Trial to investigate impact of genomic tumor boards
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Genomic testing continues to provide oncologists with a wealth of meaningful, treatment-guiding information for a growing number of cancers.
The testing has evolved so rapidly, the task of interpreting the results has become a challenge for clinicians.
Observational studies have indicated that genomic tumor boards — expert panels that interpret these results — may help to optimize treatment for these patients.
To better understand the impact and reach of genomic tumor boards, SWOG Cancer Research Network, with NCI funding, has initiated the randomized, controlled SWOG study S2108CD.
“One of the key things we want to emphasize as we go through this process is, first, how to interpret the results,” Meghna S. Trivedi, MD, MS, assistant professor at Columbia University Medical Center and a researcher on the study, told Healio. “Second, we want to learn how to prioritize the treatment options and understand the different levels of evidence for these actionable, or potentially nonactionable, targets to help physicians make the right treatment decisions for their patients.”
Healio spoke with Trivedi and study co-chair Jens Rueter, MD, chief medical officer of The Jackson Laboratory (JAX), a nonprofit biomedical research organization headquartered in Maine, and medical director of JAX’s Maine Cancer Genomics Initiative, about how genomic tumor boards work and how the trial is assessing their impact and value.
Healio: How did your study come about?
Rueter: JAX developed Maine Cancer Genomics Initiative after receiving a philanthropic donation from a local foundation to bring precision oncology and genomic testing to the state of Maine. When this project was conceptualized, we had just opened our own testing laboratory that was able to do tumor testing and next-generation sequencing of tumor samples. The grant paid for the actual testing. However, we realized early on that probably the biggest barrier to implementation would be in the interpretation of these reports. So, we established an education program around the tests — a curriculum-based didactic program. We also developed a decentralized, virtual program for clinicians across the state and worked with our own internal genomics experts and external consultants to design a genomic tumor board model. We realized quickly that oncologists found this incredibly helpful in interpreting these test reports and making therapeutic decisions. We also had some preliminary data indicating that patients we presented to the genomic tumor board were more likely to be offered targeted therapy afterward. JAX is also a translation research member of SWOG, so I approached a few folks at SWOG and was referred to the cancer care delivery committee, where Dawn L. Hershman, MD, and Scott Ramsey, MD, PhD, invited me to give a presentation. That’s where I met Meghna and we began conceptualizing this project.
Healio: What typically happens when a genomic tumor board meets?
Trivedi: The structure for the tumor boards in this study is based on what Jens and his group have been doing. We will present about four to six cases at each tumor board session, and the sessions will be attended by a multidisciplinary team of genomic experts. We also include the clinical teams of the patients being discussed. The tumor board generally starts with a case presentation, which includes the clinical details of the patient. That leads into the genomic test results. We review the report — all of the findings — and the JAX team assists in the interpretation. The next step is looking at the treatment and therapeutic options based on these genomic findings. That will be guided by a genomic treatment expert, which is a PharmD for the purposes of the study. We have two PharmDs from Moffitt Cancer Center who have a great deal of expertise in running precision medicine programs. They will present the available genomic treatment options and give a summary of the data supporting this use.
Rueter: One of the key components of this program is the JAX clinical knowledge base. There are other similar knowledge bases that exist around the country. They have curated all of the available literature that links a specific treatment approach with a genomic profile. We are going to be utilizing this information, along with the opinions of our expert panels, to formulate the most relevant treatment options based on that profile.
Trivedi: Another thing we plan to address with the genomic tumor board is germline genetics. Now that so many people are getting tumors tested, we sometimes get unexpected findings that the cancer might be related to a germline pathogenic variant. There is a lot of interest in the recent literature about who should be getting germline testing if they have a diagnosis of cancer.
Healio: How will your study investigate the impact and reach of the genomic tumor board?
Rueter: Our primary endpoint is the proportion of patients who are receiving an evidence-based, genome-informed therapy after 6 months of enrollment in this study. Patients are being enrolled at the time their genomic tumor testing is being sent, and before we have any results. After the patient is registered to the study, we will review the different treatments the patient has received over the 6-month period after the testing has been sent. Through a central review, we will determine if any of these are genome-informed therapies. Then we will look at the levels of evidence that support the use of the genome-informed therapy. Not only are we interested in understanding whether the patient got molecularly targeted therapy — we also want to know whether it was done with an appropriate level of evidence. There has been concern about overtreatment with targeted therapies that don’t carry enough evidence to support their use. We’re hoping to use central review and the guidelines established through the JAX clinical knowledge base, and [Association for Molecular Pathway]/ASCO/[College of American Pathologists] guidelines to determine whether the evidence is sufficient to warrant the use of this medication for whatever variant is being targeted.
Trivedi: Another important question is, how much impact does this have on a patient’s OS or their time to treatment discontinuation? We’re going to look at that as a secondary outcome. Finally, we will look at implementation of the intervention. We have implementation objectives where we will conduct mixed methods data collection from the physicians participating in this study using interviews and surveys. We want to understand the barriers and facilitators to implementing a genomic tumor board like this across a broader scale. We hope that will help us refine this intervention to make it more accessible and available to patients who may benefit from it.
For more information :
Jens Rueter, MD, can be reached at The Jackson Laboratory, 600 Main St., Bar Harbor, ME 04609; email: jens.rueter@jax.org.
Meghna S. Trivedi, MD, MS, can be reached at CUIMC/Herbert Irving Pavilion, 161 Fort Washington Ave., New York, NY 10032; email: mst2134@cumc.columbia.edu.