this episode. So, Dr. Lopez, can you tell us about the major barriers to telemedicine that are of concern to you today? Dr. Ana Maria Lopez: Yes. It's really been such a learning experience. You know, telemedicine was really developed to increase access to care. And then to realize during the pandemic that in some situations, telemedicine, telehealth was really a barrier to care. And the reason for that is we used to do telemedicine--for example, a rural patient. The rural patient would go to the local clinic, the local clinic would have this incredible telemedicine setup that maybe included a tele-stethoscope, a tele-otoscope, so that you were really able to do the full exam virtually, with the exception of palpation. And everything was very well set up. But when telemedicine, during the pandemic, really translated--and this began before the pandemic as well, but not to the massive scale. But telemedicine really went to the patient's device. So, the patient needed to have some sort of a smartphone or a tablet, or some device that was connected, preferably, to broadband internet. And not everyone has that. And even if they're in an area where they might have access, it might be spotty in a certain part of the house. Or everybody is trying to get on the network for home schooling, for work. They may not have enough access, enough bandwidth, for the telemedicine appointment. So, access to broadband internet is critical. And then if people had access, their device might not have the right access, or they may not know quite how to get onto their device to get to the telemedicine visit. So digital literacy really came up. You know, we've always talked about literacy. We've talked about numeracy. But now, digital literacy. And we, as clinicians, really needed to advocate for our patients so that they would have the digital literacy to do the telemedicine visit. And I think, actually, also for us, as clinicians, and for the health care team, did education training on the technology, but also on how to engage. You know, there's so many questions that people will have. Well, can I really engage the patient well enough? Can I really make that connection with the patient, which is really what we treasure in the patient/physician relationship? Will I really be able to make that through this machine? And so how can we help people so that they can engage? And again, it may not be the same. But can it provide the care that both parties can really feel, yes, that meets the need at the time? So, I think all of those factors can be important. And they are all, I think, areas that can be overcome. ASCO Daily News: Absolutely. You spoke about access to broadband; you spoke about digital literacy. These things, of course, impact patients in rural settings, [and] older patients. So, it is very important for oncology practices and advocates to be thoroughly aware of best practices, and be knowledgeable about telemedicine tools moving forward to increase access for patients and to help stakeholders learn how to use the tools more effectively. Can you highlight best practices and ways to ensure that clinicians are using telemedicine to best serve the needs of patients and survivors? Dr. Ana Maria Lopez: There's so much in that question. So best practices, I think, we're still learning, which is one of the, I think, great things. I often think of telemedicine as a translational science because we go to the engineers, you know, I've got this problem, and they work it out. And then we can take it back to the bedside, or as some people say, the website, and try it out, really develop these approaches so that they can really help our patients best. But I think what you're pointing to is the real importance of education and training for the clinical teams. Something as simple as, you know, when a patient comes in normally to an appointment, there are vital signs. And again, in the pandemic, in many settings, we didn't have a way to collect those vital signs. So how can we, now that we have our lessons learned, work together to develop processes so patients can do their vital signs at home? Do we send a blood pressure cuff? A pulse-ox often has the heart rate on it. So, do we send these as a little kit? Or do we give these test kits to patients, and educate them on how to take their vital signs at home, so that those data are not missing when we see our patients through telemedicine? I also think when we were talking about engaging earlier, we're taught, in medical school, how to engage with the patient who's sitting next to us. But how do we engage with the patient when our connection is the camera? How do I look at the camera so that the patient--it appears that I'm looking at them, as opposed to looking at their eyes on the screen? So that that's engaging of the patient? I may find myself speaking a little more slowly or pausing more often in order to facilitate that engagement through the telecommunications technology. So, I think there are best practices just from the how to use the technology piece that we need to think about. But also, we need to better understand. What are the areas where telemedicine is most apt? Where do I really feel confident that this is the application to use, and in what situations do I say, you know what? I really need a hands-on approach. And how do I educate so that--let's say I'm following a patient who has a skin lesion. How do I educate the patient to be able to transmit those images faithfully to me, so I can really get a good-quality image, so that my interpretation is clinically appropriate? I think the most important best practice is that we shouldn't think that we're settling. Telemedicine, the technology, has incredible capacity. And if we are ever in doubt as a clinician that, you know, I wish I could do x, or if I had such and such, I would be better able to make this interpretation, if that crosses my mind, then I should see the patient in person. The assessment that I am giving the patient at the time, as a clinician, I should be really comfortable in, whether it's telemedicine, in-person, medicine, telephone, it should really be--I should feel confident. And if I'm not confident, then I should do what I need to do to care for the patient. ASCO Daily News: Absolutely. Is it your sense that oncology practices, [and] smaller community practices, are hearing your call, so to speak, and putting proper trainings in place and follow-up, et cetera? Oncology practices are very busy places. What are your thoughts on this? Dr. Ana Maria Lopez: So, in the same way that--what I said to the med students, you know, is you'll always do the right thing if you put the patient first. Always. Because you'll read, if you're not sure. You'll go talk to a colleague. You'll do what you need to do if you keep your goal the best care of the patient. And similarly, here, if we are going to use telemedicine, then as a clinician, I want to be proficient. I want to do the best job that I can. And so, then I want to get the training that I need in order to get that done. One of the things that we're instituting is, really, new doctors come in. Whenever anybody comes in, you're accustomed to, there is a whole set of learnings that have to happen, right? Because every institution is a little different. And we have our telemedicine trainings that are a part of that. And I think that's really important, because that shows that the health system, that the University system, that the Cancer Center has, as its core, that we understand you may not be 100% proficient at all of this. We don't expect you to. But we expect you to take these learnings and boost your knowledge in this area. ASCO Daily News: Right. In that context, then, of quality care, putting the patient first, how do you think telemedicine will serve patients and survivors in the future? Do you see great improvements in technology? Building better platforms for patients? Do you see these technologies on the horizon? Dr. Ana Maria Lopez: Absolutely. I think we sometimes think, for example--so cancer care. Cancer is a disease, predominantly, of elders, in the sense that as we get older, we're at higher risk for the disease. And as we get older, for example, our eyes age, our hands may become arthritic. Any of these issues could happen to any one of us. And technologies are being developed so that these are easier--so it's easier to maneuver the keypad, so that the lighting is more appropriate. And I think that all patients have a keen interest--and certainly patients that have been diagnosed with cancer--have a keen interest in their health care, and have a keen interest in maximizing their health care. So, bringing to them, you know, here are ways where you can maximize your telemedicine visit is generally very welcome. That sort of education is generally very welcomed by patients. ASCO Daily News: Right. What do you see as the biggest challenges for telemedicine in oncology in the future? There's been the promise of federal funding for these things. What are your thoughts? What what's your checklist for the future? Dr. Ana Maria Lopez: So, one of the things that really helped telemedicine expand as widely as it did during the pandemic and currently is that telemedicine is reimbursed. Very simple. But it's something that we've been working towards for a long time. So, telemedicine reimbursement really needs to continue if telemedicine is to continue. So, advocacy. And ASCO, other professional associations, are certainly at the forefront in advocacy. Reimbursement, tele-education for patients, for clinicians. Broadband, we've talked about. But something that we need to do as a profession is really be able to say, in what way do we want telemedicine to be sustainable in the future? And what will that require? So, for example, things like when patients, let's say, join a practice. Do they receive a telemedicine kit for vital signs? We know, for example, some practices in pediatrics--otitis media are a very common pediatric problem. Parents receive a little otoscope that they can be taught to use, and can have available should they need it. So, for us to really think, what do we need for sustainability? The camera on the phone is now, generally, a pretty high-quality camera. So, in what way can those tools be leveraged to be able to transmit more diagnostic-type images? That's probably not the right term, but images that are of higher quality that one can really make a better interpretation if that is something that's being looked at during a clinical exam. So, we really need to think of sustainability. As you may know, the numbers shot up during the COVID epidemic, the peak of it. We're not past the epidemic. And they have now--telemedicine has not decreased in use in many, many places. So, the easiest thing for us to do as clinical people, as patients, is to just go back to what we're used to. And then we would really lose all the lessons learned. So, I think it's really important to think proactively. Where are the benefits? How can we maximize them? How can we sustain them? ASCO Daily News: You mentioned sustainability. With sustainability in mind, would you agree that further research is necessary to leverage the best of telemedicine in oncology while making changes to improve the patient experience in a sustainable way? And are there any studies, any research, that you're keeping an eye on at the moment? Dr. Ana Maria Lopez: Yes. I think research is critically important to inform telemedicine sustainability, and to think about, really, what are the right applications for future care? And that these are ways, again, to increase access. Fundamentally, this will increase access. So, I think there are many studies to even think of what are the right metrics? What is it that we really are looking at, and what is it that we need to measure? There are things, for example, in cancer care. Cancer care is multidisciplinary by nature. So, there's teleradiology. There's telepathology. In what ways can those services be helpful to the patient, whether the patient is seen in person or at a distance? We've talked a little bit about the access to clinical trials. And again, in what ways can "tele" be integrated in order to increase access to clinical trials? And I think that area, will really blossom. That's an area, again, where hopefully, our lessons learned will not just retreat as something of historical interest. And then is there a right interval, for example, for seeing patients, whether in survivorship, or even during treatment, where you can do an assessment and feel comfortable that if you're doing a visual assessment or if you're doing an assessment that is at a distance with different tools that can do more of the traditional type of physical exam, that we can feel comfortable that that was the right exam? So, these are things that are very concrete, and are very studiable. And I'll give you an example. So, we could have a patient who is being treated for a malignancy. They could have an in-person exam, an in-person assessment, and then they could go into another room and receive a tele-exam, tele-visit, with another clinician. And then the assessments could be compared. Did we get to the same outcome? And is it maybe every other visit that would be comfortable to do at a distance? So, I just think these are really important questions to think about sustainability. And although they may seem very concrete, they're very important to think about how we will carry telemedicine into the future, as well as some of the aspects that we talked about--helping the telemedicine tools be more useful, be more, really, user-friendly for the patient population. And also, to take into consideration that there may be times where the patient, where the clinician, may say, you know, yes, we could do it through telemedicine, but I think it's time for us to see each other face-to-face. And so, too, there's the flexibility to honor the patient's preferences as well. ASCO Daily News: Absolutely. You've raised so many very important [and] interesting points today. Are there any other thoughts you'd like to share before we wrap up the podcast today, Dr. Lopez? Dr. Ana Maria Lopez: One of my favorite images--and I know it's a podcast, so you can't show the image--but there was a cartoon in the front of a magazine that was called “The Radio Doctor.” And I think it was from the 1920s. And I was always so impressed by this because it basically showed a telemedicine setup. And of course, telemedicine didn't happen until much later. And here we are, probably close to 100 years from that image in the front of that magazine, and we're tackling what was visualized, what was envisioned then. So, change, growth, takes time. So, I think that that's really important to remember, that things take time. So sometimes, we may get impatient. At the same time, we want to do it right. And we want to do it with the patient, really, at the center of all of this. So, I very much feel that we've learned a lot of lessons. I look forward to thinking about telemedicine sustainability in cancer care and in clinical care overall. And a part of that work really needs to be working with patients and hearing their voice, and hearing how we can work together so that the clinical experience is as good as [it can be], and there are some data that in certain settings, patients prefer the experience. So, to help us understand what feels better to them, then, and how we can improve the experience overall. So, it's an exciting time. And I look forward to what the future will bring. ASCO Daily News: Indeed. Well, thank you very much, Dr. Lopez, for shining a spotlight on the role of telemedicine in cancer care. Some interesting times ahead. Thank you, Dr. Lopez. Dr. Ana Maria Lopez: Thank you very much. Thank you. ASCO Daily News: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosure: Dr. Ana Maria Lopez: None disclosed. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Veronica Rodriguez-Bravo, PhD, is Assistant Professor, Department of Cancer Biology, at the Sidney Kimmel Cancer Center, Thomas Jefferson University, in Philadelphia, PA, USA. (https://sidneykimmelcancercenter.jeff...) Dr. Rodriguez-Bravo obtained her PhD in Pathology and Cell Biology (Summa Cum Laude) from the University of Barcelona in 2007, where she also received the Extraordinary Doctorate Award for her studies on the distinct DNA replication checkpoint mechanisms of tumor cells. During her postdoctoral training at the Experimental Oncology Department of the University Medical Center of Utrecht (UMC, The Netherlands) and at the Molecular and Cell Biology Programs of Memorial Sloan Kettering Cancer Center (MSKCC, New York), she specialized in the study of chromosome segregation during mitosis and the role of nuclear pores in genome integrity maintenance. Dr. Rodriguez-Bravo's post-doctoral work allowed her to apply genome-editing techniques crucial to dissect the function of mitotic and nuclear pore proteins in chromosomal stability and resulted in the recognition with the Memorial Sloan Kettering Cancer Center Postdoctoral Research Award. Dr. Rodriguez-Bravo's research focuses on the study of genome integrity maintenance mechanisms and the relationship of defects in cell division to cancer pathogenesis with special emphasis in the pathways contributing to cancer cells' more aggressive phenotypes.

On June 27, 2021, our host Dr. Marianne Ritchie was joined by Leonard G. Gomella, MD, FACS, The Bernard W. Godwin Professor of Prostate Cancer, Chairman, Department of Urology, Senior Director Clinical Affairs, Sidney Kimmel Cancer Center, Enterprise VP for Urology, Jefferson Health System and Editor-in-Chief, Canadian Journal of Urology International, Thomas Jefferson University and Hospital.Dr. Gomella provided an update on risks, diagnosis, and treatment for prostate cancer. He will also discuss the symptoms and treatment for an enlarged prostate and explain what to do if a patient sees blood in his urine.​Your Real Champion: Tommy's Gift For Kids​Each week we highlight the #RealChampions in your life! Your family, friends, or colleagues who go the extra mile to help others in their community. For this week, Your Real Champion was Tommy Ricci!Tommy was diagnosed with leukemia when he was 3 1/2 years old. It was the gift of a teddy bear that pulled him through. As a survivor, he provides the same comfort and encouragement to other children facing cancer through his foundation called “Tommy's Gifts for Kids”.

Melanoma is much less common than some other types of skin cancers, but it is more dangerous because it’s much more likely to spread to other parts of the body if not caught and treated early. While there have been some exciting advances in melanoma research in recent years, there is much left to learn about, for example, how it spreads, how it resists treatment, and therapies could be improved. In this episode, three scientists at the Sidney Kimmel Cancer Center who are investigating different aspects of melanoma explain why it’s a challenging disease, describe recent advances against it, and underscore why there are so many reasons to be excited. 4:11 - Andrew Aplin, PhD, is Associate Director of Basic Research at the Sidney Kimmel Cancer Center and Professor in the Department of Cancer Biology. Chris Snyder, PhD, is Associate Professor in the Department of Microbiology and Immunology at the Sidney Kimmel Cancer Center. Neda Nikbakht, MD, PhD, is Assistant Professor in the Department of Dermatology and Cutaneous Biology at the Sidney Kimmel Cancer Center. 4:42 – Dr. Aplin on his research into why melanoma is so resistant to therapy 5:59 – Dr. Snyder on his work into why the immune system sometimes doesn’t seem to recognize cancer 8:11 – Dr. Nikbakht, a dermatologist who sees patients with skin cancer, discusses how she studies the skin microbiome to learn what properties promote melanoma 10:43 – The tremendous recent advances in melanoma treatment 13:59 – What we’ve learned about the immune system in recent years 18:02 – A physician’s perspective on recent advances in melanoma research 22:04 – The big picture goal of Dr. Aplin’s research 26:51 – Dr. Snyder’s move into cancer immunology 32:00 – Dr. Nikbakht on the tremendous importance of patient samples in research 37:46 – How the collaborative environment at the Sidney Kimmel Cancer Center enhances their research 43:26 – The impact of ACS funding on their work 47:16 – Why advances made during the push to develop COVID-19 vaccines could be very impactful for cancer research 49:01 – A message they’d like to share with cancer patients, survivors, and caregivers

On this special episode of Next Question with Katie Couric, Katie dives into a subject very close to her heart: colon cancer awareness. After Katie’s first husband Jay died 23 years ago, she’s been a fierce advocate for early screening and regular colonoscopies — she even, you might recall, got one on live TV. There’s a reason Katie goes to such lengths: early screening saves lives. In this episode, we first hear from a stage 4 cancer fighter who is living that lesson. Then, Dr. Edith Mitchell of the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, helps to answer the question, why are Black people, Black men in particular, so much more likely to get colon cancer and also die from it (hint: it’s systemic). Finally, Katie talks with oncologist Dr. Charlie Fuchs about the state of colon cancer detection and treatment today.  LEARN MORE ABOUT THIS EPISODE:  Visit Stand Up To Cancer, Katie’s cancer-fighting non-profit, for reliable resources and institutions. Take the pledge to get screened for colon cancer Read more about some of the health disparities Dr. Mitchell mentioned, here and here. Watch a video on understanding healthcare disparities in colorectal cancer. GUESTS FEATURED IN THIS EPISODE: Donna Otis, CCM, CCE Chief Executive/General Manager of the Bridges at Rancho Santa Fe, California. Dr. Edith Mitchell, MD, MACP, FCPP, FRCP, is Board Certified in Internal Medicine and Medical Oncology and is Clinical Professor, Department of Medicine and Medical Oncology at Sidney Kimmel Medical College at Thomas Jefferson University and Associate Director for Diversity Programs and Director of the Center to Eliminate Cancer Disparities for the Sidney Kimmel Cancer Center at Thomas Jefferson University. Charles Fuchs, MD, MPH, Global Head of Hematology & Oncology, Product Development, Genentech. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so the data described here may change as research progresses. Cancer does not affect all people equally. Some groups of people, including racial and ethnic minorities, poor people, sexual and gender minorities (LGBT+ people), adolescent and young adult populations, and older adults, are more likely to be diagnosed with cancer, or have poorer outcomes. This is known as “health disparities.” In today’s podcast, Dr. Petros Grivas and Dr. Edith Mitchell discuss health disparities in cancer clinical trials, why it is important for clinical trials to be inclusive, and resources for people with cancer who face barriers to care. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine, and an associate member of the clinical research division at the Fred Hutchinson Cancer Research Center. He is also a Cancer.Net Specialty Editor. Dr. Mitchell is Clinical Professor of Medicine and Medical Oncology at Jefferson Medical College of Thomas Jefferson University, and the Director of the Center to Eliminate Cancer Disparities at the Sidney Kimmel Cancer Center at Thomas Jefferson University. View disclosures for Dr. Grivas and Dr. Mitchell at Cancer.Net. ASCO would like to thank Dr. Grivas and Dr. Mitchell for discussing this topic. Dr. Grivas: Hello. This is Petros Grivas. I'm a medical oncologist at Seattle Cancer Care Alliance. I'm an associate professor at University of Washington and associate member of the Fred Hutchinson Cancer Research Center. I'm real delighted today to be able to discuss with a legend in the field, Prof. Dr. Edith Mitchell. Dr. Mitchell is well-known internationally for her work in oncology as well as health care disparities. Dr. Mitchell is directing the Diversity Services features of the Sidney Kimmel Comprehensive Cancer Center, and is a full Professor there, she is a medical oncologist, as I mentioned. And in addition to many achievements that she has over the years, and her international role in cancer research education and patient care, a few examples of her achievements include that she has been selected to be a member of the President's Cancer Panel and also in the NIH Council of Councils, which speaks highly of her contributions in the field. And I was impressed to find out recently that she was the first woman physician that was promoted to the rank of general in the U.S. Air Force. And again, there're many other accomplishments. Dr. Mitchell and myself have no relevant disclosures in relation to this particular topic that we're discussing today.  Dr. Mitchell, thanks for joining us today. Dr. Mitchell: Well, thank you so much, Dr. Grivas. It's really good to speak with you again, Dr. Grivas.  And thank you so much for the opportunity to discuss disparities with you today. Dr. Grivas: Absolutely. And thank you so much, Dr. Mitchell, for your nice words. We talked a bit about health care disparities. And your work in the field is really, really important. Could you comment a little bit about health care disparities—the definition—and what we mean when we talk about that? Dr. Mitchell: Sure. So when we speak about disparities, it's very important that we understand that for any disease process, whether it's a cancer disease or some other disease, if there are differences among communities, either in the incidence rates, that is, how often the disease or the problem occurs, as well as how often there are deaths. So mortality rates being different in different individuals. Could be men versus women, or Blacks versus Caucasians, or Latinx or other racial or ethnic, or differences even between the South and the North. There are a number of disparities that are different and occur more frequently in individuals who live in the southern part of the country. So disparities meaning that there are differences either in the number of occurrences or incidence rates or in the number of deaths, mortality rates, in different communities and among either a racial or ethnic groups or among people. For example, young patients versus older patients. So evaluating differences that occur among people because of their community. Dr. Grivas: Thank you, Dr. Mitchell. This is very, very helpful to understand. You mentioned some very good examples. Can you elaborate a little bit further about who are the most negatively affected by this, in your opinion? Dr. Mitchell: So it's well-recognized that men have higher death rates from certain cancers. It's also recognized that for the number of individuals that we've collected information about over the years, that African Americans have higher incidence rates of certain cancers and higher mortality rates of others. It's also recognized that African American men have the highest death rates and highest cancer occurrence rates or incidence rates of any group in the United States. So there are a lot of research ongoing now, evaluating men, and particularly African American men, to find out why there is a higher incidence rate and a higher death or mortality rate in this country. So lots of research. There is also a lot of information that over many years, cancer incidence rates have been higher in Blacks compared to whites among males and in whites compared to Blacks among females. So while Caucasian women have higher incidence rates, the African American women have higher death or mortality rates. Also, we have evaluated cancer mortality rates in many different populations and it's still the fact that African American men as well as African American women have higher mortality rates compared to whites. So very important that research continues with those. And for a few cancers, for example, prostate cancer in men, African American men have higher incidence rates of prostate cancer as well as higher death rates. Breast cancer, another area. African American women have higher death rates from breast cancer, although the incidence rates are approximately equal. African American women have more aggressive tumors and more of triple-negative tumors. And triple-negative breast cancer tumors are more aggressive tumors. They spread more rapidly, there are fewer medications to treat the cancers with, and consequently, overall death rate's higher in Black women compared to Caucasian women. Colorectal cancer, another where there are higher incidence rates, with African Americans having a 20% higher incidence rate of colorectal cancer in this country and African Americans having a 40% higher mortality or death rate in this country from colorectal cancer. And then the last that I will mention-- now, I could go on and on with different cancers, but multiple myeloma. Multiple myeloma is probably the most disparate cancer of all of those in the United States. The incidence rate of myeloma in African Americans is twice that of Caucasian patients, and the death rate being even higher than twice as many. So there are so many different-- and consequently, it's important for clinical trials for us to-- understand everything from the preventive strategies and trying to prevent cancer in various populations through early detection and trying to find the cancers at an earlier stage. And the earlier we find the cancer, the better the treatment outcomes and better opportunities for a cancer cure. So really important. And then, of course, there're the diagnostic studies. Treatments can be different in patients and consequently, finding the right treatment for the right patient at the right time being important. Also, we do research and clinical trials regarding posttreatment, quality of care, and survivorship. So really important for individuals to participate in clinical trials so that the patient can have access to and the opportunity to receive the latest information on treatment for this specific cancer as well as follow-up diagnostic studies, the specific scans, or other markers.  There, actually, Dr. Grivas, is a study ongoing where individuals may participate in a study even before they develop cancers or chronic diseases. And that's called the All of Us study. With All of Us, it is planned that approximately 1 million participants will be invited to participate in this trial, and information regarding a specific participant or a specific individual can be given back to the patient or the individual. Like I said, many individuals will not have developed a cancer or a chronic disease. And this might help individuals determine what the risk factors are for developing certain tumors over a period of time. So All of Us is another study by the NIH that will help determine risk factors for patients. So I think for every patient to try and find out information, 1, regarding the tumor if they have developed a cancer but, 2, determine screening strategies to try and find the tumor at an earlier stage and then opportunities for participation in prevention trials to try and prevent cancers from forming. So lots of different clinical trials ongoing and very important for specific populations. It's well-recognized that African Americans have higher incidence and mortality rates. Latinx or Hispanic patients, there are some tumors that have higher incidence or higher death rates. And the Native Americans also, for certain tumors, have higher incidence rates and higher death rates. So so much in terms of clinical trials ongoing and especially for minority populations. Finding out information about a clinical trial and the opportunity for participating in a clinical trial, very important. Dr. Grivas: These are excellent points, Dr. Mitchell. I want to ask you to comment a little bit on the efforts overall and your role in National Cancer Institute and other forums. What is the oncology community's trying to do to reduce these disparities? You mentioned clinical trials as a main important topic. But what resources are available to the patients in order to try to avoid those barriers and enroll in clinical trials and eliminate disparities in patient care? Dr. Mitchell: Certainly. And that's a great question because individuals can, if there is access to the internet, go into clinicaltrials.gov. One can find information about trials as well as potentials for treatment trials and just basic information about the disease process. So if there is breast cancer, you can type in "breast cancer," and you'll get the information on breast cancer or any specific cancer. And I urge patients not to just go to the internet and look for things but go to the NIH or the NCI websites. Those are the areas where the greatest research has occurred, and this is research that is specifically targeted for the United States population. So we do provide that information. We also provide information that patients can give to their physicians and ask questions. Always ask questions to your physicians or other clinical staff. The nurses are great resources of clinical information. It's always good to ask those questions. And if you use the internet, go to clinicaltrials.gov, and you will get the latest in terms of the National Cancer Institute studies. But you can also get information regarding the disease processes. And another good site is that of the American Cancer Society, which also has outstanding patient information that is reliable and trustworthy. So I usually recommend those 2 sites, but there are others. And especially if there is a National Cancer Institute-designated cancer center in the area. These are funded by the Congress and therefore are excellent areas for information as well as treatment. So I do recommend that patients utilize these resources instead of routinely just clicking on the disease process and seeing whatever comes up on the internet. There are some resources on the internet that are not reliable, that are not clinical trials, and I advise patients to be careful about obtaining information on the internet, and make sure it's from a trustworthy resource. Dr. Grivas: These are great points, Dr. Mitchell. I appreciate all your work you have done in the field. That's one of the very valuable points for our audience today. I think the take-home message is for our patients and audience participants to ask questions, seek opportunities, make sure they discuss with their treatment providers about clinical trial opportunities for them to be involved in the research and clinical trials. As you mentioned, that's the way to move forward as well as to eliminate disparities in health care. So thank you so much again for your time today and your so-important insights for our audience. Thank you, Dr. Mitchell. Dr. Mitchell: Oh, thank you so much, Dr. Grivas, and we look forward to working with you on the various projects that we have. And the last thing I'd like to say for patients, that despite the COVID-19 pandemic and the number of patients affected, if 1 has symptoms, then they should still discuss this with their clinicians and go in for cancer screenings, go in for cancer treatment. And if there are questions, talk with your physicians about it. Because although the coronavirus is here, cancer doesn't go away. So we still have to address cancer despite the COVID-19 pandemic, which affects so many Americans. But cancer is not going away. So still talk with your doctors about cancer screening and cancer treatment. Thank you. Dr. Grivas: Fully agree with you. Great point. Absolutely. And thank you for pointing this out to avoid delays in cancer diagnosis, avoid delays in screening and proper workup. Thank you so much, Dr. Mitchell, for your time today. ASCO: Thank you, Dr. Grivas and Dr. Mitchell. Learn more about cancer disparities at www.cancer.net/disparities. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. This Cancer.Net podcast is part of the ASCO Podcast Network. This collection of 9 programs offers insight into the world of cancer care, covering a range of educational, inspirational, and scientific content. You can find all 9 shows, including this one, at podcast.asco.org. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/donate.

Alan Phillips, a patient from Jefferson Health in New Jersey, knew his cancer care couldn't wait for the end of the coronavirus pandemic. Masked, sanitized, and ready to go, he continued his chemotherapy treatments during a time when many patients chose to avoid the hospital setting for fear of the coronavirus. Alan says he felt safer in the hospital than he did in most places in the community. His treating physician, Dr. Ana Maria Lopez, medical oncologist from the Sidney Kimmel Cancer Center at Jefferson Health, said this continuation of care could mean a world of difference in his outcome.    The National Cancer Institute forecasts 10,000 additional deaths from breast and colorectal cancer over the next 10 years due to failure in receiving care. Hear more from Alan on what his experience was like and why it's important to seek the necessary medical care you need, even during this time of uncertainty.   Check out TheHealthNexus.org for more content on the coronavirus, like a patient's guide to going to the doctor during the pandemic and a story from a Jefferson patient who had surgery for thyroid cancer during the coronavirus.   Also, read an article with insight from Dr. Ana Maria Lopez. Follow Jefferson Health @TJUHospital on Twitter, @JeffersonHealth on Instagram and @JeffersonHospital Facebook.

This episode takes on a topic from recent headlines--namely, the racial disparity in COVID-19 cases and deaths. Edith P. Mitchell, MD, MACP, FCPP, shares her insights on the causes of these health disparities and how they relate to the coronavirus. Contributing factors include less access to testing, lack of insurance and paid time off, underlying health conditions, and the spread of misinformation about the virus.She also touches on how racial disparities affect clinical research. “When I came to Philadelphia, we had only 7.8% participation by African Americans in clinical trials. Yet 45% of Philadelphia is African American. We have been able to raise the participation in clinical trials to a high of 24.9%, and maintain a range around 20%,” she tells WCG President of Patient Advocacy Steve Smith. “Never assume African Americans don’t want to participate in clinical trials. They must be invited, and there must be cultural competence among healthcare providers.”Dr. Mitchell is clinical professor of medicine and medical oncology, Department of Medical Oncology; director, Center to Eliminate Cancer Disparities; and associate director, Diversity Affairs, at Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. She is also a retired U.S. Air Force Brigadier General.

Kristen is joined in studio by Anya Taylor Joy, who starred in 2015’s The Witch and the M. Night Shymalan films Split and Glass, among others. She’s here promoting her latest film, that Kristen (a lifelong Jane Austen fan) is VERY excited about. Anya plays the title character of Emma, in the new film Emma, based on the Jane Austen classic. The two chat about bees in bonnets, intricate costumes, the comedy throughout, and the film’s amazing supporting cast. Be sure to catch Emma, in theaters NOW. It’s the best adaptation yet!  Then Melissa Demyan, owner of Astra Event Planning joins Kristen to talk about the 4th Annual Striking Out Cancer event happening next Saturday, March 7th from 1 to 4pm at the Chickie’s and Pete’s in South Philadelphia. This celebrity bartending event raises funds for the Sidney Kimmel Cancer Center, and surprises a cancer patient each year with a trip to Spring Training in Clearwater with the Phillies. This year’s trip recipient is Andy Sealy, who will be headed to Clearwater in March. Hear more about Andy's story, and incredible outlook, in her podcast Making the Breast of It. https://podcasts.apple.com/us/podcast/making-the-breast-of-it/id1481022121. Your ticket to Striking Out Cancer buys you appetizers and unlimited drinks with celebrity bartenders, including Kristen Herrmann from BEN-FM, Matt Cord from WMGK, Nicole Michalik from WXTU, Mike Missanelli from WPEN, and Mike Jerrick from Fox 29. There will also be a silent auction with some great prizes and raffle items available. Buy tickets to Striking Out Cancer at https://www.astraevp.com/striking-out-cancer.html.  Next Gavin O’ Conner, the Director of the classic Disney hockey film Miracle, the movie Warrior, the critically acclaimed film The Accountant and so many other great films joins Kristen to talk about his latest film, which hits theaters next week. The Way Back has all the things you’d expect in typical sports movie, and more. The film stars Ben Affleck as Jack Cunningham, now an adult, but a former high school basketball star. Jack's life at times seems to parallel Ben Affleck's own personal life. Jack is dealing with a personal tragedy, and his recent separation from his wife. Jack is taken out of his isolation and comfort zone, when he's asked to coach a high school basketball team. In a way, the kids help to coach him too. Go see The Way Back when it hits theaters March 6th. 

TRANSCRIPT Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll. The Genitourinary Cancer Symposium hosted by ASCO in San Francisco revealed some significant clinical developments, and here to discuss key takeaways from the meeting is Dr. Karen Knudsen, program chair of the symposium. Dr. Knudsen is the enterprise director of the NCI-designated Sidney Kimmel Cancer Center at Jefferson at Thomas Jefferson University and Executive Vice President of oncology services at Jefferson Health. Dr. Knudsen, welcome to the Daily News Podcast. Dr. Knudsen: Thank you so much for having me. It's really a pleasure to get a chance to discuss all of the things that were revealed at the 2020 ASCO GU. ASCO Daily News: Dr. Knudsen, do you have any conflicts of interest that you'd like to disclose, which are relevant to our conversation? Dr. Knudsen: If I do have conflicts of interest, I don't think they're relevant for the conversation. But I like to disclose them anyway. As the cancer center director, it's something all of us are trying to pay more attention to. So I do have advisory and consultant positions with CellCentric and Genentech. I've had ad hoc advisory board positions in the last two years with Sanofi, Janssen, Novartis, and Celgene, and research support from CellCentric and Celgene. ASCO Daily News: All right, thanks Dr. Knudsen. Well, the Genitourinary Cancer Symposium showcased a lot of interesting presentations and insights on topics across GU malignancies. So what are your key takeaways from the meeting? Dr. Knudsen: So this was really an exciting meeting for us, and the way that we put together the program was aligned to our theme, which is, in pursuit of patient-centered care. And the program committee and steering committee really worked together to try to decide how the 2020 program should come about. And it was to take all of the things that were and are fantastic about ASCO to you and take it even further in a couple of different directions. Dr. Knudsen: One is to incorporate really the latest science, the latest evidence for some of the new agents and new interventions that we're seeing develop for GU malignancies, and also look to the future of things that are coming. The second was an emphasis on multidisciplinary teams, so effective integration of urology, medical oncology, and radiation oncology as related to GU cancers, but also the translational science behind the new findings and seeing those come together. Dr. Knudsen:  And then the last was a focus on quality of life. As we've had all these new interagents and new interventions introduced over the last few years in the GU malignancy field, we felt it was really important for us to ensure that we're addressing impact on quality of life, including but not limited to financial toxicity throughout the meeting. And I think those elements were really achieved by dissection of the program, but also, we've heard just tremendously positive feedback from attendees about that additional incorporation and thoughtfulness within the meeting. Dr. Knudsen: So you know, kind of keeping that in mind, I think that some of the key takeaways are that the pace of our field is really moving quickly with regard to innovative imaging, combinations, especially novel combinations using immunotherapy as a backbone. We heard about new endpoints, PSS2, new biomarkers, and incorporation of targeted agents. So across all of the GU malignancies, there was this feeling that the pace has really accelerated for new opportunities for detection and intervention. Dr. Knudsen:  In order to also really address what some of those new possibilities are, we had something quite different this year. We had the FDA with us in a, quote unquote, meet the regulators session to talk about some of these new technologies, new endpoints. And they actually walked us through a previous example of something that had come to light in the last few years in the GU field, which is incorporating the MSF or metastasis-free survival endpoint into GU malignancy trials. And that was a really important one. Dr. Knudsen: We also had some great reminders about how to ensure that our science and our clinical trials are tending to both statistical and clinical relevance. Fantastic statistical talk from Dr. Sides, who walked us through some of the ways that we can sharpen our focus on ensuring that we're drawing the right conclusions from the trials and the preclinical studies that we cover. Dr. Knudsen: And attendant to the theme of the meeting, we had a really fantastic keynote lecture from Dr. Dave Penson at Vanderbilt on financial toxicity and the impact on quality of life, as well as other endpoints, including patient-related outcomes and the overall outcomes from new interventions. He educated us about coping behaviors that patients engage in that may shift their compliance for cancer care and certainly, as may be related to other adverse events, and really shared with us some striking data about the number of patients that may be depleting their total net worth after a cancer diagnosis. So that part was really a call to arms to have all of us help attend to educating the patient as much as possible about financial ramifications, as well as other ramifications of therapies as they're introduced. So really, fantastic science, moving very quickly, and now we're ready to address some of the other ramifications of the newer interventions that we're introducing. ASCO Daily News: Speaking of new interventions, were there advances reported that would likely support new standards of care moving forward? Dr. Knudsen: There were. I think there-- you know, there were a number of advances that we're going to want to really track carefully over this next year. So advances in imaging were prominently discussed at the meeting-- when to use next generation imaging and taking into account disease state and clinical scenarios. Advances in standard of care are likely to also include-- we heard a lot about this at the meeting-- an increased incorporation of genetics, including both somatic and germline alteration. Dr. Knudsen: Dr. Castro gave us a really fantastic talk about the importance of profiling both somatic and germline alterations in patients, especially patients with advanced disease or who are at risk for aggressive disease, and showed us some compelling data about the limitations and ramifications of only looking at one, either somatic or germline. And that's probably not serving the patient as well as we could-- and gave us some very strong examples, especially with regard to DNA repair mutations, about how to incorporate this and to tailor therapy. Dr. Knudsen: I think that we'll see some changes coming in the future with regard to gene signatures and biomarkers. For example, even just in the prostate space, we heard about a 22 gene signature from Dr. Feng, which may predict who is going to need more aggressive care, as well as from Dr. Klotz with regard to non-coding RNAs and their ability to predict prostate cancer behavior. Dr. Knudsen: So this is actually a really interesting session, because we got into the dynamics of how we actually bring this to a change to [INAUDIBLE] where one of these signatures become standard of care, given the long-term follow-up that's really required to understand how these signatures inform prostate cancer behavior. So there was actually quite some healthy debate on that within the ASCO GU meeting. Dr. Knudsen: More forward thinking to later on was with some discussions with Dr. Beltran on epigenetics and how that may additionally influence our ability to predict behavior. But I think what I would say is probably the third and really interesting advance that we heard about at this meeting was our ability to use liquid biopsy and to have cell-free DNA or circulating tumor DNA inform the mechanisms of resistance that may be emerging in a particular tumor, and how we may treat that patient by anticipating and forwarding resistance. So a lot of really fantastic talks incorporated ctDNA into their discussions. Dr. Wyatt really stands out there in one of his discussions about the limitations of using circulating tumor DNA, but how promising this is with regard to giving concordance with what tumor lesions actually look like. So these are some technologies that are not quite ready yet to be incorporated as standard of care, but it's coming quickly. Dr. Knudsen: The future is really near, and so those are, I'd say, were some of the forward-thinking things that we really discussed, which, of course, complemented the exciting trial data that we saw, things that have been reported out and are likely to give new approvals and new interventions for GU malignancies in the near term. ASCO Daily News: You spoke about the prostate space a few moments ago. So I'm wondering, did any GU fields stand out more than others at this meeting? Dr. Knudsen: You know, I think each of the fields have had significant progress, as evidenced by some of the clinical trials that we heard about. So for example, in the clear cell renal carcinoma space, there was a lot of excitement over Dr. Choueiri's talk looking at a new target. So there was a Phase 1/2 trial for a first in class agent that's targeting a protein called HIF-2 alpha. And utilization of this oral HIF-2 alpha inhibitor and advanced clear cell renal carcinoma. Dr. Knudsen: So in this particular study, this new agent and the idea of targeting HIF-2 alpha actually emanated from what was the basis of the Nobel Prize in this last year with regard to understanding the factors that drive hypoxia and that are so important in this disease. And what was really remarkable about that Phase 1/2 trial is that there were objective responses seen in all of the different risk categories. So of course, the favorable category, but also the intermediate and poor risk category patients benefited from this agent. Dr. Knudsen: And so this is really, I think, one to watch. There's a large Phase 3 trial, as we understand it, on the way for this agent. So you know, clear cell-- that was just one of the things that we talked about. In the bladder cancer space, there was the NEOBLADE study, which is a neoadjuvant chemotherapy study, which was really interesting and was the basis of a lot of discussion as well, because the primary endpoint may not have actually achieved the benefit, which is a path CR. But there was improved PSS and overall survival as well in those patients. So that's also something really for us to watch and gives us new thoughts about what neoadjuvant chemotherapy might look like in bladder cancer. Dr. Knudsen: Another trial I think that was really interesting was the STOMP trial from Dr. Ost. So the primary endpoint for this study was something we don't always think about, which is androgen deprivation therapy free survival. That was really what was being tracked. And this is an interesting trial design. It wasn't designed to actually change practice, but to lay the foundation for a large Phase 3. And really, the question there for which the evidence looks quite interesting is, does metastasis direct to therapy improve this endpoint? Does ADT free survival? So I think that's one that was very forward-thinking type of strategy. Dr. Knudsen: And then not to underserve radiation oncology, because it was also featured very prominently at the meeting, and there were a lot of exciting results in a number of different formats. But the chip trial reported this long-term follow-up of a Phase 3 study looking at conventional versus hyperfractionated high dose radiation therapy in prostate cancer. And this was really a really good news outcome in that type of fractionation strategy appears to continue to be effective in these patients that require long-term follow-up. And certainly, prostate cancer at this stage is that category. So large number of trials that are on the cusp of being practice changing, and I just got a chance to mention a few. But in my view, all of the GU malignancies had these kinds of breakthroughs throughout the meeting that were reported. ASCO Daily News: That sounds very promising. And just finally, are there any other new agents in development or treatment approaches that really caught your attention and looked promising for the future? Dr. Knudsen: Yeah, I think there are. So in the prostate cancer space, there was significant discussion-- And this, I'm sure, will continue into GU ASCO 2021-- about the treatment of oligometastases and that oligometastases are really not the same as low volume disease. And that is going to be increasingly important for us as a field to understand the biology of oligomets. This may cause us to really redefine, as we can now image oligometastases much better with PSMA, attached agents just to redefine the M0 state and reexamine our thoughts about the trials that have happened in the past, or, perhaps, these patients actually were not at the MDR stage. Dr. Knudsen:  So that's one part of the oligometastases story. The other is, what is the impact of treating oligometastases? This is really where I think the field is moving. It's grappling with understanding that, and getting those trials to start to report out, I think, is going to be a really important thing for us to watch. In the muscle invasive bladder space, we talked and heard about the BLASST-1 trial from Dr. Gupta, which I think was also pretty exciting, exciting results with neoadjuvant, nivolumab, which [INAUDIBLE], and there was a report of the PCR in almost half of those patients. Think it was just under half of those patients-- really exciting. Dr. Knudsen: SGFR3 got a lot of discussion as a new target for bladder cancer, and there's a preview of what a Phase 3 trial might look like. But then there are also some studies that were really back to basics. They were incredibly important. So Dr. Plimack from Fox Chase Cancer Center here in Philadelphia gave a spectacular talk on side effect management. And this was for frontline treatment of renal cell carcinoma. Dr. Knudsen: And what she reminded us of is something incredibly important-- that strong side effects management, effective side effects management keeps patients on therapy and keeps them responding longer, and that we should not really undervalue this. It's something that's an important aspect of managing patients with advanced GU malignancies. And so as much as breakthroughs of new targets, new combinations, new ways to treat, new ways to image, but also, back to the patient centricity. Managing-- in this case, managing their side effects is a great way to get a better outcome. So important things to remember. ASCO Daily News: Absolutely. Well, I want to thank you, Dr. Knudsen, for sharing these interesting highlights from the GU Cancer Symposium. Dr. Knudsen: My pleasure. ASCO Daily News: And to our listeners, thank you for tuning in to the ASCO Daily News Podcast. If you're enjoying the content, please rate and review us on Apple Podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. The following represent disclosure information provided by the guest(s) of this podcast: Dr. Karen Knudsen Consulting or Advisory Role:  CellCentric and Genentech. Ad hoc advisory board positions in the last two years with Sanofi, Janssen, Novartis, and Celgene, and research support from CellCentric and Celgene.  

Vice President of Google Health, Dr. David Feinberg, talks with StartUp Health Chief Medial Officer, Howard Krein, MD, PhD, on the main stage of the StartUP Health Festival in San Francisco. January 14, 2020. Dr. David Feinberg has spent his entire career caring for people's health and wellbeing. And after years in the healthcare system, he now leads Google Health, which brings together groups from across Google and Alphabet that are using AI, product expertise and hardware to take on big healthcare challenges. (https://www.blog.google/technology/he...) Dr. Howard Krein is the Chief Medical Officer of StartUp Health, which was founded in 2011 to invest in a global army of entrepreneurs, called Health Transformers, committed to achieving health moonshots. Dr. Krein is also an Assistant Professor of Otolaryngology: Head & Neck Surgery at Thomas Jefferson University and a founding partner and co-director of Jefferson's Facial Aesthetic and Reconstructive Center. Additionally, he is the Senior Director of Health Policy & Innovation at the Sidney Kimmel Cancer Center. From 2017 to 2019, Dr. Krein served on the Biden Cancer Initiative's Board of Directors. Dr. Krein is part of an exclusive group of physicians with two doctorates, receiving his MD from Thomas Jefferson Medical College in Philadelphia and a PhD in Cell and Developmental Biology from UMDNJ/Robert Wood Johnson Medical School. Dr. Krein completed internships in both Emergency Medicine and General Surgery, a residency in Otolaryngology: Head and Neck Surgery at Thomas Jefferson University Hospital in Philadelphia and a Fellowship in Facial Plastic and Reconstructive Surgery at Medical College of Virginia in Richmond Virginia. He earned his Bachelor's degree in Biology and a Master's degree in Neuroscience from Rutgers University. Dr. Krein lives in Philadelphia, PA. Entrepreneurs: How to get investment from StartUp Health https://www.startuphealth.com/ Investors: How to invest in StartUp Health Moonshots http://www.healthmoonshots.com Want more content like this? You can subscribe to the podcast as well as other health innovation updates at startuphealth.com/content. Sign up for StartUp Health Insider™ to get funding insights, news, and special updates delivered to your inbox.

Dr. Costas Lallas joins the Urology Care Podcast to discuss Immunotherapy for Urothelial Cancer. Dr. Lallas is Professor and Vice Chair of Academic Programs in the Department of Urology with Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital in Philadelphia.

ONS member Michele Gaguski, MSN, RN, AOCN®, CHPN, NE-BC, APN-C, cancer program administrator at the Sidney Kimmel Cancer Center in Sewell, NJ, joins Chris Pirschel, ONS staff writer, to discuss the goals and objectives of the Magnet program, how it benefits nursing practice, and what ONS resources are available to help institutions achieve Magnet status. Music Credit: "Fireflies and Stardust" Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0 Episode Notes: Check out these resources from today's episode: Complete this evaluation for free nursing continuing professional development. ONS Global Initiatives ONS Competencies ONS Congress ONS Position Statements ONS Putting Evidence Into Practice ONS Standards and Guidelines Episode 24: How Publishing Can Advance Your Nursing Career – Part 1 Episode 25: How Publishing Can Advance Your Nursing Career – Part 2 Episode 36: The Power of Presentation—How to Develop Public Speaking Skills How Great Nursing Improves Doctors' Performance

ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so the data described here may change as research progresses. While most people may think of visiting a doctor to receive medical care, today, technology such as computers and smartphones can connect doctors and patients who are separated physically. This is known as “telemedicine.” In today’s podcast, Dr. Ana María López, Dr. Joseph Sirintrapun, Dr. Joseph Greer, and Dr. Karen Edison will discuss their article from the 2018 ASCO Educational Book, “Telemedicine in Cancer Care,” including specific methods used in telemedicine, and the ways it helps bring high-quality medical care to people who might not otherwise be able to access this care. Dr. Lopez is the Vice Chair of Medical Oncology and Chief of Cancer Services at the Sidney Kimmel Cancer Center at Thomas Jefferson University. Dr. Sirintrapun is a pathologist and the Director of Pathology Informatics at the Memorial Sloan Kettering Cancer Center. Dr. Greer is the Clinical Director of Psychology and a research scientist in the Center for Psychiatric Oncology & Behavioral Sciences at the Massachusetts General Hospital Cancer Center. Dr. Karen Edison is the Philip C. Anderson Professor and Chair of the Department of Dermatology at the University of Missouri Health System, the Medical Director of the Missouri Telehealth Network, and the Director of the Center for Health Policy at the University of Missouri. Published annually, the Educational Book is a collection of articles written by ASCO Annual Meeting speakers and oncology experts. Each volume highlights the most compelling research and developments across the multidisciplinary fields of oncology. ASCO would like to thank Dr. Lopez, Dr. Sirintrapun, Dr. Greer, and Dr. Edison for discussing this topic. Dr. Lopez: Hello, welcome. My name is Dr. Ana María López. I’m a medical oncologist at the Sidney Kimmel Cancer Center at Thomas Jefferson University. Today we have a great panel on telemedicine and cancer care. I’m joined by Dr. Joseph Sirintrapun from Memorial Sloan Kettering Cancer Center, Dr. Joseph Greer of Massachusetts General Hospital, and Dr. Karen Edison from the University of Missouri Health System. In this podcast, we will be sharing some key points from our 2018 ASCO Educational Book article, “Telemedicine in Cancer Care.” I’d like to start by giving a quick overview of telemedicine. Telemedicine uses telecommunication technology, like smartphones and computers, to provide clinical care, to really facilitate access to clinical care. These virtual visits can be in real-time, that is, almost like the face-to-face visits, and the patient and the physician use a video connection, which could be an app. But it could also be done by utilizing what’s called Store-and-Forward. So when medical reports are transmitted, when images, like radiographs, or sound recordings, which might be from an echo, or a stethoscope, could be transmitted, and these are interpreted at an asynchronous time from the clinical visit.  A combination of these approaches can often be used. And although these have been developed to care for patients at a distance, you can image that this can be very helpful in urban settings as well. Dr. Edison, can you tell us a little more about the history of telemedicine and how it might benefit patients with cancer? Dr. Edison: Of course, Dr. Lopez. Telemedicine was initially created to assist with the care of astronauts while they were in space. But since devices like smartphones and computers with video capabilities have become so widespread and popular, doctors are now finding that they can use telemedicine to benefit patients who may not be able to otherwise make an in-person visit. Teleoncology, which is the cancer-specific form of telemedicine, was first used to help treat patients with cancer who live in rural areas. Teleoncology became a useful way for them to get care from their cancer team. Dr. Lopez: Dr. Edison, do you think teleoncology as effective as seeing a cancer doctor in person? Dr. Edison: Yes, and this has actually been studied. Telemedicine is as effective as in-person care, and both patients and doctors are highly satisfied using telemedicine. It also saves costs. Dr. Lopez: What do you think these different types of telemedicine applications—you see these mHealth apps and wearables—can they help people with cancer? Dr. Edison: Using telemedicine technologies like remote monitoring of cancer patients is a way to limit the time that patients with cancer spend in the doctor’s office or the hospital so that they can maximize their time closer to home enjoying their lives. With telemedicine a patient can follow up with me on wound care and talk about managing their symptoms without making a trip to the office. I can use telemedicine technologies to monitor my patients’ vital signs, like temperature and heart rate. There are also iPad-based group therapy sessions for young adults with cancer, and even a smartphone attachment that can use digital images to assess the cervix after an abnormal screening. Dr. Lopez, you’ve done a lot research into using teleoncology for breast cancer care, can you tell us a little about your patients’ experiences using these methods? Dr. Lopez: Sure. You know, teleoncology for breast cancer care, and for different aspects of cancer care, as you were mentioning, can really encompass the full spectrum of care from prevention, survivorship, to palliation. There are data for the efficacy, for example, of telegenetics to assess hereditary cancer risk. And with the limited access for cancer geneticists in the country, this is really of great value to communities. There are approaches where telemedical services could be “bundled.” This could facilitate entry into breast cancer care by coordinating timely scheduling, sometimes even same-day. Telemammography, telepathology for the breast biopsy, and teleoncology consultation to discuss the plan of care, all really to facilitate the patient’s care. At the end-of-life, the opportunity for tele-hospice can facilitate connection to care, timely assessment and intervention, and ease symptom management. A unique application for telemedicine that was pioneered at our institution in Arizona is for virtual rounds, to engage the patient, families, and caregivers in the transitions of cancer care that are critical for patient outcomes. Although most telemedicine approaches serve to bring the patient to the medical team, the concept of virtual rounds serves to bring the family and caregivers to the medical experience and to the discussions that can support care transitions. So as we consider how to care for patients, and to better care for cancer patients, we can also think if there is a technological approach that could make care easier. That might just be a telemedicine solution! As an example, Dr. Sirintrapun at Memorial Sloan Kettering has used telemedicine to address an important approach in telepathology. Dr. Sirintrapun, can you tell us a little more about this? Dr. Sirintrapun: Of course, Dr. Lopez. Pathology is the examination of tissue, the mainstay being under a microscope. As a pathologist, I diagnose cancer or determine if the tissue is free of disease. Pathology is constrained historically because of the requirement for the physical presence of someone who is skilled at microscopic examination. There are scenarios where there cannot be enough of these people available to render an accurate microscopic assessment. This absence is particularly true outside the U.S. where there is an ever-expanding shortage of pathologists and where patients are unable to receive a definitive pathologic diagnosis. I described a specific situation at my institution where there were not enough skilled people at our satellite locations evaluating fine needle aspirations and biopsies for adequacy. This unavailability might have resulted in patients sometimes having to undergo multiple subsequent biopsy procedures or invasive procedures. Dr. Lopez: Oh, how interesting, that’s certainly not the experience we want our patients to have. How has you worked to change this? Dr. Sirintrapun: In a nutshell, because telemedicine or telepathology can cut out the need for physical transport and manual handling of glass slides and patient information, I created a telepathology framework to overcome the need for physical presence of someone skilled at microscopic evaluation. We’ve been able to use remotely operated robotic microscopes and microscopes streaming high-definition video to evaluate tissues at other locations and communicate our findings. Dr. Lopez: That’s great! Thank you, Dr. Sirintrapun. Dr. Greer, what are some other ways that telemedicine can help patients with cancer? Dr. Greer: Yes, the change from using paper medical records to electronic health records is a big development. The goal is to be able to virtually link a patient’s medical record with mHealth tools in their home. For example, this could include a camera equipped with secure software to assess skin changes and rashes associated with chemotherapy or radiation, or computer-based interactive tools to assess symptoms related to cancer care in real time. Also, many patients in rural areas are not able to enroll in clinical trials. Telemedicine may be used to facilitate access to cancer clinical trials by virtual eligibility assessment, consent, and symptom assessment and management. It evens out the access to the benefits of clinical trials between urban and rural patients. Dr. Lopez: And what about big data? That’s a term that we hear a lot about in the news. Dr. Greer: Yes, big data is one of those hot terms. Essentially, it means that we can use electronic health records, without any patient-identifying information, to amass a lot of medical information on a lot of people. Then, we can use computer algorithms to find patterns across the population to more effectively diagnose and treat cancer. Dr. Lopez: Thank you, Dr. Greer. And thank you Dr. Edison and Dr. Sirintrapun. Technology is a tool that may free the doctors to focus on patient care and allow patients to more easily communicate with their medical team. We may see improved coordination of cancer care, lower costs, time savings, early disease detection, and increased access to care, education, and personalized care through telemedicine and teleoncology. We appreciate your time and sharing your wisdom with us, and we appreciate the time of all the listeners, and look forward to hearing of your experiences as you explore these opportunities. Thank you. I hope you’ve enjoyed our podcast. To learn more, please view our article online at ASCO.org/edbook. Thank you. ASCO: Thank you Dr. Lopez, Dr. Sirintrapun, Dr. Greer, and Dr. Edison. Please visit ASCO.org/edbook to read the full article. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play. Cancer.Net is supported by ASCO’s Conquer Cancer Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/support.  

First on the show this week is Janine DeFeo, co-founder of the Teal Butterfly Challenge. The Teal Butterfly Challenge is a non-profit 501 (c3) organization whose mission is to raise awareness about the early signs and symptoms of ovarian cancer by educating the public through community events and social media campaigns. September is Ovarian Cancer Month so the Teal Butterfly Challenge encourages people to paint their nails teal and make a butterfly sign with your hands and post on social media with the hashtag #tealbutterflychallenge to raise awareness.  For more information you can visit www.tealbutterflychallenge.com Next on the program is Karen Knudsen, PhD, Enterprise Director of the Sidney Kimmel Cancer Center at Jefferson Health and Editor-in-Chief of Molecular Cancer Research, a journal of the American Association for Cancer Research. Yes, that is an impressive title for a  very impressive woman! Dr. Knudsen oversees all aspects of cancer research and cancer patient care at all 13 SKCC sites within the Greater Philadelphia region. Under Dr. Knudsen’s leadership, SKCC is consistently ranked as one of the top hospitals for cancer care in the nation by US News & World Report. Dr. Knudsen also serves as Chair of the Department of Cancer Biology at the Thomas Jefferson University, and holds joint appointments in the departments of Urology, Medical Oncology, and Radiation Oncology. Dr. Knudsen’s expertise is in developing new means to treat advanced cancers, and her laboratory is genetic alterations that contribute to disease progression. Dr. Knudsen is highly active in the cancer field, serving as the Editor-in-Chief of the AACR journal Molecular Cancer Research, as a member of multiple national and international review panels including the NCI Parent Committee, holds leadership roles in national organizations including ASCO and AACR, and is Chair-Elect for both ASCO-GU and AACI.

Edith Peterson Mitchell, MD, FACP, FCCP, is board certified in internal medicine and medical oncology and is clinical professor, Department of Medicine and Medical Oncology, at Sidney Kimmel Medical College at Thomas Jefferson University and associate director for diversity programs and director of the Center to Eliminate Cancer Disparities for the Sidney Kimmel Cancer Center at Thomas Jefferson University. Dr. Mitchell's research in breast, colorectal, and pancreatic cancers and other GI malignancies involves new drug evaluation and chemotherapy, development of new therapeutic regimens, chemoradiation strategies for combined modality therapy, patient selection criteria, and supportive care for patients with gastrointestinal cancer. She has spent her medical career assisting individuals in medically underserved areas realize that changes in lifestyle can dramatically impact cancer care. Through her work, Dr. Mitchell has demonstrated the importance of community service and outreach, especially to individuals unable to obtain more conventional medical advice. Dr. Mitchell holds leadership positions in the American Society of Clinical Oncology (ASCO), serves on the National Cancer Institute (NCI) Review Panel, the Cancer Investigations Review Committee, the Clinical Trials and Translational Research Advisory Committee, and the National Institutes of Health (NIH) Council of Councils; is co-chair of the NCI Disparities Committee; and served on the NCI's Blue Ribbon Panel. She was the 116th president of the National Medical Association. Dr. Mitchell is also a retired United States Air Force Brigadier General, having served in the Air National Guard. You can learn more by going to joinallofus.org, or visit their Twitter profile @allofusresearch, #joinallofus. 01:40 What All of Us is. 01:50 Learning about and understanding disease processes through precision medicine to create the largest, richest biomedical data set ever. 02:40 Why All of Us calls individuals participants, not patients. 03:25 Where the data for All of Us are coming from. 06:00 How All of Us can utilize data to pinpoint health issues in specific geographies. 07:20 How health systems can utilize geography-specific data to anticipate greater health population needs. 9:50 Is your ZIP code more important than your genetic code for certain disease processes? 10:30 Data sets vs studies. 12:50 Demographic data vs outcomes data, and what types of data All of Us is collecting. 13:55 How these data sets All of Us is collecting can benefit anyone interested in research and/or clinical trials. 16:00 Biobank vs data sets. 17:05 How Dr. Mitchell sees All of Us as enhancing and facilitating research. 22:20 The opportunities All of Us presents through its data sets. 24:00 Making medicine more individualized through All of Us. 26:15 You can learn more by going to joinallofus.org, or visit their Twitter profile @allofusresearch, #joinallofus.

Kris LeFebvre, MSN, RN, AOCN®, oncology clinical specialist at ONS talks with Michele Gaguski, MSN, RN, AOCN®, CHPN, NE-BC, APN-C, cancer services administrator at the Sidney Kimmel Cancer Center about the importance of nursing competencies, certification, and obtaining chemo cards for practice. Learn more about how you can elevate your oncology practice. More Resources: ONS Education Position Statement ASCO/ONS Chemotherapy Administration Safety Standards Oncology Certification for Nurses Oncology Nursing Certification Corporation For more oncology nursing information and resources, visit www.ons.org. Music Credit: "Fireflies and Stardust" Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0/

Dr. Josh Lauring, Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at John's Hopkins, presents the joint ASCO/AMP Guideline on Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in cancer, published in the Journal of Molecular Pathology in January 2017.

In recognition of Breast Cancer Awareness Month, Mr. Byron Sogie-Thomas, Deputy Director for Health Policy Research & Analysis at the Health Policy Research Consortium, and Dr. Edith Mitchell, Professor of Medical Oncology at the Sidney Kimmel Cancer Center and past President of the National Medical Association shared their knowledge about breast cancer.