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JNCI Journal of the National Cancer Institute 1989 81(19):1464-1471; doi:10.1093/jnci/81.19.1464
© 1989 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 81, No. 19, 1464-1471, October 4, 1989
© 1989 Oxford University Press

Randomized Trial in Advanced Ovarian Cancer Comparing Cisplatin and Carboplatin

C. Mangioni, G. Bolis, S. Pecorelli, K. Bragman, A. Epis, G. Favalli, A. Gambino, F. Landoni, M. Presti, W. Torri, L. Vassena, F. Zanaboni, S. Marsoni*

Clinica Ostetrico-Ginecologica, Ospedale S. Gerardo Milan, Italy
III Clinica Ostetrico-Ginecologica), Università di Milano Milan, Italy
Clinica Ostetrico-Ginecologica, Università di Brescia Brescia, Italy
Pharmaceutical Research and Development Bristol-Myers, Brussels, Belgium
Istituto di Ricerche Farmacologiche Mario Negri Milan, Italy

*Correspondence to: Dr. S. Marsoni, Istituto M. Negri, Via Eritrea 62, Milan 20157, Italy.

The aim of this multicenter randomized trial was to compare carboplatin (400 mg/m2) and cisplatin (100 mg/m2) in patients with untreated advanced epithelial ovarian cancer. Toxicity and treatment efficacy assessed by pathological response rate, progression-free survival, and survival were the endpoints of the study. One hundred seventy-three patients with advanced epithelial ovarian cancer, F.I.G.O. (International Federation of Gynecology and Obstetrics) stages III and IV were accrued in the trial. The median follow-up time was 15 months (maximum, 34); three patients in each treatment arm were not eligible (four, nonepithelial ovarian cancer type; one, no data, and one, stage II). Patient characteristics were similar in the two groups. In the carboplatin-treatment arm, the overall pathological response rate was 57.3% and the complete pathological response rate was 26.8%. In the cisplatin-treatment arm, the overall pathological response rate was 71.6% and the complete pathological response rate was 24.7%. There was no statistical difference in the two arms in survival or progression-free survival. Cisplatin was more nephrotoxic while carboplatin induced a higher degree of myelosuppression, especially thrombocytopenia; however, severe hematological toxicity was seldom observed. Carboplatin is a cisplatin analog with definite activity in ovarian cancer, but it is not more active than the parent compound. Because of less nonhematological toxicity, carboplatin is undoubtedly a useful substitute in patients who cannot be given cisplatin. Further experience is needed to indicate whether or not carboplatin should completely displace cisplatin in the clinical treatment of ovarian cancer. [J Natl Cancer Inst 81: 1464–1471, 1989]



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