O Cyst

Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin a Resected Stage III Ovarian Cancer: A Gynecologic
Oncology Group Study 6/20/15, 1:56
Journal of Clinical Oncology

jco.ascopubs.org
Published online before print July 14, 2003, doi: 10.1200/JCO.2003.02.153

JCO September 1, 2003 vol. 21 no. 17 3194-3200
2003 by American Society of Clinical Oncology
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 and Rebecca Baergen
+ Author Affiliations
Address reprint requests to Denise Mackey, Gynecologic Oncology Group, Four

Penn Center, 1600 JFK Blvd, Suite 1020, Philadelphia, PA 19103; e-mail:
dmackey@gog.org.
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/m2 over 3 hours (arm II). Advertisement
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.
Footnotes
Supported by National Cancer Institute grants to the Gynecologic Oncology

Group Administrative Office (CA 27469) and the Gynecologic Oncology Group
Statistical Office (CA 37517).
Received February 27, 2003.

Accepted June 4, 2003.
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Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin a Resected Stage III Ovarian Cancer: A Gynecologic

Oncology Group Study 6/20/15, 1:56

Journal of Clinical Oncology

Published online before print July 14, 2003, doi: 10.1200/JCO.2003.02.153

2003 by American Society of Clinical Oncology

Phase III Trial of Carboplatin and Paclitaxel

Address reprint requests to Denise Mackey, Gynecologic Oncology Group, Four

Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen

Supported by National Cancer Institute grants to the Gynecologic Oncology

Received February 27, 2003.

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