title: Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial.
abstract: OBJECTIVE
  Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The patients were required to have cytologically or histologically proven measurable NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Amrubicin was administered by daily intravenous injection at 45 mg/m2/day for 3 consecutive days every 3 weeks. At least 3 cycles of treatment were administered to each patient.
  
  
  RESULTS
  All 61 patients registered in this trial were eligible and assessable for efficacy and toxicity. Of them, 17 patients achieved objective responses, consisting of one complete response and 16 partial responses, and the overall response rate was 27.9% (95% confidence interval [CI], 17.1% to 40.8%). The median survival time was 9.8 months (95% CI, 7.7 months to 14.9 months). The major toxicity was myelosuppression. The incidences of grade 3 or 4 toxicity were 72.1% for neutropenia, 52.5% for leukopenia, 23.0% for anemia, and 14.8% for thrombocytopenia. As noticeable toxic events, grade 3 hypotention and alkaline phosphatase elevation were transiently observed in one patient each. In addition, three patients who had had asymptomatic interstitial pneumonitis, identified by diagnostic imaging before treatment, aggravated after amrubicin treatment; two of them died. Other non-hematologic toxicities were relatively mild.
  
  
  CONCLUSIONS
  Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.
authors.affiliation: Division of Respiratory Medicine, Gifu Municipal Hospital.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Yana
authors.forename: Minoru
authors.initials: M
authors.lastname: Takada
authors.forename: Takahiko
authors.initials: T
authors.lastname: Sugiura
authors.forename: Shinzoh
authors.initials: S
authors.lastname: Kudoh
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kamei
authors.forename: Takeshi
authors.initials: T
authors.lastname: Isobe
authors.forename: Hidehiko
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Soichiro
authors.initials: S
authors.lastname: Yokota
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tohda
authors.forename: Akira
authors.initials: A
authors.lastname: Kawakami
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakanishi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ariyoshi
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin