Bristol Myers Squibb Foundation Selects and Funds Sylvester Researcher for Its Diversity in Clinical Trials Career Development Program

The Bristol Myers Squibb Foundation and National Medical Fellowships have selected Sylvester Comprehensive Cancer Center researcher Kristin E. Rojas, MD, FACS, for its inaugural Diversity in Clinical Trials Career Development Program, which includes a two-year $240,000 grant for her research “Effects of Perioperative Opioids on Gut Microbiome Composition in Breast Cancer Patients.”

The Clinical Trials Career Development Program recognizes community-oriented clinical researchers for their outstanding professional achievements and promise. Dr. Rojas, assistant professor of surgical oncology in the Dewitt Daughtry Department of Surgery and Sylvester Comprehensive Cancer Center, is among a distinguished group of physicians and one of six surgeons selected for the Foundation’s initiative to strengthen partnerships between clinical investigators and communities, increase the diversity of patients enrolled in clinical trials, and enhance the development of therapeutics for all populations.

Dr. Rojas’s research on opioid sparing strategies in breast cancer surgery have been published in the Annals of Surgical Oncology and other scientific journals.

“We have shown that opioid-sparing pain management in cancer surgery is safe, feasible and may actually improve postoperative pain control” Dr. Rojas said.

In fact, Dr. Rojas and colleagues have reported that pain control using non-opioid multimodal analgesia protocols with such medications as acetaminophen and nonsteroidal anti-inflammatory drugs result in less pain among surgical patients compared to patients prescribed traditional opioid-based regimens.

“This award will give me the resources to take our work to the next step by providing a mechanism in which opioids may worsen cancer outcomes through translational research. The first leg was a proof-of-concept, to show that there are alternatives to opioids in breast cancer surgery; this next step is to show that minimizing or eliminating opioids should be done in breast cancer surgery because it may impact oncologic outcome,” she said.

Sabita Roy, PhD, professor of surgery at Sylvester and a world leader in research looking at the impact of opioids on the microbiome, is mentoring Dr. Rojas for “Effects of Perioperative Opioids on Gut Microbiome Composition in Breast Cancer Patients.”

“Our group recently described how opioids promote carcinogenesis through pathogenic changes in the gut microbiome in preclinical cancer models,” according to the study’s abstract. “…there is a critical need to assess the effects of opioids in developing gut dysbiosis and its subsequent inflammatory cascade in a diverse cohort of cancer patients to better understand their role in promoting adverse oncologic outcomes.”

Preliminary work by Dr. Rojas and other researchers seems to have helped to lessen opioid use for patients having breast-conserving lumpectomy procedures.

“I was honored to contribute to the American Society of Breast Surgeons Pain Management Consensus Guidelines in 2020 that provided a framework for other breast surgeons to limit superfluous opioid prescribing,” she said. “But I think surgeons still prescribe opioids almost universally for patients undergoing mastectomy.”

Dr. Rojas and colleagues will study 48 South Florida breast cancer patients. Half will receive opioids to control pain related to breast cancer surgery and half will receive her opioid-sparing multimodal analgesia protocol for pain control. The researchers will stratify patients in the study by Hispanic and non-Hispanic ethnicity to account for differences in outcomes by ethnicity.

“The primary outcome is to prove that even short-term opioids given at the time of surgery have a negative impact on the gut microbiome,” she said. “We also need to be looking at ethnicity in order to account for all possible differences in microbiome composition.”

Sylvester and the University of Miami Miller School of Medicine are in the ideal location for such a study.

“Florida has been particularly hard hit by the opioid epidemic. We also have a richly diverse population and can contribute a diverse cohort to this research,” Dr. Rojas said. “This is critical for the future of quality research and one of the forces behind the Bristol Myers Squibb Foundation program. Our guidelines are based on studies of mostly white educated populations and that is not the only face of the patients that we treat. To provide the best care for cancer patients, we need to make sure that the treatments that we are studying and saying are best have been proven to be effective in the patients that we serve.”

The Bristol Myers Squibb Foundation funding also includes training and mentoring to support clinical investigators’ ability to advance health equity through research and mentoring. Dr. Rojas will be mentored in the first year of the program and, in the second year, will mentor a medical student that represents the next generation of diverse clinical researchers.

“This is exciting not only because my project is going to be funded, but also because I am part of a program that focuses on career development and promoting diversity among primary investigators,” Dr. Rojas said.