Jun 28, 2016
Steven Powell, MD is an Associate Scientist with the Sanford Cancer Biology Center and an Assistant Professor of Internal Medicine at the University of South Dakota Sanford School of Medicine. Sanford Cancer Center is the recipient of the 2016 ICLIO Innovator Award for its process improvement initiative enhancing patient treatment options, to include immunotherapy in the community setting. Dr. Powell will be presenting at the ICLIO National Conference on Sept. 30, 2016 and also on October 21 at the ACCC National Oncology Conference in St. Louis.
The cancer center is part of Sanford Health, an integrated healthcare system that serves predominantly rural communities covering a three-state region. The system includes major cancer centers in Sioux Falls, SD, Fargo, ND, Bismarck, ND, and Bemidji, Minn. Sanford Health sees more than 4,500 cases per year in adult and pediatric oncology.
In 2013, Sanford Health identified cancer immunotherapy as one of the key initiatives for its cancer program. As part of this effort, teams from multiple sites within the health system have adapted programs to deliver immunotherapy to Sanford’s patient population. A driving force within the program’s vision is to improve access to immunotherapy clinical trials at Sanford’s major cancer centers. Dr. Powell recently shared some insights with ICLIO about this process improvement initiative.
Steven Powell, MD: When I joined Sanford about three years ago, there were various disease-specific tumor board programs at each individual cancer center, so we had a really nice infrastructure for local tumor boards. Shortly after I started here, immunotherapy and immuno-oncology were becoming extremely important, as were molecularly targeted therapies.
In my position, I spend half my time conducting research on investigational therapies and biomarkers, so the administration looked to me to help develop our tumor program to include different biomarkers, specifically genomic biomarkers, in an effort to identify patients for matched clinical trial opportunities. When we initially started, the creation of a genomic or molecular tumor board was our main focus. The goal was to try and develop a program to help our physicians interpret genomic testing results. As genomic testing is more widely available through programs like Foundation Medicine and CARIS, we really wanted a way to have a systematic review of this data.
So that’s why we developed our first genomic tumor board. When we started development, we felt that instead of running it at just one of our sites, we should run it through all of Sanford. Our thought was to have something that anybody can call in to, so it ended up becoming a teleconference/video conference tumor board available to all of our partner sites.
Dr. Powell: Fortunately, we had the actual audio-visual equipment and teleconference setup here for years because of the nature of our program. We do have a lot of teleconference meetings due to the large geographic area that we cover. We did not initially have staff to coordinate the genomic tumor board, and we really needed institutional investment for that.
To keep a tumor board like this going, you need to have not only the physicians, but also nursing staff and nurse navigators to triage cases and get background information. Then, actually, it also involved getting a research program. So we employed the help of some of our research program project managers to bring in information on clinical trials and also track data as part of our tumor board. Getting the staff mobilized and working together across all these sites was the biggest challenge.
Dr. Powell: Well, as this kicked off, we developed GEMMA (The Genetic Exploration of the Molecular Basis of Malignancy in Adults), a clinical research program to track the clinical outcomes of many of the patients presented. That was actually funded by the Edith Sanford Breast Cancer Foundation, which is associated with Sanford, but uses donations to improve processes, mainly focused on breast cancer and genomic medicine. So that research program was integral in building the groundwork for the genomic tumor boards.
Dr. Powell: The GEMMA study was originally an observational study and was the foundation for our genomic tumor board. Through that program, 120 patients who consented to have molecular profiling done on their tumors enrolled in the study. Our main goal was to identify treatment options for these patients, either through clinical trials or FDA-approved drugs, and then track outcomes in a structured fashion.
One of our main objectives was to see if we were able to get patients access to the identified drugs. If we were not able to access [the drugs], we identified the barriers to access. If we were able to put a patient on a trial, we also monitored the outcomes for that. There were also a number of patients who were treated with FDA-approved drugs based on the molecular profiling data, oftentimes with immunotherapy agents. We wanted to track outcomes on those patients, as well as unique side effects. So our GEMMA research staff became integrated with our genomic tumor board.
Dr. Powell: Pharmaceutical companies were never directly involved in our tumor board. What happens is we perform an independent review at the conference and when we finish our discussion of each individual patient, the group recommends treatment options. Often these are based on phase 2 or phase 3 clinical trial evidence, or maybe even earlier information that’s emerging from the literature.
When we complete the tumor conference, we send this background to the pharmaceutical company, or even in some cases the insurance company, and say, “We’ve reviewed this case, our team feels that this is the best option for the patient, and here is the data.” It is extremely helpful when you do this background work to provide rationale to the insurer or pharma companies to help them understand the importance for off-label treatment.
In terms of immunotherapy, we’ve had good success both with Merck and their pembrolizumab compound and with Bristol-Myers Squibb and their nivolumab compound when we have ample data to provide them to say, “This is what we feel would be a good option.” Based on this data, they’ve been able to help us get access to drugs for patients.
Dr. Powell: The tumor board is the first step to get that background information and the rationale for the treatment, and then the next step involves our pharmacy team, which reviews the data and submits that for authorization through insurance. If insurance is not able to cover it or is not willing to cover it, then pharmacy contacts the pharmaceutical companies. Our pharmacy team is very important in this process and they actually participate in the tumor boards as well, to hear the rationale for a particular treatment option and gather that data.
Dr. Powell: There’s probably a core group of 25 to 30 people that are in attendance. It’s a mix of physicians, nurse practitioners, and our research staff. For our genomic tumor board, we also have genetic counselors who come to help review the significance of whether or not this could be something that’s a germline issue that could correlate with some syndrome.
Our pharmacy team is there and oftentimes, depending on the conference, radiology and pathology will participate as well. Numbers vary across sites. Sometimes there’s an equal number who are calling in, sometimes it’s just one or two physicians calling. It depends on which site is calling and how many physicians are at that site and what the interest is on the review of the case.
It’s been a very steep learning curve because teleconferences, as you know, sometimes result in delays and can make communication challenging. As we’ve gone through our process, we’ve refined the way that we expect people to present their case. We’ve asked that they pick key points of that case to present, and typically one physician leads that conference.
I typically lead our genomic tumor conference, and there’s a specific format to that. When we review the cases, it’s a very consistent format each time and that’s something that’s had to evolve over the process. We’ve now decided to develop a cancer genomics steering committee to make this run as efficiently as possible and refine our levels of evidence when we present cases.
Dr. Powell: Yes. It is a lot of work, but at the end of the day, I think it’s worth it. As we enter personalized medicine and immunotherapy, I think that it’s extremely challenging to interpret these biomarker tests. I mean that’s really what these are. They’re biomarkers. They’re trying to help people decide which treatment to offer their patients and these biomarkers are rapidly changing as fast as the drugs are changing. You have to keep up to date on it and have a way to systematically review this information; otherwise, it could be misinterpreted or you could miss out on options for your patients.
Dr. Powell: Whenever we run a study, even an observational study, we’re able to utilize the BioBank as a bio repository to store either tumor specimens or blood specimens or both. So when patients consented to go on the GEMMA study, they had a blood draw done at the same time they had their genomic testing done, and if they had a new biopsy, they also had the option to have their tumor stored as well. The bank also serves as a tool for retrospective research whenever you’re doing this sort of testing, and this is just how we’re using it for oncology.
Dr. Powell: We have a huge health system, and it was a challenge to try to bring everybody together. I think that, at the end of the day, our physicians were committed. They really wanted this as an option to help them try to identify treatments for patients. We were set with a task when we started this of, “We have this testing. We have these novel treatments like immunotherapies coming out. What can we do to help facilitate treatment in our population?”
This kind of program can be as big as you want and as small as you want. We’ve really developed our program into a very large program where many places can call in, but I could even foresee this working at a two-site community oncology program where you have an outreach site and that clinician just wants to have that opportunity weekly to review cases. You could make it as easy as that. As long as you’re reviewing this information and looking into evidence-based treatment options, it’s going to benefit the patients. We’re out here to try to find the best treatments for our patients, and I think that these tumor boards can serve as a tool to do that.
Dr. Powell: We’ve been a Community Cancer Oncology Program through the National Cancer Institute for years, and now we are an NCORP site through the NCI-funded Community Oncology Research Program. So we have a commitment to cancer research in the community, and I think that our big area of focus here is cancer care delivery.
We don’t see clinical practice and research as separate. We see them coming together and when we developed this program, it was necessary to have a strong collaboration between both the research and the clinic side. No matter what tumor board it is, whether it be our molecular tumor or our head and neck tumor board, one of the things that we do systematically for every patient is screen them for trial eligibility. We ask whether there is a clinical trial for this patient, because at the end of the day, the only way we’re going to make progress in cancer care is through clinical trials. We know that and we really try to offer every patient a trial if we can.
One thing I want to stress is that there are a number of different cancer programs out there. I’ve worked in academia, I’ve worked through the Veterans Administration, I’ve worked through community oncology, and I think that you can build a program like this in any sort of environment, but you have to have interested parties. You have to have the physicians and caregivers interested. But when it comes down to it, you can make this work, and it’s a great option for your patients.
Dr. Powell: I’ve served as the physician champion for our molecular tumor board. For each tumor board, we’ve asked physicians to step up and say, “I want to be the champion of this.” The physicians champion each tumor board based on their interest. Then it’s absolutely necessary to have help from administration.
Sharon Hunt, our Vice President of Cancer Services, has been very important. She has a very strong background in cancer genomics, biomarkers, and clinical trials and she has a very strong motivation to [support] that. Her counterpart, Lora Black, our Director of Oncology Research, has been a big champion of it as well.
So championing comes from all those directions as well as from the nursing level and pharmacy level. Our nurse navigators have been huge proponents of this; they work extremely hard to try to bring patient cases forward, get patients reviewed at the tumor boards, and then deliver the information back to the patients. You have to have champions from every angle and buy-in from everybody.
Watch this video from 2016 ICLIO Innovator Award winner Sanford Health and hear how their goal of increasing patient access to immunotherapy clinical trials is supported by discussion and education on immunotherapy integrated into their regularly scheduled molecular tumor boards.