Individualized Treatments and Clinical Trial Endpoints in Ovarian Cancer

Clinical Pearls

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses clinical trial endpoints and individualizing treatment in patients with ovarian cancer.

• The last approved agent in advanced epithelial ovarian cancer was the carboplatin + gemcitabine doublet used in platinum-sensitive recurrence
• This doublet was approved based on a PFS endpoint
• Since then, it has been difficult to get ovarian cancer drugs approved based on a PFS endpoint
• The challenge remains to see the value of PFS
• Maintaining long term tumor control, though of value to the patient, may not be of value to regulators
• Though certain agents may be equally efficacious, they may have different toxicity profiles
• Ideally, clinicians need agents approved on a PFS endpoint in order to individualize treatments