Ovarian Cancer上皮性卵巢癌课件.ppt

Intraperitoneal Chemotherapy Results 415 patients Serous histology (86%) Grade 3 (51%) Microscopic residual disease (37%) 52% of patients finished less than 4 cycles of IP chemotherapy IV IP P value N 210 205 Completed 6 cycles 83% 42% Grade 3-4 Leukopenia GI Fatigue Metabolic Pain Thrombocytopenia Neuropathy Infection 64% 24% 4% 7% 1% 4% 9% 6% 76% 46% 18% 27% 11% 12% 19% 16% p0.001 p0.001 p0.001 p0.001 p0.001 p=0.002 p=0.001 p=0.001 Deaths 127 (60%) 101 (49%) PFS 18.3 mo 23.8 mo RR 0.77 (95% CI), p=0.05 OS 49.7 mo 65.6 mo RR 0.73 (95% CI), p=0.03 Intraperitoneal Chemotherapy Conclusions IP chemotherapy had a significantly better PFS and OS for women with optimally cytoreduced Stage III EOC Significant toxicity with IP chemotherapy (only 40% of women completed 6 cycles) Most patients had abdominal port/catheter issues that resulted in conversion to IV carboplatin rather than IP chemotherapy Opponents of IP chemotherapy argue that the IP regimen is not being compared to the current standard of care (Carboplatin and Taxol) Proponents argue that Cisplatin and Taxol is equally effective as Carboplatin and Taxol (GOG #158) Consolidation Chemotherapy Markman M et al. 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. J Clin Oncol 2003; 21: 2460-5. GOG #178 Phase III, randomized, controlled trial Objective- to evaluate PFS among women with advanced ovarian cancer the efficacy of Carboplatin and Paclitaxel vs. Cisplatin and Paclitaxel Consolidation Chemotherapy Methods- Eligibility: Stage III Stage IV Treatment with 5-6 cycles of platinum/paclitaxel Clinical complete response (normal exam, normal CT scan, CA-125 ≤35) Primary endpoint PFS- measured from the date of randomization “The median PFS after a clinical complete response to inducti