JCO PO author Dr. Jens Rueter Chief Medical Officer at The Jackson Laboratory and Medical Director of the Maine Cancer Genomics Initiative, shares insights into his JCO PO article, “The Maine Cancer Genomics Initiative: Implementing a Community Cancer Genomics Program Across an Entire Rural State.” Host Dr. Rafeh Naqash and Dr. Rueter discuss this successful initiative for patients and its implementation for access to precision oncology in rural settings.

TRANSCRIPT

Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, Social Media Editor for JCO Precision Oncology, and Assistant Professor at the OU Stephenson Cancer Center. Today we are joined by Dr. Jens Rueter, Chief Medical Officer at The Jackson Laboratory and Medical Director at the Maine Cancer Genomics Initiative. Dr. Rueter is also the Associate Director for Regional Translational Partnerships at the Jackson Cancer Center and the lead author of the JCO Precision Oncology article titled “The Maine Cancer Genomics Initiative: Implementing a Community Cancer Genomics Program Across an Entire Rural State.”

Full disclosures for our guest will be linked in the transcript and can be found on the article's publication page.

Welcome to our podcast and thank you for joining us today, Dr. Rueter.

Dr. Jens Rueter: Well, thanks for having me. It's a pleasure to be here.

Dr. Rafeh Naqash: For the sake of this podcast, we'll refer to each other using our first name if that's okay with you.

Dr. Jens Rueter: That's great.

Dr. Rafeh Naqash: So this article that your group published in JCO Precision Oncology has significant implications. It has broad outreach. It incorporates an aspect of Precision Oncology that is very important for not only academia but also from a community outreach perspective, which is one of the reasons why I chose this as one of our podcast highlights. So to start off, I would really be interested to know what are the current barriers to the implementation of Precision Oncology, especially in rural settings versus urban settings, that can impact cancer mortality.

Dr. Jens Rueter: Yeah, that's a great question. Let me just go back a little bit in time here. When we first started with the Maine Cancer Genomics Initiative back in 2016, the problems were actually even more significant than they are today. Back in those days, I would say even access to testing was a problem in rural areas. And I think that is still the first thing to consider when thinking about barriers. Back in 2016, there were only a handful of testing companies. There were issues with reimbursement or patient out-of-pocket costs. So I think that's the first barrier. I would say that that has significantly changed in the last six years. There are more testing companies available. It appears that the out-of-pocket expenses for patients have dramatically decreased or the systems programs have improved. There are still some barriers, but I think it's a much smaller part of the population.

The second barrier to implementation, though, which remains to this day, and in fact, I would argue has actually become more complicated, is a quick and comprehensive, yet fast and deliverable interpretation of the test reports. The test reports contain a lot of information. It's often 20 to 30 pages long, multiple sections, and really understanding how to utilize that information for clinical care is a very significant issue for clinicians to this day. So that's the second barrier.

And I think then the third barrier that is still ongoing and I think, especially in rural areas, is the access to treatments through either a clinical trial or even through off-label prescriptions, that both of those require a lot of infrastructure, and that still remains a significant issue to this day.

Dr. Rafeh Naqash: You touched up on some very important aspects and one being understanding of genomic reports and this has been something that I talk to fellows all the know. I finished fellowship a few years back. At that time, NGS testing was becoming more and more prevalent, even though, as you mentioned in your paper, CMS coverage for this didn't start until 2018, 2019 approximately. And from a phase one trial standpoint, which is what I do, I have probably a little more exposure to genomics and precision medicine than perhaps some of our community colleagues. But it does come up often when we get referrals from outside sites. We're trying to look through the report and see something that stands out, whether it's a varying allele frequency that's high enough to warrant testing, germline testing, or some other targets that were identified a few years back but probably were not acted upon.

So you had this very interesting approach, a three-pronged approach is what I understood, of how you tried to tackle this within your main precision oncology program. Before we go there, could you tell us what was the idea behind establishing something like this? Because I imagine bringing it to fruition is something much more complicated, but the idea is where it starts. So I imagine, like, you probably had a conversation with some of your colleagues or somebody else noticed this as a barrier in the clinic and came up with this sort of an approach. Could you touch upon that for the sake of our listeners?

Dr. Jens Rueter: Yes. So back in 2016, or actually in 2015, when we started conceptualizing the Maine Cancer Genomics Initiative, the idea was to look at Maine as a state, as a very rural state. The Jackson Laboratory is an NCI-designated basic science cancer center in the state, the only NCI-designated cancer center in the state. And we feel like there is an obligation, if you will, to the state to do good for all of Maine. So it's a community approach that we felt was important. And we realized then at the time that, again, that testing genomic tumor testing, or NGS testing while available, was not being used effectively in the community. So I think those two ideas essentially made us think and believe that we should take the lead in starting such a program.

We felt that we had actually one significant advantage in that we are a non-patient care organization. So the Jackson Laboratory, even though we have an NCI-designated cancer center, we don't see patients at Jax. So we were not a competitor, if you will, for patients in the state. So we were an honest broker. We were sort of a neutral Switzerland, if you will, in Maine, and were able to convene the entire community around this concept. Even though Maine is a small state, there are a number of healthcare systems that are actually competing with each other for patients in certain areas. And when we sort of started this program, we said, look, we want to work with everyone, and it's important for us to work with everyone, and we want to include even the smaller, truly rural critical access hospitals that have small, very small oncology practices. They're just as important to us as the larger centers. So I think that was sort of the community idea behind this and this is what really started it all. And then also, again, the fact that testing was such an issue, it also happened that at the time, Jax had just started we had just started our own clinical laboratory, our own CLIA certified laboratory. So we felt like we actually had the expertise to bring a test to the community that would then engage them to utilize the technology more effectively. And that's how we proceeded with this.

Dr. Rafeh Naqash: Excellent. And I totally agree that this inclusive stakeholder approach that you had was probably one of the elements for success in this kind of an approach and led to a significant impact in the lives of patients. You mentioned three things that you targeted or three things that you identified and tried to implement as part of this Precision Oncology program. Could you tell us about those briefly, what they were, and why they were important to be included in this approach?

Dr. Jens Rueter: Yes, absolutely. So the first and most important one and most impactful one was that we developed a genomic tumor board program through this initiative, which again we had a centralized yet hub-and-spoke type approach where we said, “Okay, we are going to organize these for all of the practices, for all of the studies. The patients that are enrolled in our study protocol, we will organize these and basically create an environment where we call on national experts from around the country and, in fact, around the world at this point, that call in and provide input on the different cases that the physicians had enrolled.” We left it up to the physicians to decide which cases they wanted to present because they had some patients that they enrolled where they felt like they didn't necessarily have to present the case. So there was a lot of buy-in for these genomic tumor boards because we really discussed cases that were probably the most challenging ones and the most relevant ones.

So I think the genomic tumor board program was really the most significant development and the most significant infrastructure that we built. And in fact, the work that we did in Maine actually enabled us to design a cluster randomized study that we're now running through the SWOG Cancer Research Network. I'm leading that effort with a collaborator from Columbia in New York, actually, Meghna Trivedi. And so that was really a great success, and we will hopefully in a few years know if this approach actually leads to changes in some patient outcomes. We have some indication that it does from our own work, but we will see that in a more rigorous fashion.

The second pillar, if you will, the second part of the approach was that we have a dedicated clinical education group at JAX. So JAX Laboratories, as I said, a basic science cancer center, but we also have essentially an entire group dedicated to genomic education. And part of that group is focused on clinical genomics education. So we have a modular online program that clinicians can access, not just the physicians, but also the nurses and other people, other members of the patient care team. And in fact, in addition to the online program, we ran a few virtual educational sessions specifically for nurses, which we actually found was, nurses and clinical research coordinators were really one of the most important keys to success as well, that we get them on board and enable them to better understand the complexities of testing.

And then the third aspect, of course, was that we did provide the testing as well as part of this initiative, which we saw as kind of a method to really engage clinicians and take the pressure off the clinicians. “What if I order this testing? Are patients going to come back with significant out-of-pocket expenses?” Again, that was particularly relevant back in 2016, 2017, before the CMS coverage decision. So those three aspects were really what drove this program.

Dr. Rafeh Naqash: Excellent. Now what I gather is for something like this to come to a full functional state, you need a team and you need funding. So how did you define or identify the core group of people that were most important for this initiative? And what was the funding source? Because these days, nothing gets done without the appropriate level of funding. So I wanted to ask you and see how you manage some of those logistical issues.

Dr. Jens Rueter: Great question. So this whole program was really enabled by a large philanthropic grant, or donation, if you will, from a foundation called the Harold Alfond Foundation. It's a very large philanthropic organization in New England, and they're very Maine-focused. They have historical or family ties actually to Maine, and it's very important to them to bring Maine sort of to the forefront, sort of out of the rural disadvantage, and turn that into an advantage, which is why they agreed to provide funding for this program. And I agree with you that that is a critical step. This program was always in between a traditional research program that could be funded by an NIH grant, for example. I think that initially you need some startup funding first to get this going, and then later on, as you can develop more concise research questions, I think you can also apply for NIH funding for something like this. But certainly, philanthropy goes a long way here. So that was sort of the funding source, and, I think, very important.

Now, in terms of the team, that's actually a great question. You need a few different functions represented here. So I think, first of all, having some clinical expertise is important. So I was actually specifically hired to JAX for this program. I'm a medical oncologist. I actually still have a small practice in Maine as well, but I was in full practice before I joined JAX. And I was hired specifically for this purpose so I could engage with the community and sort of understand my colleagues over the state. You need a very good and rigorous program manager, someone who can really– It's a complex project that there are many aspects you need to consider and you really need someone that kind of keeps track of all the different activities and makes sure that things are moving in the right direction.

Since we are a research organization, we decided to roll this out on a study protocol. So we hired a clinical research manager that would basically disseminate and enable the study protocol and make sure that it's actually done correctly. Even though it was a low-risk observational study, we still wanted to make sure that we collect good data on the patients and the number of publications that we've been able to produce from this initiative, I think, speak to the quality of the data. And then as the program has evolved, we have actually added on a couple of other key functions within the program, and actually one of them pertains specifically to the genomic tumor boards, which again, I think are really critical to this. So you really need one dedicated person to organize these and coordinate these. It's a lot of scheduling. There's a lot of, as you know, from your own clinical practice, clinicians have very specific schedules, and if you really want to make this successful, you really need to make sure that everyone's schedules are accounted for.

And then we also recently added another function to our program, another individual who is a genomic navigator. Actually, we call it the genomic navigator. And I think that this individual, her job is if there are additional questions, for example, after genomic tumor board, or if there are just some very specific about a test report from the entire- it could be from anyone on the team, the physicians, the nurses, the research coordinators, she can help identify some additional answers to some additional questions. She can also help clinicians if they're interested in finding a clinical trial for the patient or find some supporting evidence for off-label drugs, for example, she can provide them with additional references. We have crafted documents that basically summarize the available evidence that exists for using a specific drug in association with a genomic marker. So I think genomic navigators are also very important, and I think there are some other individuals on my team now, but I think those are the core functions that you really should consider.

Dr. Rafeh Naqash: Thank you for giving us a detailed explanation of the team that I'm pretty sure has expanded over the last few years as you've tried to expand this program concurrently.

Now, going from the team to the platform, I was kind of interested to know a little more about the sequencing platform generally, as from my clinic, I do FoundationOne, or ERUS testing, or Tempus testing, etc., and I'm not very well versed with some of the platforms used. Could you tell us a little bit more about what these platforms are? How big the panels are from a DNA standpoint? And I see you did test for some RNA fusions as well. So could you tell us how that came about?

Dr. Jens Rueter: So when we first started the initiative, we started with a single assay that we ran through the Jackson Laboratory, and it was at the time a fairly contemporary test. It looked at both SNVs, insertions, deletions, and so forth on the DNA level and on copy number variants as well. And it was 212, at the time, 212 cancer-related genes. It was a homegrown panel if you will. This was back in 2017, 2018, and we also had a fusion assay that looked at RNA already at the time. So we were already kind of ahead of the curve at that point because, at the time, many assays were still just looking at DNA for fusion. So we already figured that it would be better to look at the RNA level. And then we sort of grew the panel from there.

The last panel that we used specifically for this first phase of the initiative had grown to 501 genes. It was already done on a specific platform. I think it was one of the Illumina platforms at the time. So we figured the off-the-shelf solutions weren't necessarily the right approach. We also added in tumor mutational burden. We added in MSI. We did not yet have at the time LOH or HRD assessment, but we certainly offered TMB and MSI. And we had the usual sort of commodity testing for PDL-1, which we actually sent out because it wasn't necessarily what we do in-house. So that was during the program as it is described in the manuscript.

I will say we continue this program. We're continuing the genomic tumor boards now. We've never stopped. We just continued after the study was over. We offer it essentially as a service now to the community, as an educational service if you will, and we now actually work with any test reports that the physicians provide. Again, I think the landscape has shifted dramatically and the testing itself doesn't seem to be as much of a barrier anymore. So we look at a lot of Tempus reports, KRAS foundation, every now and then we'll have something that's a little bit more unique, I would say.

There are obviously many other sequencing companies out there and we've actually found that this is– For our genomic tumor boards, we actually developed a template that is non-branded, that is just trying to put every test into the same table, front table, which I think has actually been very helpful for the clinicians because, again, sometimes you just can't find all of the relevant information on the front page. And we comb through every report and try to find every addendum that may have been generated and all kind of collate it in one single slide if you will, so that the clinicians have it right there and then we kind of talk it through as well. So that's essentially the evolution of the testing over the last six, seven years.

Dr. Rafeh Naqash: So this more or less sounds like a very state-of-the-art, contemporary approach that was available more or less to other clinicians at that time. 200 gene panel seems pretty extensive for 2018, 2019 and, as you probably know, things have gone to whole exome at this point, but I think you seem to be doing what was most appropriate at that time.

Now, going to the results between 2017 to 2020, your precision oncology program enrolled around 1600 people. The results were simple but very impactful, is how I describe it. Could you tell us some of the highlights from the results, what you identified, both from an implementation standpoint, participation standpoint, and from an impact at an individual patient's level?

Dr. Jens Rueter: Yeah, I'm happy to do that. So, I think the most important for us, the most important metric was that we were able to, over time, engage all practices and engage all– When we finished with the initiative, at that point, every physician, every oncologist in the state had actually been enrolled in our program as a study participant, which was actually one of the unique features, by the way, of our program: we said we were going to study both the physicians and the clinicians. So we had enrolled on our study 100% of the oncologists. It took us about 18 months to get to all the practices, which I think is an important metric for anyone who wants to pursue something similar. You have to always keep in mind that, even if you come in with a fairly solid proposal and something that is clearly of benefit to patients, every institution that you work with, it's going to take a while before you can get all the agreements signed and the IRB issues settled.

So it took us about 18 months, which I think is still fairly quick actually. And we listed the enrollment as well, the enrollment curve of patients in the paper. And it certainly did take some ramp-up in the very beginning, but then we really very quickly sort of ramped up to a steady state after about a year or so. We discussed about a little bit less than, about a third of the cases actually, at our genomic tumor boards. Almost three-quarters of the physicians actually participated in the genomic tumor boards as well. We ran around 200 GTBs throughout the initiative, and we're currently looking at the clinical outcomes of these patients. It's currently under review what the clinical outcomes were, but I can already say that we are sort of, I would argue, in about the same place in terms of patients that actually went on a genome-match therapy as many other publications in that venue. And it is actually, as you can probably imagine, rather complicated to define what a genome-match therapy actually is. And that will be coming out soon, hopefully soon.

So the other findings are also quite interesting and they have been published in other publications over the last few years. So at baseline, for example, we actually asked the patients, “What are your expectations? What are you expecting from this enrollment, from the tumor testing?” And we actually identified that the patient expectations were very high, which I think is important, an important finding - can be explained partially by precision oncology, it's a buzzword right now, and patients have certainly picked up on this and there are a lot of very high expectations in that it's going to change your outcomes. And physicians also at baseline felt quite confident, actually. There was a fairly good spread, but most of them felt quite confident that they would be able to utilize the information and actually explain it to their patients. They felt mch less confident, very on-point, in my opinion, that they would be able to put the patients on a targeted therapy or that their practice would have the infrastructure to support putting patients on therapy. So those are some of the other findings that we've identified over the last few years overall.

Dr. Rafeh Naqash: Thank you. And just on a side note, I was looking at Figure 4, which shows the number of cases per physician, and one physician particularly stands out with 120+ cases.

Dr. Jens Rueter: Yes.

Dr. Rafeh Naqash: Did that individual physician get any kudos after doing this excellent job?

Dr. Jens Rueter: Yes, actually this physician did. That's actually a really good point that you're bringing up. That's another important finding that I found quite fascinating, actually, that everyone is kind of the same at baseline. We offer the same thing to everyone. And you can see in Figure 4 in the paper that there is a significant spread in terms of how many patients each physician enrolled and also how many they presented at a genomic tumor board. And certainly that one physician is a very engaged member. We have a steering committee that we implemented very early on. That physician is also on our steering committee. And this really has contributed a lot of insights into what has worked well and maybe what hasn't worked so well. So it is a rather fascinating statistic, I agree.

Dr. Rafeh Naqash: One of the things I also noticed from your summary was that the uptake of the genomic testing and being part of this initiative was more for rural areas than for urban areas. And I was trying to understand why perhaps one of the reasons could be that it does help the community physicians in that setting. Was that what you saw, or was there another side to it that perhaps may not necessarily be explained in this manuscript?

Dr. Jens Rueter: Yeah. So, first of all, just to be very clear that the highest enrollment in rural areas was per capita so that’s an important distinction in my opinion. So, it obviously goes that the more rural areas are more densely populated. And what’s actually behind this is that the physicians that were working in those rural areas also just happen to be really engaged in the program and find a lot of value, especially, in the genomic tumor boards. So it was really very much a personable motivation. I would say, though, that the larger issue behind this, or the larger interpretation of these findings is that, especially at that time, I would argue that the– In Maine, you can always see that everything kind of moves from the south all the way to the north. It takes a little bit of time and it’s the same in pretty much anything, but in medicine as well. And so, I think at that time, the NGS testing just wasn’t really used all that much in the more rural areas. So I think the fact that we provided it– And again, there’s also less infrastructure at these smaller hospitals or smaller practices. So running through the hoops of getting prior authorizations and still managing potential out-of-pocket expenses just aren’t there and these were things back in the day for sure that were barriers.

So I think us coming in and saying, “Look, all you have to do is you mention to your patients that there is this program called the Maine Cancer Genomics Initiative, and if you’re interested, someone will contact you from the Jackson Lab and talk to you more about the study and see if you want to participate.” That’s all they needed to do. And then everything else kind of went from there. I think that is really probably one of the reasons why we had such a significant accrual in those more rural areas.

Dr. Rafeh Naqash: Amazing. And one of the things that I am very dreadful of is ‘tissue being the issue’ where, despite the biopsy, despite everything you do, the pathologist comes back. Or you send the tissue to the sequencing company, they come back saying, not enough tumor cells. What were some of the things that you did or your group did to help the people involved in this process understand why tissue matters? Because that can add to further delays in treatment. So I'm very curious to know what some of those things were that you tried to help everybody understand from an educational perspective.

Dr. Jens Rueter: We noticed that very much in the beginning, especially, of the program, so after about two or three months, we realized that there were a significant number of tissue failures and we realized we needed to address that. And we did that both by internal as well as external processes. So we actually looked back at our assay and said, "Look, maybe our requirements for DNA input are just too high. We need to rethink that and maybe there's a way to improve the laboratory processing so that we can actually work with less DNA." So I think that's a very important lesson.

And interestingly enough, I think this is still an issue to this day in a certain way with any of the testing laboratories, and we can get back to that in just a second. But I think the other aspect that was important here was, again, getting on the phone or on a Zoom call or whatever it was at the time, and really talk to the pathologist, talk to the clinicians, talk about, when you order a test, for example, think about beforehand as you're identifying the right specimen. Is this actually potentially enough tissue? If it's an FNA, maybe it's not enough. But if it's a good core biopsy, that's probably the better specimen. So that's certainly on the ordering physician side, but then also on the pathologist side, it was actually quite interesting. And one of the larger pathology practices in the state actually implemented something very smart, I think, as they sign out cases, and I think they do this universally on any case, as a pathologist signs out the case, he will actually indicate on the report which block should be used for sequencing. And they will actually indicate a tumor cell percentage, which I think is an excellent small step, but very impactful because it will reduce frustration on the side of the clinician, if a block is sent with not enough tissue, it will facilitate the workflow between the place where the tissue is stored, for example, and where it's cut, and it makes everything a lot simpler. And I think those are the kinds of things that you really have to think about.

I think in the contemporary times now where it's become quite common for testing companies to weed out samples that have 20% or 30% neoplastic content. What's interesting there, though, is that I feel like sometimes they're almost a little bit optimistic. They're always very clear on the disclosures in the report. They will say that there was a low tumor cell purity and some of the results should be interpreted with caution. But again, I'm not sure that clinicians are actually reading the fine print. So the example has kind of flipped a little bit that nowadays you're getting a lot more information than you did six, seven years ago. But you have to understand better as to how the information was derived.

Dr. Rafeh Naqash: I couldn't agree with you more as far as noting down in the pathology specimen which specimen is the most appropriate for NGS. It's a small thing to do, but I think it makes a huge impact when the research team or the nurses are actually trying to identify what specimen to send.

So now, Jens, coming to the last portion, I'd really like you to summarize in 30 seconds what are the future directions from this program? Where does it stand right now? And what are some of the things that you're trying to add on to the current format?

Dr. Jens Rueter: Where we stand is we're continuing to run our genomic tumor boards in the state of Maine. And as I mentioned earlier, we're also running a national study where we're running an additional GTB per week just to really see how impactful it is on patient outcomes. In the future, we need to improve the processes. We need to streamline the processes with genomic tumor boards, involve more technology to scale it, essentially, and make it more broadly available. And lastly, what's really important is we also need to think more closely about treatment options and enabling rural areas to have more access to clinical trials. And I hope that with the current post-pandemic thinking, that we can actually enable that with technologies, with virtual visits, with virtual consent, and so forth. And then, one other point, we also need to educate patients so that they know what to ask for when they're meeting with the oncologist.

Dr. Rafeh Naqash: Thank you so much.

Now the last portion, a minute or two is going to be dedicated to you specifically. So, Jens, tell us a little bit about your career trajectory. Where did you start? You mentioned earlier that you did or currently do practice clinical oncology. And how did you get into the field of precision medicine that culminated into developing such an impactful program?

Dr. Jens Rueter: We moved to Maine in 2010 after I completed my Hem/Onc Fellowship at the University of Pennsylvania, where I'd actually done quite a lot of translational and bench research. We came to practice. We moved to Bangor, and practiced here. And the Jackson Laboratory is really just on the road from where we are. We're at Mount Desert Island, right next to Acadia National Park, and I started collaborating with some of the scientists. Actually, early on, we built a tissue bank at the Northern Light Hospital here to facilitate translational research. And then when the funding became available, I received a call from the then CEO of Jackson Laboratory, and h, Ed Liu, and he said, "Jens, we're thinking about running this program and would you be interested?" And so that's how I joined JAX. And that's really when I started. I saw at the time already this gap that was widening and I saw how complicated it is to practice rural oncology. And I really saw this as a great opportunity to bring the field forward, to bring Maine forward, and to really address one of the major disparities that still exist to this day.

Prior to that, I spent quite a bit of time doing, as I said, bench research at the University of Pennsylvania. I also did my internal medicine residency at Tulane, and I always thought I was going to be a traditional physician-scientist. I actually feel great about this opportunity because I think it's addressing one of the major issues in contemporary oncology. So that's sort of how I got here. I'm originally from Germany, I went to medical school in Germany, did some research there, and then came to the United States about 20 years ago now for my postgraduate training, and I've stayed here ever since.

Dr. Rafeh Naqash: Excellent. Sounds like you're the right person for this job, with both a clinical translational bench kind of experience and having worked in different settings.

So thank you once again, Jens, for being a part of this conversation. I think at least I learned a lot. Hopefully, our listeners will find it equally interesting, intriguing, and perhaps implement some of the things that you have accomplished as part of this initiative.

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Guest Bio:

Jens Rueter, M.D. is the Chief Medical Officer of The Jackson Laboratory and Medical Director for the Maine Cancer Genomics Initiative.

Guest COIs:

No Disclosures

Implementation of the Maine Cancer Genomics Initiative

JCO Precision Oncology Conversations