title: Phase II study of 3-week scheduling of irinotecan in combination with cisplatin in patients with advanced nonsmall-cell lung cancer.
abstract: OBJECTIVE
  The combination of irinotecan and cisplatin given every 4 weeks is one of the standard treatments for advanced nonsmall-cell lung cancer (NSCLC) in Japan. The purpose of this study is to evaluate the efficacy, safety and dose-intensity as a measure of the feasibility of 3-week scheduling of irinotecan and cisplatin in patients with advanced NSCLC in phase II study.
  
  
  METHODS
  Previously untreated patients with stage IIIB and IV NSCLC were treated intravenously with irinotecan (60 mg/m2) on days 1 and 8 and cisplatin (60 mg/m2) on day 1 of a 3-week cycle.
  
  
  RESULTS
  Of the 28 patients enrolled, 27 were evaluable for response and toxicity. The response rate was 30% (95% confidence interval, 14-50%). The median duration of response was 16 weeks (range, 10-26 weeks). The median survival time for all patients was 52 weeks and the 1-year and 2-year survival rates were 48% and 29%, respectively. The dose-intensity of irinotecan was 34 mg/m2/wk (range, 19-40). The major toxicities observed were neutropenia (grade 3, 30%; 4, 30%), leukopenia (grade 3, 30%), and diarrhea (grade 3, 22%). Other toxicities were generally mild.
  
  
  CONCLUSIONS
  Three-week scheduling of irinotecan and cisplatin is effective and feasible in advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki, Japan. hsaito@sun-inet.or.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Shinzoh
authors.initials: S
authors.lastname: Kudoh
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Semba
authors.forename: Minoru
authors.initials: M
authors.lastname: Takada
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin