by Lauren Comander
Sophia George, Ph.D., and Matthew Schlumbrecht, M.D., M.P.H., are taking on the world of ovarian cancer research. As researchers for Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, the duo is focused on African ancestry.
With an already-launched multicenter study on the safety, tolerability and metabolism of ovarian cancer drug niraparib in the U.S. and the Caribbean, Drs. George and Schlumbrecht extended their reach in July to Africa, giving them access to data from a population previously underrepresented.
While care for certain ovarian cancer patients has been revolutionized by PARP inhibitors like niraparib, Black women account for just 1.6% of the participants in the PRIMA study for niraparib. Quite to the contrary, this new study is specifically for women of African descent.
Drug Effectiveness and Access
“We know from other drugs that how women of African ancestry metabolize drugs can differ from those of European ancestry,” said Dr. Schlumbrecht, a Sylvester researcher and associate professor of gynecological oncology who studies gynecologic cancer disparities. “We need to know these drugs are safe and effective in this population. I have Black patients who often ask if specific drugs will work for them, and I don’t have answers for them. The data we gain from this will ultimately allow us to confirm appropriate dosing, counsel patients on side effects, lobby governments for coverage of this drug and globally decrease inequities in outcome by expanding access.”
As a testament to the study’s promise in helping its researchers better understand what drives health inequities, identify genetic characteristics specific to African heritage and uncover environmental factors that improve treatment for women with ovarian cancer, the study was specifically highlighted by the White House in its fact sheet for the Biden Cancer Moonshot.
The Cancer Moonshot initiative set a national goal to reduce the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living with and surviving cancer.
“This recognition by the White House illustrates the importance of what we are doing with this study, increasing our ability to successfully identify and treat women of all backgrounds with ovarian cancer,” said Dr. George, a Sylvester molecular geneticist and associate professor of gynecological oncology, noting that September is Gynecological Cancer Awareness Month.
Global Approach Informs Clinical Practice
The doctors will enroll patients in the study from the Bahamas site in the Caribbean, the Florida site in the U.S. and the newest site in Nigeria over the next three years. They will follow the patients for much longer, conducting ancillary studies on the pharmacokinetics of circulating tumor DNA as a biomarker of recurrence.
They will also examine the profiles of homologous recombination deficiency to determine if the drug works as anticipated on a molecular level. Moreover, the studies will research the impact on patients’ quality of life.
“We want to clearly describe in a population of Black women the side effect profile of niraparib, the effectiveness in terms of outcomes and if dosing modifications need to be made up front,” Dr. Schlumbrecht said. “It is also important for us to understand that not all Black women are the same and that there is significant variation. By taking a global approach in this study and including Nigeria and the Bahamas, we are informing clinical practice here at home.”
The roots between Sylvester and Nigeria run deep, with the study’s expansion growing from a partnership forged in 2019 between Drs. George and Schlumbrecht and their colleagues there, especially Professor Bala Audu, president of the Nigerian Medical Association and vice chancellor at the Federal University of Health Sciences, Azare. The researchers mentor their Nigerian colleagues on research studies. Dr. Schlumbrecht conducts monthly tumor boards, teaches rounds and performs surgeries with trainees on patients with cervical cancer.
Collaboration Provides Advancement
Because of this close collaboration, Dr. Schlumbrecht said it only made sense to conduct the trial at the Ahmadu Bello University Teaching Hospital (ABUTH) in Zaria, where gynecologic oncologists serve in Sylvester’s cofounded TransAtlantic Gynecologic Cancer Research Consortium.
In launching the study at the International Convening in Cancer Research and Collaboration conference in Abuja, Nigeria in July, Drs. George and Schlumbrecht presented on the latest advancements in gynecologic oncology and clinical trials. They also discussed leveraging transatlantic collaboration in cancer research and management.
It was Dr. Schlumbrecht’s fifth trip to the country, and he will continue to visit to supervise and operate alongside trainees, as well as ensure the research study is running smoothly.
“The clinical trial is really a team effort,” he said. “It is the result of long-standing collaborations over the years and a shared interest in eliminating ovarian cancer disparities in Black women. This is an example of how we can be successful when we work together and not in isolated silos.”
This article was published by: University of Miami Miller School of Medicine