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Sapna P. Patel, MD: Hello. I'm Dr Sapna Patel. Welcome to Medscape's InDiscussion series on melanoma. This is episode number six. Today, we'll be discussing the management of melanoma in community oncology practice. First, let me introduce my guests. We have Dr Craig Devoe, associate professor at Zucker School of Medicine at Hofstra/Northwell and chief of the division of hematology and medical oncology at Zuckerberg Cancer Center. We also have Dr Paul Wright, assistant professor at Michigan State and medical director at Corewell Health West Cancer Center. Welcome to InDiscussion. This is the first duo that we're having, so for the listeners, I'll certainly try to clarify who I'm directing the question to and who's answering. We've been starting with icebreakers to tell the listeners something about yourselves that many people may not know. Paul, we'll start with you.
G. Paul Wright, MD: One thing that's interesting about me is that I'm a surgical oncologist by day, but I'm also an army reservist and have spent some time overseas on a couple of combat deployments. I've been to Afghanistan and most recently spent 4 months of this year in Somalia doing noncancer surgery. It was a different exposure than my prior surgical training but definitely a unique aspect that most surgical oncologists don't see.
Patel: I'm in awe of that. I'm so appreciative for people who give their time. How much time per year does it take being in the Reserve?
Wright: One weekend a month, 2 weeks a year is the typical reserve schedule. But it's been about 3 years between my deployments, and I usually go for 3-4 months at a time.
Patel: Wow. Incredible. Craig, how about you?
Craig Devoe, MD, MS: I think I should have gone first because it's hard to follow that. I want to thank Paul for his service to our country. All I can say I'm focused on right now is the college search for my daughter who is 17. I know it's not exactly what's interesting about me. But my focus has been on traveling around in the Northeast region enjoying time with my family, exploring colleges, reminiscing about being an undergraduate, and remembering my decision to go to medical school when I was at Cornell. I was an engineer and transitioned into health sciences my junior year. In any event, I'm excited to be here today, and I appreciate the opportunity to speak on this terrific trial.
Patel: That's great to be able to look at college with a new set of lenses. We're here to talk about oncology in community practices, and you guys are at some real powerhouses in the state of New York and in the state of Michigan — really large catchment areas for the cancer population. Can you both describe the catchment area for your cancer center and perhaps your practice? We can start with you, Craig.
Devoe: First of all, Northwell Health is a health system. It's not just a hospital. It's around 22 hospitals or so, and counting. The power of the system is just that. It's a very broad catchment area. One of the ways I was successful in this study and look forward to being successful in the future was by opening multiple sites across Long Island, lower New York State, and Staten Island. We're now in Manhattan, as well.
Patel: That's very powerful. That means that your footprint really is quite broad, and then you have a pretty diverse patient population, which has led you to form a pretty diverse trial portfolio and treatment options for patients.
Devoe: Absolutely.
Patel: Paul, I know it's undergone a number of affiliations and name changes, but where you practice in Michigan was the highest-enrolling site in SWOG S1801. SWOG S1801 was a randomized phase 2 study of neoadjuvant-adjuvant pembrolizumab compared to the standard of care, surgical resection followed by adjuvant-only pembrolizumab. And the trial had a statistically significant improved finding for the neoadjuvant-adjuvant group in event-free survival. So, this was fewer events, which were defined as early issues, not making it to surgery because of disease progression, not making it to surgery because of toxicity, melanoma progression immediately after surgery — so not able to start adjuvant therapy, and that could happen in either arm — or melanoma recurrence or death at any time. Event-free survival is one of these endpoints we look at in neoadjuvant therapy, but what we really found was the impressive uptake of this study. Maybe what was more impressive was that the enrollment was not just strong at academic centers but at community oncology practices. Paul, you had the number one enrollment site. You guys enrolled over 30 patients in this 300-patient study. And you single-handedly did maybe 36 surgeries in this study. You were by far the busiest surgeon. Certainly, there was some interest in this study, but I wonder, for where you practice, tell me about the patient pool you guys draw from. Is it pretty specific to certain mileage from your institute, or are you drawing across the region, as well? Was having this trial an important pull for patients across the area?
Wright: We are definitely drawing from across the region. We have a similar setup to what Craig described. There's a main campus and lots of satellite hospitals. We have an extension of our cancer center. That's about an hour north of us, and it reaches a more rural population.
Patel: I think both of your institutions are part of the US NCORP, which is the National Community Oncology Research Program. So just by way of background, the structure of the NCTN, or National Clinical Trials Network, has five US network groups, and then it also includes the Canadian Collaborating Clinical Trials Network. The membership of these NCTN groups is really based on criteria specific for each. So it's SWOG or Southwest Oncology Group — although we haven't been called that for a long time — it's the SWOG Cancer Research Network, ECOG-ACRIN, NRG Oncology Alliance, and then the Children's Oncology Group, COG. So membership in at least one group allows you to participate in any of the trials these organizations might open. So consequently, you often have lead academic partnering sites where these ideas originate or that have the deep infrastructure to run these trials. But you also have enrollment at Community Oncology Research Programs, NCORPs, where you guys are practicing. Other academic centers, practices, and international sites can join these trials. SWOG S1404 before S1801 was an international trial in Ireland, Canada, and the United States, and there were 32 lead academic partnering institutions and I think just as many NCORP sites. Being part of NCORP really allows a site to reach into the NCTN portfolio for any type of cancer — gastrointestinal cancer, sarcoma, hematologic malignancies, and in this case, melanoma — and see if there is a trial of interest. Craig, how do you guys keep up with the NCTN portfolio? Is somebody at the main cancer center essentially in charge of NCTN, or is it an institutional principal investigator? Are you combing those trials and, if there is a good one, distilling it over to your satellite sites so they might enroll patients?
Devoe: That's a lot to think through. We've been an NCORP site, and we've had our grant for roughly over 40 years. That started before I came. We were very established in the Cancer and Leukemia Group B (CALGB) and especially the leukemia program and the breast program, which was the National Surgical Adjuvant Breast and Bowel Project. There has been merging of some of these groups over time, but we're also members of the NRG, now Alliance, formerly CALGB, and SWOG. I'm not sure if we were members of SWOG at the time when I found this trial. Slightly tangential to your question, when I was a part of the NRG Oncology/Alliance, the melanoma group closed. There were so many negative trials, so I started combing through the NCTN to look for studies at ECOG and SWOG over time. I had a couple of the ECOG trials open with interferon, etc., over the years. In any event, currently we have disease management teams for gastrointestinal cancer, cutaneous cancer, etc., and we're now forming research champions for each of those groups who will canvas the site and look for trials that make sense. We also have a cancer clinical trials office that oversees our operations, administrator, managers, and directors. But we're constantly looking at the cooperative group to support our NCORP grant and looking at pharma and where we can develop investigator-initiated trials, as well. This has been a great structure for us to be able to access these kinds of trials. It was one of my talking points today, so I'm so glad you brought up the NCORP because we're very fortunate to have had it. It's been a great platform to bring trials to the community, as you say.
Patel: One of the things I think is beneficial is that there's an online deposit box for all of these trials where you can click through and sort by disease type or cooperative group if you only want to look at NRG or SWOG trials. The protocol is sitting there, and the consent form is sitting there, and also the coverage determination, so you can see whether it is going to be a dog, financially, as it often is for these NCTN trials. They really are not moneymakers. So many of us have to adjust our portfolio to have some pharma trials and then balance it out with some of these NCTN trials. But I love the idea that it's all sitting there because with the pharma trial, if you're not a chosen site, you really don't have access to that protocol document. You are really struggling to find some online version of the schema so you even know what's happening. But here, with the process you guys have at Northwell, Craig, it sounds like there's a pretty routine combing through the big NCTN portfolio. Paul, I wonder for somebody like you — I know it's early in your career still — but are clinical trials something nice to have? You're staying pretty busy clinically, so are you the one who's combing and looking for these? Or is it your medical oncologist who's saying, "Hey, I know you want to operate, but we've got access to this trial." How's it working for you in Michigan?
Wright: It's a little bit of both. We certainly have a great NCORP as well that has been long standing, and the staff there are phenomenal. We couldn't enroll like we have without people who are on the front lines helping out. So really, it's kudos to them and a testament to their work to do this especially through a pandemic, and then continue to keep it rolling, which is impressive. They're combing through, and certainly if there's something I haven't seen, letting me know, "Hey, this involves a surgical aspect." They know I'm a champion for trials and trying to get them moved through. There's a multidisciplinary aspect to this where you have to have both sides, surgery and medical oncology, interested in being involved to be really successful and a high enroller. Then, through the NCORP, I've also taken advantage of attending the SWOG and ECOG meetings. I try to do those at least once a year. I get the lay of the land of what's upcoming. Sometimes I'll see a trial that's about to activate and say, "Hey, you there in the NCORP, just so you know, when you see this come through, please let me know because we really want to get it going." We did that recently with the MelMarT trial, which is a melanoma margins trial that's open through SWOG and others. This allowed us to get it open very quickly and get patients in, and we've been successful with that trial, as well. So it's a little mixture of both. What's interesting on the industry side is that my medical oncology colleague, Dr Yuanbin Chen, who participates with me a lot in these trials, has now been able to leverage this toward a favorable selection for industry trials. It's worked out well for all parties.
Patel: I agree, and that's why I feel so strongly about highlighting the participation of NCORP in these SWOG trials. The patients are there, they're in the community, and they're not having to go terribly far. Of course, some might drive a couple of hours across Michigan to get care, but they're not necessarily having to board a plane and leave the state. And the quality of the enrollments are great. We're seeing great data management. We're having great entry and participation. Like you said, that then puts certain sites on the radar for industry-sponsored trials to say, "Look, these places did a great job on the cooperative group sites, so why don't you give them a shot at some of the industry-sponsored trials?" I now have a couple of talking points. I want to talk about participation in the cooperative groups just as a member, but before we get there, one of the things about neoadjuvant trials that you said, Paul, is that they are very multidisciplinary. It's not that one person can make the decision, "Hey, I'm going to give medical therapy and the surgeon's going to have to put a pause on things." You have to communicate that together. So as neoadjuvant trials are being developed in the academic melanoma space over the last decade, there was this soft mandate that we needed to have a multidisciplinary meeting documented in the patient's chart saying that everybody's agreeing — this surgeon, this medical oncologist, these surgeons. And when we wrote S1801, I thought, that's not possible. We can't mandate multidisciplinary notes, and I'm not going to comb through and make sure what did or didn't happen. Let's just see how the chips fall. Let's see if sites really get themselves tangled up by not communicating with their multidisciplinary groups. Tell me how it works in Michigan and where you're practicing, Paul. You've got all these sites, and you practice at one main campus. Presumably, are you having tumor boards? Do you have access to tumor boards, or is it the old-fashioned pick up the phone and talk to the referring physician and chat with them about what to do for this particular case?
Wright: We do have a cutaneous oncology tumor board that has great participation and involvement. But the decision-making for these sometimes has to happen relatively quickly. So it does boil down to communication, as most things do, and being able to make that happen. Each institution is different in terms of where the bottleneck is for referrals. Do they go in through the surgeons? Do they go through medical oncology? There's some significant variability there. Here it happens to go through surgery. Most of these cases we saw in S1801 were coming to me first, so it was incumbent on me to have some of that medical oncology discussion to frame that for the patients. But again, with a practical study like S1801, the discussion was pretty easy. There was not a long delay to surgery. So I really wasn't worried about people progressing in that neoadjuvant interval, and at the end of the day, patients were getting the same treatment. They were all getting surgery. They're all getting the 17 or 18 cycles of pembrolizumab. It was relatively easy to explain to them that they're getting the same care, essentially. Really, it was just a timing test, so the more simplified the design and the more pragmatic, the easier it is to enroll, and that was a definite strong suit of S1801 for us.
Patel: You said a buzzword there, "pragmatic." Craig, how about you? Do you have tumor boards, or are you just making sure you quarterback each case for the patient?
Devoe: It's interesting. You're hearing Dr Wright as a surgeon. I'm a medical oncologist. I had to pull the cases in. Acting as a site principal investigator, I had to reach out to the surgeons. And yes, I know the melanoma surgeons. I've been working with them for years, obviously. But it was more of an education and a change in process to get the patients to come to me before the surgeons operated. That's something surgeons typically like to hear about. So it took a while for us to change that thinking and the process to get the patient sent over. After one or two surgeons saw those pathological complete remissions, they were hooked, but creating the team was critical.
We have education, the championing of the trial through COVID, and then reestablishing it, by the way. But we have a mixture — we do have cutaneous tumor boards, but a lot of the surgeons in them at a place this size at different sites aren't attending them even virtually because everybody has different operating room schedules. So it was really just being a champion and educating on the biologic plausibility of the trial, and then people implementing it, seeing some successes, and being excited by the trial grew on itself and it snowballed from there.
Patel: Success will always beget success. You're practicing in the real world where having a structured tumor board is nice on paper, but it doesn't actually happen. That's not how we take care of the majority of our patients. They don't all get presented at a multidisciplinary tumor board, and once there's a new standard established, you may need it even less. If somebody is listening and they're not sure why they would participate in NCTN or open trials, as I alluded to earlier, they are financial dogs, right? They pull down your portfolio because you're not making money on them. You barely have enough funding to support the staff to run them and if you don't, you're pulling from other funding. So you're losing money opening these trials. Because of the strong enrollment of both Northwell and Spectrum Health, and in Michigan where you are, Paul, we put you on the top abstracts for these. Then we were able to include you in The New England Journal of Medicine publication. Now, at an academic site, that publication, that's your currency. That's how you get promoted and get tenure and other things. Is that important for NCORPs? Is that important for you guys? Or what was the draw? We love to reward people who are doing the work with something, and because we can't do it financially, we think academic credibility is something we can give. Craig, I'm curious, what do you feel is the biggest thing you got out of S1801? Of course, it's great for the patients, but is there anything that the NCTN can do to show appreciation or help engage when the trials are difficult financially to open?
Devoe: Certainly, you get bragging rights. Your dean and your chair are thrilled by a publication in The New England Journal of Medicine that comes out of a trial. I don't know if it's a marketing perspective, but certainly at least internal marketing — it's not something you send out to patients — but internally, there's congratulations and fanfare over this publication. It's the culmination of several years of work that led to this publication. And of course it was a very good publication and it was an excellent outcome. So yes, it is important. We do have a medical school. We do have promotions. I'm an associate professor. Without publications, I stay as an assistant professor. There's no growth academically. Personally and professionally, I want to bring something to the table even though I'm not at an National Cancer Institute–designated center. It gives me the ability to bring something to the table to offer to patients and feel professionally satisfied. That's why I'm here. Clinical research allows us to do something more.
Patel: I like that. We certainly had more classical practice models. Obviously, NCORPs are going to be some hybrid of being in practice where the majority of these patients are and having a clinical research stakehold — really putting your name on that. But I know some of the NCORP sites that enrolled don't have that assistant/associate professor sort of model. They have "director of this," and you're a staff member. So it's good to hear that with the awareness and success of a trial — and by the way, negative trials should be considered successful for completing, asking, and answering a question — what I saw happen subtly was that each of these places got to have their bragging rights, like you said. They said they participated in a trial and saw its conclusion, and I could see these little press releases coming out in people's communities. Those are really great to see, and I hope that we do reward our high-enrolling sites, which are the real boots on the ground. I hope we're rewarding them in a way that feels meaningful. Certainly publications are great, but also important is the internal fanfare and acknowledgement through your hospital system through the state of Michigan saying, "Look, we participated in something that might be changing the needle for patients." Paul, does this resonate with you?
Wright: One hundred percent. Obviously, there's personal pride and bragging rights, which resonate with me for certain. I'm a competitive guy overall, and that was a big driver. But we certainly have benefited from it in terms of our cancer center. We sent out a cutaneous oncology update for our results for 2022, and we actually got reprints of The New England Journal of Medicine article to sign in order to show the stuff we're doing and offering. We sent this to all of our dermatology colleagues in the community, which are a large part of our referral base, and I think we're reaping rewards from this. There's not a column on the spreadsheet that shows this. That's one of the challenges — these are the kinds of things that bring people in, but it's sometimes hard to show it directly. We're always using this to make the argument for more support and funding and those kinds of things.
Patel: The next step for S1801 is obviously to look at the tissue and the pathologic response in the neoadjuvant patients. You guys have gotten to see a little bit of embargoed confidential data that we will hopefully be able to share in a few short weeks with the general public. But if we do another version of this, and even if it's not a podcast, I would love to sit down with you guys again once I have the ability to go through site by site. It would be pretty cool to look at Northwell and then the Michigan pathologic response. Meaning, we talked about how multidisciplinary care is crucial for neoadjuvant patients. You, the surgeon and the medical oncologist have to talk, but there's an entire other communication that has to happen. The surgeon must talk to the pathologist and have some communication of, "Hey, pathologist, this was a neoadjuvant case." Or, "Hey, grossing technician, you actually have to section this tissue differently," and write it out in the protocol in a checklist that ideally is printed and posted in the grossing room. It probably didn't happen. We can imagine that things aren't followed perfectly in the real world. But without that communication, a lot of these gross nodal-positive specimens will be bivalved. The technician will basically halve the tissue, and then the pathologist will measure the largest specimen or the largest deposit. That's not what we needed in S1801. We needed this thin sectioning, almost like a sentinel lymph node, so the pathologist could go slice by slice and add up necrosis, fibrosis, melanophages, or pigment and then viable tumor. That is going to increase the time it takes a pathologist to read this. So they're going to go from reading gross nodal disease very quickly to now being slowed down. It's probably going to take them 10 times as long to read if done the way we're saying. I'd love to sit down with you guys at some point and say, "It looks like we missed the mark. We didn't get the specimens grossed this way." Was it a miss in communication from surgeon to pathologist? Do we think the pathologist said, "This is nice to do, but I'm not getting reimbursed for my time to do this extra work here." Or ultimately, does it even matter? Are outcomes driven by complete pathologic response? Do you have outcomes of either complete disappearance of the tumor or anything less than that? Is it just that dichotomous, or are these gradations of pathologic response important and a near pathologic complete response gets you better outcomes than a partial gets you, and so forth? We need to figure out where the parsing is, so that we make it real-world accessible for practices, surgeons, pathologists, and then the interpreting medical oncologists who have to decide what to do in the adjuvant setting, perhaps based on that information. So that's a lot. That was probably more of a statement than a question. Maybe at some point we can think about this. Paul, I don't know how you communicated with your pathologist or if you even know — did they post the S1801 grossing instructions? I have not even looked site by site to know how good the Michigan group was at this, but I suspect this is another area of communication that has to be refined.
Wright: I'm curious. I would love to know how we did. I don't honestly know. We have a great dermatopathologist who is very thorough, so I suspect they probably did pretty well. But there's also that layer of grossing that probably happens before it even gets to her, and you how well that was followed, so I'm not sure. There's definitely some logistical challenges with the more parties that are involved, that's for sure.
Patel: We've noticed that, obviously, if the surgeon forgets to tell the pathology team that this was neoadjuvant therapy, they're going to do regular bivalving like it was a gross nodal positivity. The last thing I wanted to ask is, since you guys have had this participation and really successful effort with S1801, there are more trials to come, and our portfolio is growing like you were saying, Paul. MelMarT is a surgical trial for stage 2 disease that we are currently enrolling for successfully, and SWOG is leading the world for enrollment. You guys both know that I've been trying to draw you into the SWOG committees. Most of these NCTNs will have surgical oncology committees, which is another place for a touch point to see what they have access to across disease sites. Craig, maybe just make a comment or two on what you think about participation in SWOG committee meetings, participation in the group meetings, and what this might mean as far as having a closer access to trials, the investigators, or being able to bring an idea forward. Is this something that is helpful for you? Or, is it more helpful for the lead academic sites to do the heavy lifting coming up with the ideas, and you're happy to comb through and turn on the switch for the ones that work for you?
Devoe: It's all of that right now, Sapna, certainly in terms of hearing about the process of trial development and the discussions. And there are a lot of tradeoffs as these things are developed over time, and then the bringing in of fresh ideas and point and counterpoint discussions. I do hope to bring something forward, as well. Again, it also depends on your site and the research protected time you might get to develop in those areas. As we grow our program and we look at the finances of all this, at least in cutaneous disease, we'll definitely have more input as opposed to just listening.
Patel: It's been great to see you on the last several months' worth of melanoma committee calls. So, thanks for that. Paul, you mentioned you like to try to attend the ECOG-ACRIN and SWOG group meetings at least once a year. And of course, as a surgeon, your schedule probably isn't as flexible for things like standing calls, but, is there any other type of participation you are looking forward to in these group meetings? There's grant funding through these. There's often support to travel to meetings and things like that. Is there anything else that is exciting for you working through the NCTN?
Wright: Certainly, participation in committees is exciting and the chance to get in a group of people with differing perspectives and viewpoints. I think we, on the NCORP side, have a different perspective in terms of the practicality of how things get out into the community and so forth. That's a good perspective that probably needs to be a part of those committees. And just the same, a surgical voice is helpful. I talk about that a lot with patients — that we view things through different lenses, neither good nor bad but just different lenses in terms of our approach to patients. Having those discussions among disciplines is helpful. I look forward to continuing to be involved in that. Ultimately, it's about bringing those options to our patients. One thing that I've learned — I'm still young in my seventh year of practice here — is learning how to talk to patients about randomized trials and enrollment. I always tell them the goal is that they're getting in on the ground floor of the next big thing. S1801 is a perfect example. Some people were nervous about not going to surgery right away because that was the standard. But in the end, the patients as a group benefited overall, and it has essentially become the new standard of care. There's so much benefit to trial involvement for patients. As many as we can get in a trial as possible is my career goal. Every patient in a trial would be ideal world.
Patel: I'll close with a story. I have been involved with SWOG for a long time, probably since 2011 or 2012. My mentor has turned into my dear friend. Kevin Kim was at MD Anderson at the time and said, "Why don't you come with me to this SWOG meeting?" I attended and sat there very quietly, as a junior faculty member, and then I went to the next one 6 months later. I'm a closet introvert who knows how to put on my extrovert self in certain situations when talking to a patient or giving a medical talk, but my introvert self sat at these meetings quietly and listened and heard really high-level conversation. Eventually, there might be a discussion I wanted to contribute to. But even without necessarily being a dominant participant or voice at those committee meetings, I got a lot out of them. Of course, I was at a high-volume center, so that got noticed, and then Tony Ribas approached me and asked if I could you help run S1404. When we did so well with that, they said, "Why don't you take the reins on the next trial?" It was a slow burn and quiet participation. But that's some of the benefit of this process. Committee involvement can be a safe place to help nurture and foster development of what comes next either at your institution or for you personally.
Let me wrap up here by saying that I'm so grateful to you, Craig, and Paul for joining me today. What we talked about was the idea of practicing oncology where these patients really exist, which is in the community practices and at NCORP sites. We also talked about what participation in the NCTN looks like, where you draw your patients from, how you think about your clinical trials portfolio, and some of the benefits of participating in these NCTN trials. Thank you all for listening and tuning in. If you haven't already done so, please take a moment to download the Medscape mobile app to listen and subscribe to this podcast series on melanoma. This is Dr Sapna Patel for InDiscussion.
Resources
Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma
National Cancer Institute Community Oncology Research Program (NCORP)
ECOG-ACRIN Cancer Research Group
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Cite this: The Management of Melanoma in Community Oncology Practice - Medscape - Oct 18, 2023.
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