title: A phase II study of amrubicin and carboplatin for previously untreated patients with extensive-disease small cell lung cancer.
abstract: BACKGROUND
  Amrubicin is active in the treatment of extensive-disease small cell lung cancer (ED-SCLC), and carboplatin is an analogue of cisplatin with less non-hematological toxicity.
  
  
  OBJECTIVE
  The purpose of this study was to determine the efficacy and toxicity of amrubicin and carboplatin combination chemotherapy for previously untreated patients with ED-SCLC.
  
  
  METHODS
  Eligibility criteria were chemotherapy-naïve ED-SCLC patients, performance status 0-1, age ≤75, and adequate hematological, hepatic and renal function. Based on the phase I study, the patients received amrubicin 35 mg/m(2) i.v. infusion on days 1, 2, and 3, and carboplatin AUC 5 i.v. infusion on day 1. Four cycles of chemotherapy were repeated every 3 weeks.
  
  
  RESULTS
  Thirty-five patients were enrolled, and 34 patients were eligible and assessable for response, toxicity, and survival. Patients' characteristics were as follows: male/female = 26/8; performance status 0/1 = 4/30; median age (range) = 64 (41-75); stage IV = 34. Evaluation of responses was 6 complete response, 21 partial response, and 7 stable disease (response rate 79.4 %, 95 % CI 63.6-88.5 %). Grade 3 and 4 leukopenia, neutropenia, and thrombocytopenia occurred in 59, 82, and 26 %, respectively. There were no treatment-related deaths or pneumonitis. Three patients experienced hypotension as an amrubicin infusion reaction. The median progression-free survival time was 6.5 months. The median overall survival time and 1-, 2-, and 3-year survival rates were 15.6 months, and 63, 28, and 7 %, respectively.
  
  
  CONCLUSIONS
  Amrubicin and carboplatin were effective and tolerable as chemotherapy for previously untreated patients with ED-SCLC. Further investigation of amrubicin and carboplatin is warranted.
authors.affiliation: Department of Medicine, Sasebo General Hospital, Nagasaki, Japan.
authors.forename: Takaya
authors.initials: T
authors.lastname: Ikeda
authors.forename: Minoru
authors.initials: M
authors.lastname: Fukuda
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Akitoshi
authors.initials: A
authors.lastname: Kinoshita
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Senju
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nakano
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kitazaki
authors.forename: Daiki
authors.initials: D
authors.lastname: Ogawara
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Kohei
authors.initials: K
authors.lastname: Motoshima
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Katsumi
authors.initials: K
authors.lastname: Nakatomi
authors.forename: Midori
authors.initials: M
authors.lastname: Shimada
authors.forename: Seiji
authors.initials: S
authors.lastname: Nagashima
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Tsukamoto
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kohno
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; C055866:amrubicin; D016190:Carboplatin