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Journal of Clinical Oncology, Vol 19, Issue 4 (February), 2001: 1001-1007
© 2001 American Society for Clinical Oncology

Phase III Trial of Standard-Dose Intravenous Cisplatin Plus Paclitaxel Versus Moderately High-Dose Carboplatin Followed by Intravenous Paclitaxel and Intraperitoneal Cisplatin in Small-Volume Stage III Ovarian Carcinoma: An Intergroup Study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group

By Maurie Markman, Brian N. Bundy, David S. Alberts, Jeffrey M. Fowler, Daniel L. Clark-Pearson, Linda F. Carson, Scott Wadler, Joshua Sickel

From the Cleveland Clinic Taussig Cancer Center, Department of Hematology/Medical Oncology, The Cleveland Clinic Foundation, Cleveland, OH; Gynecologic Oncology Group, Roswell Park Cancer Institute, Buffalo; Gastrointestinal Oncology Program, Albert Einstein College of Medicine, Bronx; and Department of Pathology and Laboratory Medicine, Strong Memorial Hospital, University of Rochester, Rochester, NY; Pharmacology and Public Health, College of Medicine, University of Arizona, Tucson, AZ; Ohio State University, James Cancer Hospital and Solove Research Institute, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbus, OH; Duke University School of Medicine, Durham, NC; and Division of Gynecologic Oncology, University of Minnesota, Hennepin County Medical Center, Minneapolis, MN.

Address reprint requests to GOG Administrative Office, Suite 1945, 1234 Market St, Philadelphia, PA 19107. © 2001 by American Society of Clinical Oncology. 0732-183X/01/1904-100

PURPOSE: To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous (IV) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin.

PATIENTS AND METHODS: Patients were randomized to receive either IV paclitaxel 135 mg/m2 over 24 hours followed by IV cisplatin 75 mg/m2 every 3 weeks for six courses or IV carboplatin (area under curve 9) every 28 days for two courses, then IV paclitaxel 135 mg/m2 over 24 hours followed by intraperitoneal (IP) cisplatin 100 mg/m2 every 3 weeks for six courses.

RESULTS: Of the 523 patients who entered this trial, 462 were determined to be assessable, with prognostic factors well balanced between the treatments. Neutropenia, thrombocytopenia, and gastrointestinal and metabolic toxicities were greater in the experimental arm. As a result, 18% of the patients received <= two courses of IP therapy. Progression-free survival was superior for patients randomized to the experimental treatment arm (median, 28 v 22 months; relative risk, 0.78; log-rank P = .01, one-tail). There was a borderline improvement in overall survival associated with this regimen (median, 63 v 52 months; relative risk, 0.81; P = .05, one-tail).

CONCLUSION: An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is not recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.


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