Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix

Purpose: To evaluate the activity and toxicity af the combination of cispla tin (80 mg/m(2) day 1) and vinorelbine (25 mg/m(2) days 1 and 8) in patient s with carcinoma of the uterine cervix that hers not been previously treate d with chemotherapy. Patients and Methods: Fifty patients with cervical cancer were enrolled ont o this study (27 stage IB-III, 23 stage NB-recurrent). A two-stage optimal Simon design was applied. Thirteen responders of 29 treated patients were r equired to proceed beyond the first stage, and 28 responders were needed ov erall. Results: Hematologic toxicity was mild, with neutropenia being the most fre quent side effect. Nonhematologic toxicity was frequent but never severe; o ne patient herd grade 3 peripheral neurotoxicity. Objective responses were recorded for 32 patients (64%): 11 patients (22%) achieved a complete respo nse (CR) and 21 patients (42%) achieved a partial response (PR). The respon se rate was 81.5% in patients with IB-III stage (25.9% CR rate) and 43.5% i n patients with IVB-recurrent disease (17.4% CR rate). Responses were seen both in stage IVB patients (one CR acid two PRs, for an overall rate of 37. 5%) and in patients with recurrent disease (three CRs + four PRs, for an ov erall rate of 46.7%). Conclusion: The combination of cisplatin and vinorelbine is an active regim en in the treatment of patients with early-stage and advanced carcinoma of the uterine cervix. The hematologic and nonhematologic toxicity of this com bination is mild. (C) 1999 by American Society of Clinical Oncology.