A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer

TitleA randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer
Publication TypeJournal Article
Year of Publication2003
Authorsdu Bois, A, Luck, HJ, Meier, W, Adams, HP, Möbus, V, Costa, S, Bauknecht, T, Richter, B, Warm, M, Schröder, W, Olbricht, S, Nitz, U, Jackisch, C, Emons, G, Wagner, U, Kuhn, W, Pfisterer, J, Group, AGynakologi
JournalJ Natl Cancer Inst
Volume95
Pagination1320-9
KeywordsAdult Aged Antineoplastic Agents, Phytogenic/administration & dosage Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use Carboplatin/administration & dosage Cisplatin/administration & dosage Disease-Free Survival Female Germany Humans Middle Aged Odds Ratio Ov
Abstract

{BACKGROUND: Despite considerable improvement in the treatment of advanced ovarian cancer, the optimization of efficacy and tolerability remains an important issue. Therefore, we performed a randomized, phase III non-inferiority trial comparing paclitaxel plus cisplatin (PT) with paclitaxel plus carboplatin (TC) in patients with advanced ovarian cancer. METHODS: A total of 798 patients with International Federation of Gynecology and Obstetrics stage IIB-IV were randomly assigned to receive six courses of either PT or TC at 3-week intervals. The primary endpoint was the proportion of patients without progression at 2 years. Secondary endpoints included toxicity, response to treatment, quality of life, and overall and progression-free survival time. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (QLQ)-C30, version 2.0. Survival curves were calculated using the Kaplan-Meier method, and hazard ratios were estimated using the Cox proportional hazards model. RESULTS: The proportion of patients without progression at 2 years was not statistically significantly different between the two treatment arms (40.0% for PT versus 37.5% for TC