© 1989 by Oxford University Press
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
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: 14641471, 1989]
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