title: Evaluation of the recommended dose and efficacy of amrubicin as second- and third-line chemotherapy for small cell lung cancer.
abstract: BACKGROUND
  This study was conducted to evaluate the recommended dose and activity of amrubicin (AMR) as second- or third-line chemotherapy for small-cell lung cancer (SCLC).
  
  
  METHODS
  Small-cell lung cancer patients with measurable disease who had previously been treated with at least one platinum-based chemotherapy regimen and had an Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Two groups of patients were selected: (1) a group to be treated with second-line chemotherapy and (2) a group to be treated with third-line chemotherapy. AMR was administered to both groups as a 5-minute daily intravenous injection at a dose of 40 or 35 mg/m2 for three consecutive days every 3 weeks.
  
  
  RESULTS
  Between March 2003 and June 2006, 27 patients (second-line, 40 mg/m2: 13 patients; third-line, 40 mg/m2: seven patients; and 35 mg/m2: seven patients) were enrolled. Although the 40-mg/m2 dose of AMR was feasible (one of 13 patients developed febrile neutropenia and four of 13 patients had grade 4 neutropenia) and effective (six of 13 patients had a partial response) in the second-line group, it produced unacceptable toxicity in a third-line setting (three of seven patients with grade 3 nonhematologic toxicities [febrile neutropenia in two patients and fatigue in one patient] and four of seven patients with grade 4 neutropenia). The 35-mg/m2 dose of AMR had acceptable toxicity in the third-line group (one of seven patients with febrile neutropenia and one of seven had grade 4 neutropenia) and moderate efficacy (one of seven patients had a partial response and two of seven had stable disease).
  
  
  CONCLUSIONS
  AMR exhibits significant activity as second-line or third-line chemotherapy for small-cell lung cancer. The recommended dose is 40 mg/m2 in a second-line setting and 35 mg/m2 in a third-line setting.
authors.affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Igawa
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Shinya
authors.initials: S
authors.lastname: Ueda
authors.forename: Akira
authors.initials: A
authors.lastname: Ono
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Asuka
authors.initials: A
authors.lastname: Tsuya
authors.forename: Haruyasu
authors.initials: H
authors.lastname: Murakami
authors.forename: Masahiro
authors.initials: M
authors.lastname: Endo
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Takahashi
mesh_terms: D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010166:Palliative Care; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C055866:amrubicin