Dr. Markman on Overall Survival as an Endpoint in Ovarian Cancer Trials

Maurie Markman, MD, president of Medicine and Science, Cancer Treatment Centers of America, editor-in-chief, OncologyLive, discusses overall survival (OS) as an endpoint in ovarian cancer clinical trials.

Markman says with all of the progress being made with new drugs and strategies, phase III randomized trials using OS as a primary endpoint is no longer rational. Instead, he suggests that allowing other endpoints and earlier-phase or basket studies as the basis for future regulatory decisions.

Patients with ovarian cancer are now living 1 to 3 years or longer after they finish a trial, therefore, holding that drug or combination to a survival endpoint, when all of the things that might have happened to the patient population during the interim is not controlled is irrational, Markman states. He continues, saying that if a trial shows an extremely positive survival, that would be wonderful, but the point is that enormously positive outcomes can be seen with agents in patients with ovarian cancer, independent of the whether they improved OS in a clinical trial.