RANDOMIZED STUDY COMPARING CARBOPLATIN CYCLOPHOSPHAMIDE AND CISPLATIN/CYCLOPHOSPHAMIDE AS FIRST-LINE TREATMENT IN PATIENTS WITH STAGE III/IV EPITHELIAL OVARIAN-CANCER AND SMALL-VOLUME DISEASE/

Several randomized studies in patients with advanced ovarian cancer ha ve dealt with the comparison of cisplatin and carboplatin when given a s either a single drug or in combination. The German Ovarian Cancer St udy Group (GOCA) performed a prospective randomized trial in a subgrou p of patients specified by a successful cytoreductive operation before the start of chemotherapy. From February 1987 to May 1990, 173 previo usly untreated patients with stage III and IV disease and Limited tumo r bulk of < 2 cm postoperatively received either cyclophosphamide 600 mg/m(2) plus carboplatin 350 mg/m(2) or cyclophosphamide 1000 mg/m(2) plus cisplatin 80 mg/m(2). The drugs had to be administered on Day 1 e very 28 days for six subsequent courses. Results. In 158 assessable pa tients no significant differences in pathologically confirmed CR rates (pCR: 14% vs 16%), median time to progression (PFI: 19 months vs 26 m onths), and overall survival (OS: 35 months vs 37 months) were observe d. Refusal of therapy due to toxicity was more frequent in the cisplat in arm, whereas patients with progressive disease predominated in the carboplatin arm. Nonhematologic adverse effects were more likely to oc cur with cisplatin whereas carboplatin patients experienced more myelo suppression. As prognostic factors associated with an increased risk o f progressive disease and shorter overall survival time, stage of dise ase and amount of residual tumor after first surgery were determined. Conclusions. Carboplatin proved to be effective in patients with optim ally debulked ovarian cancer. However, neither regimen used in this tr ial is sufficiently active to prevent tumor progression in the majorit y of patients. (C) 1997 Academic Press.