Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study

Robert F. Ozols, Brian N. Bundy, Benjamin E. Greer, Jeffrey M. Fowler, Daniel Clarke-Pearson, Robert A. Burger, Robert S. Mannel, Koen DeGeest, Ellen M. Hartenbach, Rebecca Baergen, Denise Mackey

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1578 Scopus citations

Abstract

Purpose: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population. Patients and Methods: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m 2 over 3 hours (arm II). Results: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02). Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.

Original languageEnglish (US)
Pages (from-to)3194-3200
Number of pages7
JournalJournal of Clinical Oncology
Volume21
Issue number17
DOIs
StatePublished - Sep 1 2003

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Ozols, R. F., Bundy, B. N., Greer, B. E., Fowler, J. M., Clarke-Pearson, D., Burger, R. A., Mannel, R. S., DeGeest, K., Hartenbach, E. M., Baergen, R., & Mackey, D. (2003). Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study. Journal of Clinical Oncology, 21(17), 3194-3200. https://doi.org/10.1200/JCO.2003.02.153