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Adjuvant Treatment for Early Ovarian Cancer: A Randomized Phase III Trial of Intraperitoneal ³²P or Intravenous Cyclophosphamide and Cisplatin—A Gynecologic Oncology Group Study

Robert C. Young, Mark F. Brady, Roberta K. Nieberg, Harry J. Long, Allan R. Mayer, Samuel S. Lentz, Jean Hurteau, David S. Alberts

From the Fox Chase Cancer Center, Philadelphia, PA; Roswell Park Cancer Institute, Buffalo, NY; University of California Los Angeles Medical Center, Los Angeles, CA, Mayo Comprehensive Cancer Center, Rochester, MN; Walter Reed Army Medical Center, Washington, DC; Wake Forest University School of Medicine, Winston-Salem, NC; Indiana University School of Medicine, Indianapolis, IN; and the University of Arizona College of Medicine and Arizona Cancer Center, Tucson, AZ.

Address reprint requests to Denise Mackey, Gynecologic Oncology Group, Administrative Office, Four Penn Center, 1600 John F. Kennedy Blvd, Suite 1020, Philadelphia, PA 19103; e-mail: rc_young{at}fccc.edu.

Purpose: To conduct a prospective study of intraperitoneal radioactive chromic phosphate (³²P) versus cyclophosphamide-cisplatin (CP) in women with early ovarian cancer at high risk for recurrence (International Federation of Gynecology and Obstetrics stage Ia or Ib grade 3 or Ic or stage II, no macroscopic residual disease) and to compare cumulative incidence of recurrence, overall survival, and relative toxicity.

Materials and Methods: A total of 251 patients were randomly assigned to treatment with ³²P or CP. Twenty-two (8.7%) were ineligible following centralized pathology review. Of the 229 patients included in the analysis, 110 received ³²P, and 119 received CP.

Results: The cumulative incidence of recurrence at 10 years was 35% (95% CI, 27% to 45%) for patients receiving ³²P and 28% (95% CI, 21% to 38%) for those receiving CP. Patients receiving CP had a recurrence rate 29% lower than that of those receiving ³²P (P = .15, two-tail test). The death rate for patients treated with CP was 17% lower than that for patients treated with ³²P (difference not significant). Combining both arms, the 10-year cumulative incidence of recurrence for all stage I patients was 27% (95% CI, 20% to 34%) compared with 44% (95% CI, 32% to 56%) for stage II patients (P = .01). Both regimens were reasonably well tolerated, but problems with inadequate distribution (7%) and small-bowel perforation (3%) make the otherwise less toxic ³²P less acceptable.

Conclusion: Although there are no statistically significant differences in survival, the lower cumulative recurrence seen with CP and complications of ³²P administration make platinum-based combinations the preferred adjuvant therapy for early ovarian cancer patients at high-risk for recurrence.

Supported by National Cancer Institute grants to GOG member institutions participating in this study.

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Related Correspondence

• Observations on the Interpretation of Clinical Trials in Early Ovarian Cancer
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  JCO 2005 23: 927 [Full Text]

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