ARTICLES Randomized Intergroup Trial of Cisplatin–Paclitaxel Versus Cisplatin–Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year Results


Background: A randomized trial conducted by the Gyneco-logic Oncology Group (GOG, study #111) in the United States showed a better outcome for patients with advanced ovarian cancer on the paclitaxel–cisplatin regimen than for those on a standard cyclophosphamide–cisplatin regimen. Before considering the paclitaxel–cisplatin regimen as the new “standard, ” a group of European and Canadian inves-tigators planned a confirmatory phase III trial. Methods: This intergroup trial recruited 680 patients with broader selection criteria than the GOG #111 study and administered paclitaxel as a 3-hour instead of a 24-hour infusion; progres-sion-free survival was the primary end point. Patient sur-vival was analyzed by use of the Kaplan–Meier technique. Treatment effects on patient survival were estimated by Cox proportional hazards regression models. All statistical test

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