title: Phase II study of topotecan with cisplatin in Japanese patients with small cell lung cancer.
abstract: BACKGROUND
  We conducted a phase II study of topotecan (Tp) with cisplatin (CDDP) in previously untreated Japanese patients with extensive-disease small cell lung cancer (ED-SCLC).
  
  
  METHODS
  In stage 1, a total of 30 patients were allocated to Tp 0.65 mg/m(2) with CDDP 60 mg/m(2) day 1 or Tp 1.00 mg/m(2) with CDDP day 5 following prophylactic granulocyte colony stimulating factor (G-CSF) from day 6. In stage 2, the selective combination in 29 patients was evaluated for response rate, toxicity and overall survival.
  
  
  RESULTS
  In stage 1, Tp 1.00 mg/m(2) with CDDP day 5 was selected this schedule had a better hematological profile. In stage 2, the response rate was 83%, and grade 3/4 adverse events were hematological-toxicities. The median survival time was 17.5 months and the 1 year survival rate was 79%.
  
  
  CONCLUSIONS
  Combination of Tp and CDDP on day 5 with G-CSF support is safe and effective for previously untreated ED-SCLC Japanese patients.
authors.affiliation: Division of Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan. yhosomi@cick.jp
authors.forename: Yukio
authors.initials: Y
authors.lastname: Hosomi
authors.forename: Masahiko
authors.initials: M
authors.lastname: Shibuya
authors.forename: Seiji
authors.initials: S
authors.lastname: Niho
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Shinzo
authors.initials: S
authors.lastname: Kudo
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Masuda
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ando
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D016019:Survival Analysis; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan; D002945:Cisplatin