Dr. Monk on Trial Endpoints For Ovarian Cancer Agents

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, on clinical trial endpoints and the approval of agents for ovarian cancer.

The last approved agent in advanced epithelial ovarian cancer was the doublet of carboplatin and gemcitabine for platinum-sensitive recurrence. This doublet was approved based on a progression-free survival (PFS) endpoint. Since then, Monk says, it has been difficult to get ovarian cancer drugs approved based on a PFS endpoint, as challenges remain to see the value of PFS.

Monk states that maintaining long-term tumor control is important to a patient, but it may not be as important to regulators. Though some agents may be equally efficacious as one another, they could be associated with different adverse events. Agents approved on PFS endpoints could help to individualize treatments for patients.