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Originally published as JCO Early Release 10.1200/JCO.2003.02.153 on July 14 2003

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Journal of Clinical Oncology, Vol 21, Issue 17 (September), 2003: 3194-3200
© 2003 American Society for 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, Rebecca Baergen

From Medical Science Department, Fox Chase Cancer Center, Philadelphia, PA; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo; Department of Pathology, New York Presbyterian Hospital-Cornell Medical Center, New York, NY; Division of Gynecologic Oncology, University of Washington School of Medicine, Seattle, WA; Division of Gynecologic Oncology, James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH; Gynecologic Oncology and Obstetrics and Gynecology Departments, Duke University School of Medicine, Durham, NC; Division of Gynecologic Oncology, University of California at Irvine, Orange, CA; Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Department of Obstetrics and Gynecology, Rush Medical Center, Chicago, IL; and Division of Gynecologic Oncology, University of Wisconsin, Madison, WI (affiliate of University of Texas Southwestern Medical Center at Dallas, Dallas, TX).

Address reprint requests to Denise Mackey, Gynecologic Oncology Group, Four Penn Center, 1600 JFK Blvd, Suite 1020, Philadelphia, PA 19103; e-mail: dmackey{at}gog.org.

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).

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.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517).


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R. P. Rocconi, J. M. Straughn Jr., C. A. Leath III, L. C. Kilgore, W. K. Huh, M. N. Barnes III, E. E. Partridge, and R. D. Alvarez
Pegylated liposomal Doxorubicin consolidation therapy after platinum/paclitaxel-based chemotherapy for suboptimally debulked, advanced-stage epithelial ovarian cancer patients.
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M. Markman, P.Y. Liu, M. L. Rothenberg, B. J. Monk, M. Brady, and D. S. Alberts
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B. C.-Y. Zee
Planned Equivalence or Noninferiority Trials Versus Unplanned Noninferiority Claims: Are They Equal?
J. Clin. Oncol., March 1, 2006; 24(7): 1026 - 1028.
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Addition of Epirubicin As a Third Drug to Carboplatin-Paclitaxel in First-Line Treatment of Advanced Ovarian Cancer: A Prospectively Randomized Gynecologic Cancer Intergroup Trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
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A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients
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M. Komatsu, K. Hiyama, K. Tanimoto, M. Yunokawa, K. Otani, M. Ohtaki, E. Hiyama, J. Kigawa, M. Ohwada, M. Suzuki, et al.
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M. Markman and J. L. Walker
Intraperitoneal Chemotherapy of Ovarian Cancer: A Review, With a Focus on Practical Aspects of Treatment
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P. Sabbatini and D. R. Spriggs
Consolidation for Ovarian Cancer in Remission
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Randomized Study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group Comparing Quality of Life in Patients With Ovarian Cancer Treated With Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel
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M. Lockley, M. Fernandez, Y. Wang, N. F. Li, S. Conroy, N. Lemoine, and I. McNeish
Activity of the Adenoviral E1A Deletion Mutant dl922-947 in Ovarian Cancer: Comparison with E1A Wild-type Viruses, Bioluminescence Monitoring, and Intraperitoneal Delivery in Icodextrin
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Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study
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Gene Expression Profiles Predict Early Relapse in Ovarian Cancer after Platinum-Paclitaxel Chemotherapy
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Effective Inhibition of Experimental Human Ovarian Cancers with a Targeted Cytotoxic Bombesin Analogue AN-215
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P. G. Rose, S. Nerenstone, M. F. Brady, D. Clarke-Pearson, G. Olt, S. C. Rubin, D. H. Moore, J. M. Small, and the Gynecologic Oncology Group
Secondary Surgical Cytoreduction for Advanced Ovarian Carcinoma
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S. A. Cannistra
Cancer of the Ovary
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R. T. Penson, D. Sahani, and D. A. Bell
Case 37-2004 - A 52-Year-Old Woman with Postmenopausal Bleeding and a Cystic Ovarian Mass
N. Engl. J. Med., December 9, 2004; 351(24): 2531 - 2538.
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Phase III Randomized Trial of Docetaxel-Carboplatin Versus Paclitaxel-Carboplatin as First-line Chemotherapy for Ovarian Carcinoma
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T. J. Herzog
Recurrent Ovarian Cancer: How Important Is It to Treat to Disease Progression?
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A. K. Sood, R. Lush, J. P. Geisler, M. S. Shahin, L. Sanders, D. Sullivan, R. E. Buller, and J. I. Sorosky
Sequential Intraperitoneal Topotecan and Oral Etoposide Chemotherapy in Recurrent Platinum-Resistant Ovarian Carcinoma: Results of a Phase II Trial
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J. S. Berek, P. T. Taylor, A. Gordon, M. J. Cunningham, N. Finkler, J. Orr Jr, S. Rivkin, B. C. Schultes, T. L. Whiteside, and C. F. Nicodemus
Randomized, Placebo-Controlled Study of Oregovomab for Consolidation of Clinical Remission in Patients With Advanced Ovarian Cancer
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S. De Placido, G. Scambia, G. Di Vagno, E. Naglieri, A. V. Lombardi, R. Biamonte, M. Marinaccio, G. Carteni, L. Manzione, A. Febbraro, et al.
Topotecan Compared With No Therapy After Response to Surgery and Carboplatin/Paclitaxel in Patients With Ovarian Cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) Randomized Study
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G. J. S. Rustin, R. C. Bast Jr., G. J. Kelloff, J. C. Barrett, S. K. Carter, P. D. Nisen, C. C. Sigman, D. R. Parkinson, and R. W. Ruddon
Use of CA-125 in Clinical Trial Evaluation of New Therapeutic Drugs for Ovarian Cancer
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M. Gore
Carboplatin Equals Cisplatin: But How Do I Prescribe It?
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