WEEKLY CISPLATIN GIVEN FOR 2 MONTHS VERSUS CISPLATIN PLUS CYCLOPHOSPHAMIDE GIVEN FOR 5 MONTHS AFTER CYTOREDUCTIVE SURGERY FOR ADVANCED OVARIAN-CANCER

Purpose: To compare the efficacy of a treatment with cisplatin plus cy clophosphamide given for 5 months and a short treatment with cisplatin alone in advanced ovarian cancer, we conducted a multicenter randomiz ed clinical trial. Patients and Methods: Eligibility criteria were as follows: first diagnosis of histologically confirmed invasive epitheli al ovarian cancer of International Federation of Gynecology and Obstet ric (FIGO) stage Ill-IV, age younger than 75 years, and Eastern Cooper ative Oncology Group (ECOG) performance status 0, 1, or 2. Within 28 d ays of cytoreductive surgery, eligible women were randomly assigned tr eatment with weekly cisplatin 50 mg/m(2) for nine courses or cisplatin 75 mg/m(2) plus cyclophosphamide 750 mg/m(2) every 21 days for six co urses. Results: A total of 607 women were entered onto the study, Ther e was no difference in the response to treatment. Pathologic complete response (CR) was documented in 63 of the weekly cisplatin cases and 7 0 of the cisplatin plus cyclophosphamide group (chi(1)(2) = 1.43; P = .23). The median follow-up time was 3 years. There were 151 and 148 de aths 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 cisp latin and 44.6 (SE = 3.4) in the cisplatin plus cyclophosphamide group (log-rank test chi(1)(2) = 0.004; P = .96). Conclusion: This study fo und that 5-month monochemotherapy treatment with cisplatin wets as eff ective as 5-month polychemotherapy including cisplatin at a similar do ses but different dose-intensity plus cyclophosphamide. (C) 1997 by Am erican Society of Clinical Oncology.