title: Multicenter phase 2 study of belotecan, a new camptothecin analog, and cisplatin for chemotherapy-naive patients with extensive-disease small cell lung cancer.
abstract: BACKGROUND
  The objective of this study was to investigate the efficacy of belotecan, a new camptothecin analog, combined with cisplatin for the treatment of chemotherapy-naive patients with extensive-disease small cell lung cancer (ED SCLC).
  
  
  METHODS
  Treatment consisted of belotecan 0.5 mg/m(2) daily on Days 1 through 4 and cisplatin 60 mg/m(2) on Day 1 of a 3-week cycle for up to 6 cycles unless there was disease progression, unacceptable toxicity, or patient refusal. Response assessment was done every 2 cycles using the Response Evaluation Criteria in Solid Tumors, and toxicity assessment was done every cycle using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
  
  
  RESULTS
  Between September 2006 and March 2008, 30 patients participated in the study. Among them, 21 patients achieved a partial response, and the response rate was 70% (95% confidence interval [CI], 50.6%-85.3%); and, after a median follow-up of 20.2 months, the median progression-free survival was 6.9 months (95% CI, 6.3-7.5 months), and the overall survival was 19.2 months (95% CI, 13.3-25.2 months). Grade 3 and 4 adverse events included neutropenia in 23 patients, thrombocytopenia in 8 patients, febrile neutropenia in 9 patients, nausea in 3 patients, and pneumonia in 3 patients. There was 1 treatment-related death from pneumonia. However, nonhematologic toxicity generally was mild and manageable.
  
  
  CONCLUSIONS
  The belotecan and cisplatin combination that was studied demonstrated promising response rates and survival outcomes with a manageable toxicity profile for chemotherapy-naive patients who had ED SCLC. The authors concluded that the combination warrants further randomized trials.
authors.affiliation: Department of Oncology, Asan Medical Center, University of UIsan College of Medicine, Seoul, Korea.
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Sang-We
authors.initials: SW
authors.lastname: Kim
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.forename: Jung-Shin
authors.initials: JS
authors.lastname: Lee
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.forename: Im-Il
authors.initials: II
authors.lastname: Na
authors.forename: Jae Cheol
authors.initials: JC
authors.lastname: Lee
authors.forename: Baek-Yeol
authors.initials: BY
authors.lastname: Ryoo
authors.forename: Sung Hyun
authors.initials: SH
authors.lastname: Yang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality
chemical_list: C116963:belotecan; D002945:Cisplatin; D002166:Camptothecin