At the General Meeting of the American Society of Clinical Oncology (ASCO) in June, BCRF researcher, Dr. Monica Bertagnolli, was named as the organization’s 2018 President-Elect. Her term will begin in June 2018. Dr. Bertagnolli is a renowned surgical oncologist who serves in numerous leadership positions including as chief of the division of Surgical Oncology at Dana-Farber/Brigham and Women’s Cancer Center, professor of surgery at Harvard Medical School, associate surgeon at Brigham and Women’s Hospital and Dana-Farber Cancer Institute, and group Chair of the Executive Committee of the Alliance for Clinical Trials in Oncology.
Her BCRF-supported work is focused on the molecular analysis of tumor specimens from clinical trials. These efforts are critically important for the development of biomarkers that can predict risk of recurrence, response to treatment, as well as the identification of new treatment for drug-resistant tumors in breast cancer.
BCRF had a chance to speak with Dr. Bertagnolli who shared her views on the developments in clinical cancer research and what she hopes to achieve in her term as ASCO president.
BCRF: How has the national clinical trials system changed over the years? What are the challenges facing clinical research?
Dr. Bertagnolli: The national clinical trial cooperative groups were established in the 1950’s as part of the National Cancer Institute’s chemotherapy program to execute the complex clinical trials that were needed test new cancer therapeutics being developed by the agency. There have been big changes in the last 60 years, in the role of pharma, the conduct of clinical trials and the role of the FDA in drug development, etc., and a major restructuring of the federally funded groups, now known as the National Clinical Trials Network (NCTN) was spurred by an Institute of Medicine Report in 2011. The report recommended a more dynamic and collaborative clinical trials system, one that leveraged new knowledge, technology and collaboration to more quickly advance practice changing research. As a result, clinical trials activate more quickly; many incorporate molecular profiling, biomarker development and the development of companion diagnostics. One example of where we’re really seeing this is the explosion in immuno-oncology. These are all exciting, positive changes.
There is one caveat, and that is that federal funding has remained flat to declining (accounting for inflation) in the last decade and because of this, the number of people enrolled in clinical trials has declined. Fortunately, we are seeing more collaboration from industry both with the NCI and with the NCTN groups themselves. There is a recognition that public-private partnership for cancer research is critically important. It is a win-win in many cases for the pharmaceutical companies and the patients.
But private-public partnerships are not always an option, particularly in cases where no drug is involved. Examples include studies to understand the role of MRI in breast cancer staging, the transformative studies in lymph node dissection or studies to address the disparities in cancer care and access to clinical trials. These are practice-changing studies, but there is not a vested interest from private industry to support these kinds of trials. The NCI-supported NCTN is therefore crucial for doing high impact research of this type. In the Alliance clinical trial portfolio alone, 60-70 percent of clinical trials fall into this category and simply would not exist without public funding.
BCRF: How does precision medicine, or treating each patient based on his or her unique biology and tumor characteristics, change the way clinical trials are conducted?
Dr. Bertagnolli: The goal is that every cancer patient gets the best cancer care and if appropriate, access to a clinical trial. Precision medicine creates new challenges, but opportunities as well. One of the challenges is that everything becomes a rare disease when you’re trying to find patients that fit very narrow enrollment criteria, for instance, a specific tumor mutation. We need to have enough patients for the data to be meaningful, but that gets very difficult with a small study population. In order to achieve the goals of precision medicine, all stakeholders–government, industry and academia– have to collaborate at an unprecedented level. Because of this, I am looking to precision medicine initiatives to break down barriers to collaboration. The benefits are the acceleration of research and implementation of new therapies for patients, and it is very important that the Precision Medicine Initiative is a publicly funded endeavor, also supported whenever appropriate by private companies.
BCRF: Looking ahead to your term as ASCO president in 2018, what do you think will be your priorities for ASCO?
Dr. Bertagnolli: Before I became involved in national and international clinical trials, I was in the cancer prevention field, studying a rare genetic disease called familial adenomatous polyposis that predisposes families to colon cancer. What I am most passionate about and will be a priority of my ASCO presidency is to ensure that every cancer patient has access to the very best possible clinical care and clinical research. It will be about tackling disparities in access to cancer care and outcomes. Just like the challenge of precision medicine, it will take all the stakeholders, not just the oncology community, but government, policy makers, state medical societies and most importantly, patient advocates to achieve that goal.
BCRF: What are you most excited about at the ASCO Annual Meeting?
Dr. Bertagnolli: I’m excited about the collaborative initiatives that are answering important questions about how to deliver the best care. One abstract presented at the meeting is from a collaborative group called the IDEA collaborative that was led by the late Dan Sargent to look at adjuvant chemotherapy in colon cancer. It answers a very basic question about when and how much chemotherapy do we need to give a patient after surgery. It’s a question that could not be answered by any one trial and took a consortium of many different international groups pooling together data from many trials.
I am also very excited by the work of Basch, et al, which showed that patients receiving treatment for metastatic cancer who used a web-based tool to report their symptoms either while at home or during clinic visits lived on average 5 months longer than their counterparts who had standard symptom reporting. This essentially shows that patients live longer and better when they can communicate effectively with their care team.
BCRF: How has BCRF funding supported the efforts of the Alliance?
Dr. Bertagnolli: BCRF funding has been crucial in having the freedom to address the areas of the most impact and the most need. The ability to be flexible is so important in research as opportunities for impact are identified. With BCRF funding, I know that projects can go forward with security that might be cut short without BCRF support.
Read more about Dr. Bergtanolli’s BCRF research here.
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