Phase II study of irinotecan and cisplatin as first-line chemotherapy in advanced or recurrent cervical cancer

Irinotecan (CPT-11) and cisplatin are singly active against cervical cancer . We evaluated the efficacy and toxicity of CPT-11 plus cisplatin as first- line chemotherapy in patients with advanced or recurrent cervical cancer. T wenty-nine chemotherapy-naive patients with advanced or recurrent cervical cancer were treated with CPT-11 (60 mg/m(2)) on days 1, 8, and 15 by intrav enous infusion over 90 min, followed by cisplatin (60 mg/m(2) i.v.) on day 1 over 90 min. The patients' median age was 57 years (range 35-75). Ninetee n patients (66%) had advanced primary disease. Six patients with recurrent disease (21%) had been treated with prior radiotherapy. The remaining 4 pat ients (14%) had residual or recurrent disease after radical surgery. The hi stologic diagnoses were squamous cell carcinoma in 25 patients (87%), adeno carcinoma in 3, and adenosquamous cell carcinoma in 1. A ll eligible patien ts were included in the toxicity and response analysis based on the intent to treat. Two patients (7%) achieved a complete response and 15(52%) a part ial response (overall response rate: 59%, 95% confidence interval; 41-74%). Stable disease was recorded in 6 patients (21%) and progressive disease in 3 patients (10%). In 3 patients, image-guided evaluation of response was j udged to be unfeasible at the time of independent extramural review (10%). The median time to response was 32 days (range 16-62 days). The median surv ival was 27.7+ months (range, 6.4-52.8+ months). Two dose-limiting side eff ects were observed: grade 3 (28%) or 4 (45%) neutropenia and grade 3 (7%) o r 4 (7%) diarrhea. Other severe toxicities included anemia (45%), thrombocy topenia (3%), nausea/vomiting (31%), and alopecia (7%). The combination of CPT-11 with cisplatin is an active regimen for treatment of advanced or rec urrent cervical cancer albeit with a significant degree of myelosuppression . Copyright (C) 2000 S. Karger AG, Basel.