RESUMO
BACKGROUND: This phase II trial was performed to assess the activity and safety of the cisplatin and vinorelbine combination in patients with advanced cervical carcinoma. PATIENTS AND METHODS: Forty-two patients with advanced cervical cancer were included in the study to receive vinorelbine at 30 mg/m2 on d 1 and d 8 and cisplatin 100 mg/m2 on day 1 every 4 weeks. RESULTS: Thirty-seven patients were evaluable for response and 40 patients for tolerance. Twenty-four patients (64.8%) achieved objective responses. The median duration of response was 17.5 months (range 2.5-57 months), median time to progression was 13.2 months (range 0.4-57 months) and median survival was 20.6 months (range 0.4-55 months). This regimen was well-tolerated; no WHO grade 4 neutropenia was observed, grade 3 nausea and vomiting occured in 50% of patients and grade 2 peripheral neuropathy in 5% of patients. CONCLUSION: Vinorelbine-cisplatin is an active and well-tolerated regimen in advanced cervical carcinoma.