PHASE-II STUDY OF VINORELBINE IN ADVANCED AND RECURRENT SQUAMOUS-CELLCARCINOMA OF THE CERVIX

Purpose: To evaluate the efficacy and toxicity of intravenous vinorelb ine as single-agent chemotherapy in patients with advanced or recurren t squamous cell carcinoma of the cervix. Patients and Methods: Between August 1993 and July 1995, 35 patients with advanced or recurrent squ amous cell carcinoma of the cervix were entered onto this study. Patie nts had received no prior therapeutic chemotherapy. The initial dose o f vinorelbine 30 mg/m(2) was administered as a weekly intravenous infu sion. Subsequent doses were unchanged, reduced, escalated, or omitted according to observed toxicity. Patients were evaluated for response a nd toxicity using standard Gynecologic Oncology Group (GOG) and World Health Organization criteria, respectively. Results: Thirty-three of 3 5 patients were assessable for response and 35 of 35 for toxicity. The overall response rate was 18% (one complete response [CR], five parti al responses [PR]). The mean response duration was 5.2 months and the median survival from treatment for all patients was 11.0 months. The m ajor toxicity was leukopenia, with 61% of patients who had grade 3 or 4. Gastrointestinal and neurotoxicity were infrequent and mild. Conclu sion: Vinorelbine has moderate activity in advanced or recurrent squam ous cell carcinoma of the cervix. Further studies of combination regim ens with this agent are justified in this patient population. (C) 1998 by American Society of Clinical Oncology.