title: A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Phase II trial JMTO LC02-02.
abstract: OBJECTIVE
  We conducted a Phase II study to evaluate the efficacy and safety of a weekly combination of carboplatin and irinotecan regimen for patients with extensive disease small-cell lung cancer.
  
  
  METHODS
  Patients with previously untreated extensive disease small-cell lung cancer, Eastern Cooperative Oncology Group performance status 0, 1 or 2, were enrolled in this trial. Carboplatin area under the curve of two and irinotecan (50 mg/m(2)) were administered on days 1 and 8 every 3 weeks. Treatment was continued up to a maximum of six cycles. The expected response rate was 85%, and this regimen was considered sufficiently positive if >45 responses were observed in the 55 patients.
  
  
  RESULTS
  Between December 2003 and September 2006, 56 patients were enrolled and 55 patients were eligible. Of 55 patients, 6 complete remissions and 37 partial remissions were achieved, and the response rate was 78.2% (95% confidence interval: 64.6-87.9). Major Grade 3 or more toxicities were leukocytopenia 3, neutropenia 15, anemia 7, infection 5, diarrhea 3, anorexia 7, nausea 6 and pneumothorax 1. The median survival was 13.9 months (95% confidence interval: 11.8-18.5) and the median progression-free survival was 5.7 months (95% confidence interval: 4.9-7.4).
  
  
  CONCLUSIONS
  This Phase II trial of a weekly combination of carboplatin and irinotecan for extensive disease small-cell lung cancer was not positive for a response rate that is considered to be worthy of further Phase III trial.
authors.affiliation: National Hospital Organization Kinki-chuo Chest Medical Center, 1180 Nagasone Kita-ku, Sakai-city, Osaka, Japan. okishio@kch.hosp.go.jp
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Okishio
authors.forename: Tadashi
authors.initials: T
authors.lastname: Mio
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawahara
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Takashi
authors.initials: T
authors.lastname: Daimon
authors.forename: Kiyoyuki
authors.initials: K
authors.lastname: Furuse
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin