Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial
July 1, 2003
Do 3 or 12 cycles of maintenance paclitaxel improve PFS in women who achieved compete response to primary platinum-based therapy?
paclitaxel 175mg/m2 over 3hrs q28 days x3 cycles
paclitaxel 175mg/m2 over 3hrs q28 days x12 cycles
stage III/IV epithelial ovarian cancer5-6 cycles of platinum-based chemotherapycomplete response
interim analysis, early termination boundary crossedpaclitaxel 3 cycles (n=128) vs paclitaxel 12 cycles (n=134):grade 2/3 neuropathy: 15% vs 23%median PFS: 21 vs 28 mos (SS)no OS difference
12 cycles of maintenance paclitaxel administered to women who achieved complete response improves PFS