Luigi Frigerio

JClin Oncol 15:1938-1944. (c) 1997 by American Society of Clinical Oncology.
(In Coll. con Giorgio Boils, Giuseppe Favalli, Saverio Danese, Flavia Zanaboni, Giorgia Mangili, Claudio Scarabelli, Saveria Tatea, Maria Grazia Valsecchi, GiovannaScarfone, GiovanniRichiardi, Mauro Melpignano, Antonella Villa, Fabio Parazzini)
Purpose To compare the efficacy of a treatment with cisplatin plus cyclophosphamide given for 5 months and a short treatment with cisplatin alone in advanced ovarian cancer, we conducted a multicenter randomized clinical trial.
Patients and Methods: Eligibility criteria were as follows: first diagnosis of histologically confirmed invasive epithelial ovarian cancer of International Federation of Gynecology and Obstetric (FIGO) stage IIl-IV, age younger than 75 years, and Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Within 28 days of cytoreductive surgery, eligible women were randomly assigned treatment with weekly cisplatin 50 mg/m2 for nine courses or cisplatin 75 mglm2 plus cyclophosphamide 750 mg/m2 every 21 days for six courses.
Results: A total of 607 women were entered onto the study. There was no difference in the response to treatment. Pathologic complete response (CR) was documented in 63 of the weekly cisplatin cases and 70 of the cisplatin plus cyclophosphamide group (x2 = 1.43; P = .23). The median follow-up time was 3 years. There were 151 and 148 deaths in the weekly cisplatin and cyclophosphamide plus cisplatin arms, respectively. Survival curves were similar in the two groups, with a 3-year percent survival estimate of 44.1 (SE = 3.4) in the weekly cisplatin and 44.6 (SE = 3.4) in the cisplatin plus cyclophosphamide group (log-rank test x2 = 0.004; P = .96).
Conclusion: This study found that 2-month mono- chemotherapy treatment with cisplatin was as effective as 5-month polychemotherapy including cisplatin at a similar doses but different dose-intensity plus cyclophosphamide.