Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group

Purpose. A multicenter study was conducted to evaluate the activity and toxicity of gemcitabine in patients with previously treated nonsquamous cell carcinoma of the uterine cervix. Patients and methods. Eligible patients were required to have measurable disease with a GOG performance status of 0-2 and adequate bone marrow, renal, and hepatic function. Histologic confirmation of the primary diagnosis was mandatory. Patients were required to have received one prior chemotherapy regimen for metastatic, persistent or recurrent disease. The initial dosage of gemcitabine was 800 mg/m(2) weekly times three with 1 week off until progressive disease or adverse side effects prohibited further therapy. Doses were escalated or reduced based on the disease toxicity experiences during the previous cycle. Results. Twenty-two women were entered into the trial. Three patients did not complete follow-up assessment for tumor response leaving 19 evaluable patients for response. All 22 patients were evaluable for toxicity. A median of two cycles was administered to each patient (range: 1-8). The overall response rate (1 partial response) was 4.5% with 36.4% of patients having stable disease. The median progression-free interval was 2.1 months (range: 0.5-12.7) and the overall survival was 6.5 months (range: 0.6-21.9). One patient had a grade 4 gastrointestinal adverse event (rectovaginal fistula formation attributed to the underlying cancer and not the study agent) complicated by grade 4 metabolic derangement. There were no grade 4 hematologic toxicities or treatment-related deaths. Conclusions. Gemcitabine as a single agent had minimal activity in previously treated patients with non-squamous cell carcinoma of the uterine cervix. (C) 2004 Elsevier Inc. All rights reserved.