Abstract: |
The Gynecologic Oncology Group initiated a study to evaluate combination paclitaxel (Taxol®, Bristol-Myers Squibb Company)-cisplatin vs standard therapy with cyclophosphamide-cisplatin as primary therapy for patients with suboptinally debulked advanced ovarian cancer. The 386 eligible patients were randomly assigned to treatment with either cisplatin 75 mg m-2 plus cyclophosphamide 750 mg m-2 or the same dose of cisplatin plus paclitaxel 135 mg m-2 given over 24 h. Response to therapy was assessed in 216 patients with clinically measurable disease. In the standard therapy arm, overall response was 60%, with a 31% rate of complete response. In the paclitaxel-based treatment group, the overall response was 73%, and 51% of patients achieved a complete response. Although neutropenia, fever, alopecia, and peripheral neuropathy were more common in the paclitaxel-treated patients, myelosuppression was generally brief and nonhematologic toxicities were mild. Both overall and progression-free survival significantly favored patients treated with paclitaxel-cisplatin: overall survival was 37.5 vs 24.4 months, and progression-free survival was 17.9 vs 12.9 months for the paclitaxel- and cyclophosphamide-treated groups, respectively. Paclitaxel- cisplatin offers prolonged survival and progression-free survival without increasing toxicity when used as first-line therapy for patients with suboptimally debulked ovarian cancer. |