High-dose chemotherapeutic approaches to ovarian cancer management.

The effect of high-dose chemotherapy on the survival of women with ovarian cancer has been studied in numerous clinical trials. Approaches to dose intensity have included high-dose chemotherapy, combination platinum therapies, intraperitoneal therapy, and stem cell-supported high-dose chemotherapy. Taken together, the data demonstrate increased response rates with high-dose regimens, but any survival advantages observed have been limited. Patients with the most favorable outcome are those with low tumor burden and chemotherapy-sensitive tumors. An attempt to study this group of patients in a randomized trial in the United States (Gynecologic Oncology Group Protocol 164) was unsuccessful because of low accrual. Reasons for low accrual included physician bias, patient bias, and lack of third-party payer support. European randomized trials are under way to evaluate high-dose chemotherapy and stem cell transplantation as part of initial therapy or as consolidation after initial response to therapy and to compare high-dose chemotherapy with standard-dose chemotherapy. Until results from these trials become available, high-dose therapy remains limited to the clinical trial setting.

RCT Entities:   Population Interventions Outcomes