title: Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer.
abstract: To determine the efficacy and toxicity of irinotecan combined with carboplatin, we conducted a phase II trial. Eligibility criteria were: chemotherapy-naïve, small-cell lung cancer (SCLC), good performance status (PS: 0-2), age<or=75 years, and adequate organ function. The patients' characteristics were: male/female=56/5; PS 0/1/2=19/38/4; median age (range)=68 years(51-75 years); limited disease (LD)/extensive disease (ED)=27/34. The patients received irinotecan (50 mg m-2) on days 1, 8, and 15, and carboplatin (AUC 5, Chatelut formula) on day 1 every 4 weeks. In total, 61 patients were eligible and all were evaluated. In all, 31 patients were treated with four or more courses of chemotherapy. Of the patients, 17 showed a complete response (CR), 34 showed a partial response (PR), nine had stable disease (SD), and one had progressive disease (PD). The overall response rate was 84% (95% confidence interval (CI), 72-91%; LD 89%, ED 79%) and the CR rate was 28% (95%CI, 17-41%; LD 37%, ED 21%). The median time to tumour progression was 6.1 (LD 6.4, ED 5.4) months. The medial survival time was 15.0 (LD 20.0, ED 9.7) months, and the 2-year and 5-year survival rates were 31.1% (LD 48.1%, ED 17.7%) and 9.5% (LD 11.1%, ED 5.9%), respectively. Grade 3 or 4 leucopenia, neutropenia, thrombocytopenia, anaemia, and diarrhoea occurred in 33, 74, 41, 39, and 13% of cases, respectively. In conclusion, the combination of irinotecan and carboplatin is an active and well-tolerated regimen in cases of SCLC.
authors.affiliation: National Nagasaki Medical Center, Nagasaki, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Kinoshita
authors.forename: M
authors.initials: M
authors.lastname: Fukuda
authors.forename: H
authors.initials: H
authors.lastname: Soda
authors.forename: S
authors.initials: S
authors.lastname: Nagashima
authors.forename: M
authors.initials: M
authors.lastname: Fukuda
authors.forename: H
authors.initials: H
authors.lastname: Takatani
authors.forename: M
authors.initials: M
authors.lastname: Kuba
authors.forename: Y
authors.initials: Y
authors.lastname: Nakamura
authors.forename: J
authors.initials: J
authors.lastname: Tsurutani
authors.forename: S
authors.initials: S
authors.lastname: Kohno
authors.forename: M
authors.initials: M
authors.lastname: Oka
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin