title: Phase II study of amrubicin at a dose of 45 mg/m2 in patients with previously treated small-cell lung cancer.
abstract: OBJECTIVE
  Most of the previous studies of amrubicin in patients with previously treated small-cell lung cancer were conducted at a dose of 40 mg/m(2). The aim of this study was to assess the efficacy and safety of amrubicin at a dose of 45 mg/m(2) in patients with relapsed or refractory small-cell lung cancer.
  
  
  METHODS
  Previously treated small-cell lung cancer patients were eligible. Amrubicin at a dose of 45 mg/m(2) was administered on Days 1-3 every 3 weeks. The primary endpoint was the response rate.
  
  
  RESULTS
  From June 2003 to January 2005, 35 patients were enrolled, of whom 34 received this study treatment. Four cycles or more could be administered in 21 patients (62%). Dose reduction was required in 15 (52%) of the 29 patients who had received two cycles or more. Three complete responses and 15 partial responses were observed among the 34 treated patients, yielding a response rate of 53% (95% confidence interval, 35-71%). Median progression-free survival of the patients was 4.4 months (95% confidence interval, 2.4-5.1 months). Median survival time was 8.2 months (95% confidence interval, 6.6-10.0 months) and 1-year survival rate was 24% (95% confidence interval, 9-39%). Grade 3/4 leukopenia, neutropenia and thrombocytopenia were observed in 76, 97 and 38% of the patients, respectively. Febrile neutropenia occurred in 12 patients (35%), and one patient died from pneumonia.
  
  
  CONCLUSIONS
  While amrubicin at a dose of 45 mg/m(2) showed high response rate for both sensitive and refractory relapse, the incidence of febrile neutropenia was also high. The utility of amrubicin at 45 mg/m(2) might accordingly be limited.
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Tetsuhiko
authors.initials: T
authors.lastname: Asao
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Yoh
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Seiji
authors.initials: S
authors.lastname: Niho
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Koichi
authors.initials: K
authors.lastname: Goto
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Ohmatsu
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo Department of Medical Oncology, Faculty of Medicine, University of Tsukuba, Tsukuba.
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo Division of Chemotherapy, Department of Internal Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Kunitoh
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo yutakafu@ncc.go.jp.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009503:Neutropenia / Q000209:etiology; D011014:Pneumonia / Q000209:etiology; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D015996:Survival Rate; D013921:Thrombocytopenia / Q000209:etiology; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin
keywords: Phase II; amrubicin; salvage chemotherapy; small-cell lung cancer