title: Phase II study of sequential triplet chemotherapy, irinotecan and cisplatin followed by amrubicin, in patients with extensive-stage small cell lung cancer: West Japan Thoracic Oncology Group Study 0301.
abstract: BACKGROUND
  Combination chemotherapy of irinotecan, a topoisomerase I inhibitor, and cisplatin is a standard treatment in patients with extensive-stage small cell lung cancer (SCLC). Amrubicin, a novel 9-aminoanthracycline, inhibits topoisomerase II. We investigated a sequential triplet chemotherapy consisting of irinotecan and cisplatin followed by amrubicin in patients with extensive-stage SCLC.
  
  
  METHODS
  Eligible patients were aged 20 to 70 years and had Eastern Cooperative Oncology Group performance status of 0 or 1, measurable lesions, and adequate organ functions. Chemotherapy consisted of irinotecan 60 mg/m on days 1 and 8 plus cisplatin 60 mg/m on day 1 every 3 weeks for three cycles and then amrubicin 40 mg/m alone on days 1 to 3 every 3 weeks for three cycles.
  
  
  RESULTS
  From September 2004 to September 2006, 45 patients were enrolled, 43 were evaluable for response and survival, and 44 were evaluable for toxicity. Twenty-eight patients (64%) completed the full planned chemotherapy. One patient achieved complete response and 33 had partial response for an overall response rate of 79%. Median progression-free survival was 6.5 months. Median overall survival was 15.4 months. Major toxicity was myelosuppression. Grade 3 or 4 neutropenia, anemia, thrombocytopenia, and febrile neutropenia occurred in 57%, 7%, 0%, and 7% of patients during irinotecan/cisplatin cycles and in 91%, 27%, 9%, and 15% of patients during amrubicin cycles, respectively.
  
  
  CONCLUSIONS
  The sequential triplet chemotherapy, irinotecan and cisplatin followed by amrubicin, is an effective and well-tolerated treatment in patients with extensive-stage SCLC. Further investigation of this treatment is warranted.
authors.affiliation: Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan. kobayashima@opho.jp
authors.forename: Masashi
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Iwamoto
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Ebi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Oizumi
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sawa
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Shibata
authors.forename: Hideo
authors.initials: H
authors.lastname: Saka
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Seki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Isao
authors.initials: I
authors.lastname: Goto
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001932:Brain Neoplasms / Q000188:drug therapy / Q000556:secondary; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000077146:Irinotecan; C055866:amrubicin; D002945:Cisplatin; D002166:Camptothecin