title: Phase II study of irinotecan and cisplatin as first-line chemotherapy in advanced or recurrent cervical cancer.
abstract: 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. Twenty-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 intravenous 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). Nineteen patients (66%) had advanced primary disease. Six patients with recurrent disease (21%) had been treated with prior radiotherapy. The remaining 4 patients (14%) had residual or recurrent disease after radical surgery. The histologic diagnoses were squamous cell carcinoma in 25 patients (87%), adenocarcinoma in 3, and adenosquamous cell carcinoma in 1. All eligible patients 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 partial 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 judged 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 survival was 27. 7+ months (range, 6.4-52.8+ months). Two dose-limiting side effects were observed: grade 3 (28%) or 4 (45%) neutropenia and grade 3 (7%) or 4 (7%) diarrhea. Other severe toxicities included anemia (45%), thrombocytopenia (3%), nausea/vomiting (31%), and alopecia (7%). The combination of CPT-11 with cisplatin is an active regimen for treatment of advanced or recurrent cervical cancer albeit with a significant degree of myelosuppression.
authors.affiliation: Department of Obstetrics and Gynecology, Kurume University, Kurume, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Sugiyama
authors.forename: M
authors.initials: M
authors.lastname: Yakushiji
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: M
authors.initials: M
authors.lastname: Ikeda
authors.forename: R
authors.initials: R
authors.lastname: Kudoh
authors.forename: A
authors.initials: A
authors.lastname: Yajima
authors.forename: Y
authors.initials: Y
authors.lastname: Tomoda
authors.forename: Y
authors.initials: Y
authors.lastname: Terashima
authors.forename: S
authors.initials: S
authors.lastname: Takeuchi
authors.forename: M
authors.initials: M
authors.lastname: Hiura
authors.forename: F
authors.initials: F
authors.lastname: Saji
authors.forename: T
authors.initials: T
authors.lastname: Takahashi
authors.forename: N
authors.initials: N
authors.lastname: Umesaki
authors.forename: S
authors.initials: S
authors.lastname: Sato
authors.forename: M
authors.initials: M
authors.lastname: Hatae
authors.forename: Y
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002277:Carcinoma / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D059004:Topoisomerase I Inhibitors; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D059004:Topoisomerase I Inhibitors; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin