IMPROVED THERAPEUTIC INDEX OF CARBOPLATIN PLUS CYCLOPHOSPHAMIDE VERSUS CISPLATIN PLUS CYCLOPHOSPHAMIDE - FINAL REPORT BY THE SOUTHWEST-ONCOLOGY-GROUP OF A PHASE-III RANDOMIZED TRIAL IN STAGE-III AND STAGE-IV OVARIAN-CANCER

Purpose: To compare cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide as primary chemotherapy for stage III (suboptimal) and stage IV ovarian cancer. Patients and Methods: Three hundred forty-two patients were randomly assigned to treatment with six courses of intravenous (IV) cisplatin 100 mg/m2 plus IV cyclophosphamide 600 mg/m2, or IV carboplatin 300 mg/m2 plus IVcyclophosphamide 600 mg/m2. Results: The estimated median survivals were 17.4 and 20.0 months for the cisplatin and carboplatin study arms, respectively. The null hypothesis of a 30% survival superiority with the cisplatin arm was refected at the P = .02 level. Clinical response rates were 52% for the cispla-tin arm and 61% for the carboplatin arm. Pathologic complete response rates were similar for both study arms. There was less thrombocytopenia on the cisplatin arm (P < .001); however, there was less nausea and emesis (P < .001 for courses 1 to 5), renal toxicity (P < .001), anemia (P = .01), hearing loss (P < .001), tinnitus (P = .01 ), neuromuscular toxicfties (P = .001), and alopecia (P < .001) on the carboplatin arm. Conclusion: Carboplatin-cyclophosphamide proved to have a significantly better therapeutic index than cisplafin-cyclophosphamide in patients with stage III (suboptimal) and stage IV ovarian cancer. © 1992 by American Society of Clinical Oncology.