Abstract

Ovarian cancer remains the number one gynecological killer in the Western world. Most ovarian cancer patients present with advanced-stage disease and are treated with cytoreductive surgery followed by combination chemotherapy. While the majority of patients respond to treatment, most will relapse such that the 5-year survival rates for advanced disease are approximately 20–25%. Overall survival and progression-free survival (PFS) are the primary endpoints in clinical trials in patients with advanced ovarian cancer. In patients with early-stage ovarian cancer, PFS may be the preferred trial endpoint, whereas in patients with recurrent ovarian cancer, the primary goal of therapy remains palliation and control of symptoms. Recent studies in recurrent disease have demonstrated that chemotherapy can improve the endpoints of PFS and overall survival, and so they are being used as the primary endpoints for comparing new regimens in phase III trials in relapsed patients. However, it would be easier to compare new treatment modalities if a uniformly accepted instrument was available that could evaluate quality of life and symptom control.