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