A phase II study of carboplatin and cisplatin in advanced or recurrent squamous carcinoma of the uterine cervix.

Between March 1990 and July 1992, 42 women with squamous carcinoma of the uterine cervix were prospectively treated with carboplatin (260 mg/m2) on Day 1 and cisplatin (50 mg/m2) on Day 2 every 28 days. Patients had either stage IVb (FIGO) cancer (5 patients) or recurrent cancer (37 patients) and a Zubrod score < or = 2. Forty-one patients had received either radiation or surgery as primary therapy; 179 cycles of chemotherapy were delivered. The mean number of cycles administered to each patient was 4 (range, 2-8 cycles). Dose escalation was possible in 32 cycles (23.4%) and dose reduction was required in 10 cycles (7.3%). The dose-limiting toxic effect was myelosuppression, with grade 3-4 thrombocytopenia in 39 cycles (22%) and neutropenia in 19 cycles (11%). Neurotoxic effects were observed in 3 patients. Forty-two patients were evaluable for response: 1 had a complete response and 11 had a partial response (response rate 28.6%, 95% confidence interval, 14.9-42.3%). For all patients and for responders, median progression-free interval was 4.4 and 9.5 months, respectively, and median length of survival was 8.9 and 9.5 months, respectively. This regimen was well tolerated and had significant activity in the treatment of cervical cancer. Comparison to other platinum-based regimens in a Phase III trial should be considered.