PHASE-II STUDY OF PROLONGED ORAL ETOPOSIDE IN ADVANCED OR RECURRENT CARCINOMA OF THE CERVIX

Objective. To evaluate the efficacy and toxicity of prolonged oral eto poside as single agent chemotherapy in patients with advanced or recur rent carcinoma of the cervix. Methods. Between May 1991 and February 1 993, 44 patients with advanced or recurrent carcinoma of the cervix we re entered onto this study. Patients were eligible if they had receive d no more than two prior cytotoxic regimens. The initial dose of etopo side was 37.5 mg/m(2) administered orally on a daily basis on days 1-2 1 of a 28-day cycle, Subsequent doses were unchanged, reduced, escalat ed, or omitted according to toxicity. Patients were evaluated for resp onse and toxicity using standard Gynecologic Oncology Group criteria. Results. Forty-four patients were evaluable for response and toxicity. The overall response rate was 9.1% (2 CR, 2 PR). In patients with no prior chemotherapy the response rate was 4/25 compared to 0/19 for tho se who had prior therapy. The mean response duration was 2.7 months an d the median survival from treatment for all patients was 7.7 months. The major toxicity was granulocytopenia, with 11% of patients having g rade 3 or 4 toxicity. Gastrointestinal toxicity of some degree occurre d in 11% of patients, and alopecia was universal. Conclusion. Prolonge d oral etoposide has limited activity in advanced or recurrent carcino ma of the cervix. Its use as palliative therapy for this disease is no t indicated. (C) 1998 Academic Press.