© 2003 by Oxford University Press
© 2003 Oxford University Press
ARTICLE |
A Randomized Clinical Trial of Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel as First-Line Treatment of Ovarian Cancer
For the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Ovarian Cancer Study Group
Affiliations of authors: A. du Bois, Department of Gynecology and Gynecologic Oncology, Dr.-Horst-Schmidt-Kliniken, Wiesbaden, Germany, and Department of Gynecology and Obstetrics, St.-Vincentius-Hospital, Karlsruhe, Germany; H.-J. Lück, Department of Gynecologic Oncology, Medizinische Hochschule, Hannover, Germany; W. Meier, Department of Gynecology and Obstetrics, University München-Gro
hadern, Germany; H.-P. Adams, Methodisches Zentrum–GynDat, Dr.-Horst-Schmidt-Kliniken, Wiesbaden; V. Möbus, Department of Gynecology and Obstetrics, University of Ulm, Germany; S. Costa, Department of Gynecology and Obstetrics, University of Frankfurt, Germany; T. Bauknecht, Department of Gynecology and Obstetrics, University of Freiburg, Germany; B. Richter, Department of Gynecology and Obstetrics, University of Dresden, Germany; M. Warm, Department of Gynecology and Obstetrics Klinikum, Stralsund, Germany; W. Schröder, Department of Gynecology and Obstetrics, Rheinisch-Westfälische Technische Hochschule, Aachen, Germany; S. Olbricht, Department of Gynecology and Obstetrics, Medizinische Akademie, Magdeburg, Germany; U. Nitz, Department of Gynecology and Obstetrics, University of Düsseldorf, Germany; C. Jackisch, Department of Gynecology and Obstetrics, University of Münster, Germany; G. Emons, U. Wagner, Department of Gynecology, University of Marburg, Germany; W. Kuhn, Department of Gynecology and Obstetrics, University München rechts der Isar, Germany; J. Pfisterer, Department of Gynecology and Obstetrics, University Kiel, Germany.
Correspondence to: Andreas du Bois, MD, PhD, Dr.-Horst-Schmidt-Kliniken, Dept. of Gynecology and Gynecologic Oncology, Ludwig-Erhard-Str. 100, D-65199 Wiesbaden, Germany (e-mail: dubois.hsk-wiesbaden{at}uumail.de).
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, difference = 2.5%, one-sided 95% confidence interval [CI] = –
to 8.2%). Median progression-free survival time in the TC arm (17.2 months, 95% CI = 15.2 to 19.3 months) and the PT arm (19.1 months, 95% CI = 16.7 to 21.5 months) were also not statistically significantly different; the same was true of median overall survival time (43.3 months, 95% CI = 37.2 to 47.8 months versus 44.1 months, 95% CI = 40.2 to 49.4 months, for the TC and PT arms, respectively). The TC regimen was associated with a higher frequency of hematologic toxicity, but a lower frequency of gastrointestinal and neurologic toxicity, than the PT regimen. Mean global quality-of-life scores at the end of treatment were statistically significantly better in the TC arm than in the PT arm (65.25 versus 51.97, respectively; difference = –13.28, 95% CI = –18.88 to –7.68). Conclusion: The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life, and should, therefore, be considered as an important alternative for standard first-line chemotherapy in patients with advanced ovarian cancer.
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