Three cycles versus six cycles of adjuvant paclitaxel (Taxol)/carboplatin in early stage ovarian cancer.

The optimal management of early stage ovarian cancer with poor prognostic features remains controversial. On the basis of results of studies in advanced ovarian cancer, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in combination with a platinum agent has become part of adjuvant chemotherapy trials in early stage disease. Because the optimal number of chemotherapy cycles has not been determined, the Gynecologic Oncology Group is conducting a study comparing three cycles with six cycles of adjuvant paclitaxel/carboplatin in high-risk patients with early stage ovarian cancer. At a median follow-up period of 3 years, 290 (88%) of the 331 evaluable patients on both arms of the trial were alive and recurrence free. Regimen B (treatment groups have not yet been unblinded) was associated with a somewhat higher incidence of grade 3/4 leukopenia and a markedly higher frequency of grade 2-4 neurologic toxicity. Final results from this study will reveal any difference in overall or progression-free survival between the two regimens.

RCT Entities:   Population Interventions Outcomes