Interview with Carolyn D. Britten, M.D.

Shortly after Britten was appointed to the position, Progressnotes spoke with her about her plans for the division.

PN: Can you give us an overview of how you plan to advance the division?

CB: Over the next three years, I expect to grow the division both in terms of the number of medical oncologists and the programs we offer. Specifically, we will work with our scientists to develop clinical trials that serve our patient population, and we will continue to build an academic fellowship program.

As a division, we want to be a referral center for patient care and research. In addition, we want to serve as the academic home for hematologists and medical oncologists within our institution and in the greater community.

PN: What are some of the most significant trials you’ve opened at MUSC as Director of Phase 1 Clinical Trials and why are they significant?

CB: We have a number of really exciting trials and they fall into two major categories. In the first group are trials of agents that are directed against specific molecular abnormalities within the cancer. In the MUSC Pathology Department, we’re able to sequence our patients’ tumors and identify mutations that are potentially driving those tumors. We have a number of trials that are aimed at targeting those putative drivers, such as AKT, PI3K, and RAF. The second group of exciting trials employs immune checkpoint inhibitors. We used to think that only a handful of tumors were immune responsive. However, recent results with immune checkpoint inhibitors have shown that the immune system is very important in a broad spectrum of tumors. We have participated in first-in-human trials of agents targeting the PD1/PDL-1 axis, and we have upcoming trials that will pair these agents with other novel immunotherapy drugs.

PN: What is the importance of having a robust phase 1 clinical trial program in a cancer center?

CB: Phase 1 trials provide access to novel anticancer drugs for patients with advanced malignancies. These trials often accept patients who have rare cancers or those who’ve had a lot of prior treatment. These patients don’t easily fit into larger phase 2 or 3 trials. Furthermore, phase 1 trials are often the mechanism by which we translate the findings of our own scientists into novel treatment strategies.

PN: The implementation of phase 1 trials across the country is changing, isn’t it?

CB: In this era of personalized medicine, many early-phase cancer trials match the molecular subtype with a specific targeted drug. These trials often incorporate biomarkers in an effort to identify which patients are most likely to benefit. This has changed the way we select patients for phase 1 trials.

In addition, the size of phase 1 trials has changed. In the past, a small phase 1 clinical trial would be followed by phase 2 and then phase 3 trials. But now some phase 1 trials are enrolling a few hundred patients using expansion cohorts. There are a number of reasons for this. First, it potentially allows the drug development timeline to proceed more quickly. Second, it allows one to look for an efficacy signal in the first trial before proceeding to either a randomized phase 2 or phase 3. It’s all about getting the drugs that help patients into the clinic in a timely fashion.

PN: Does having a phase 1 trial then, especially this more abbreviated model, make it more likely we can offer more innovative drugs with some efficacy data to patients in South Carolina?

CB: Phase 1 trials are still primarily exploratory, but yes, participation in these larger trials allows us to offer more patients access to novel therapies in South Carolina.

PN: Do you foresee working with community physicians in some way?

CB: Ultimately, we want to provide community oncologists with a connection to MUSC Health oncologists. Ideally, patients would receive most of their care closer to home, but when they need tertiary- or quartenary-level care, they would come to MUSC Health in Charleston. Highly specialized trials, for example first-in-human phase 1 trials or trials of cell-based immunotherapies, will be performed on campus. But phase 2 and phase 3 trials will be performed both on campus and in the community with our partners. As a starting point, under the leadership of Dr. Chanita Hughes Halbert, AT&T Distinguished Endowed Chair in Cancer Equity and Professor in the Department of Psychiatry and Behavioral Sciences, we have an NCORP grant that provides infrastructure for the implementation of cooperative group trials at community sites. We are currently working with sites in Georgetown and Greenwood, and we expect to extend this opportunity to other locations.

PN: Would you like to elaborate on why you’re putting such emphasis on translational research?