Phase III Trial of Induction Gemcitabine or Paclitaxel Plus Carboplatin Followed by Elective Paclitaxel Consolidation in Ovarian Cancer: Interim Analysis of Induction Chemotherapy

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Background:Combination paclitaxel and carboplatin (TC) is the standard of care for first-line (induction) treatment of ovarian cancer. Gemcitabine plus carboplatin (GC) is approved for recurrent platinum-sensitive ovarian cancer. This trial compared the safety and efficacy of GC and TC induction regimens followed by elective paclitaxel consolidation. This interim report is limited to induction-phase toxicity and response data for approximately one half of randomized patients.Patients and Methods:Patients diagnosed with stage IC-IV ovarian cancer were randomized to 1 of 2 induction arms: GC (gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under the curve [AUC] 5 on day 1) or TC (paclitaxel 175 mg/m2 plus carboplatin AUC 6 on day 1). Up to six 21-day cycles were permitted. Patients with complete response (CR) were allowed consolidation therapy with paclitaxel 135 mg/m2 every 28 days up to 12 months. Non-CR patients received singleagent crossover therapy (GC to paclitaxel, TC to gemcitabine) at induction doses/schedules until CR, disease progression, or unacceptable toxicity. Toxicities were assessed using National Cancer Institute Common Toxicity Criteria, version 2.0. Best response was assessed by Response Evaluation Criteria in Solid Tumors.Results:Of 919 enrolled patients, results for the first 437 are provided. Grade 3/4 anemia, thrombocytopenia, and platelet transfusions were significantly greater for GC, whereas grade ≥ 2 neuropathy and grade ≤ 2 alopecia were significantly greater for TC. Significantly more (P < .001) GC patients (n = 87; 40.7%) had at least one induction dose reduced compared with TC patients (n = 29; 13.6%). Response rates for evaluable patients were not statistically different in each arm.Conclusion:Toxicity profiles for induction arms were consistent with previous clinical experience. Response results were similar for each arm.

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