Identifying New Clinical Trial Endpoints in the Treatment of Ovarian Cancer
Posted: Thursday, April 26, 2018
Surrogate endpoints such as progression-free survival and overall response rate could serve as viable primary endpoints in clinical trials for the treatment of ovarian cancer. This was one of many topics addressed in a white paper from the Society of Gynecologic Oncology published in Gynecologic Oncology, which highlighted findings and discussions from a workshop featuring the U.S. Food and Drug Administration and prominent cancer research groups.
“Ongoing communication among stakeholders and continual improvement in clinical trial designs that consider innovative designs incorporating real-world data to best reflect true patient benefit will best serve our ovarian cancer community,” concluded lead author Thomas J. Herzog, MD, of the University of Cincinnati Cancer Institute.
Among the topics discussed, a consensus opinion was formed about the use of progression-free survival and overall response rate under certain conditions. Those conditions include the magnitude of the efficacy endpoint, particularly the duration of response as well as consideration of toxicities and their impact on the patient’s quality of life. Patient-reported outcomes, researchers said, are also valuable to illuminate true patient net benefits.
Other highlights include the use of neoadjuvant chemotherapy on patients with ovarian cancer. Researchers acknowledged that neoadjuvant chemotherapy as a unique method to review in-treatment effects of therapy but identified several key issues to be addressed before it can be used as a regulatory tool. Researchers also stressed the need for further classification of ovarian cancer beyond a “one-size-fits-all” approach; focus should be on recognizing newly diagnosed and recurrent cancer including multiple descriptive factors with prognostic impact.