title: Phase II trial of amrubicin for treatment of refractory or relapsed small-cell lung cancer: Thoracic Oncology Research Group Study 0301.
abstract: OBJECTIVE
  This multicenter, phase II study was conducted to evaluate the activity of amrubicin, a topoisomerase II inhibitor, against refractory or relapsed small-cell lung cancer (SCLC).
  
  
  METHODS
  SCLC patients with measurable disease who had been treated previously with at least one platinum-based chemotherapy regimen and had an Eastern Cooperative Oncology Group performance status of 0 to 2 were eligible. Two groups of patients were selected: patients who experienced first-line treatment failure less than 60 days from treatment discontinuation (refractory group), and patients who responded to first-line treatment and experienced disease progression > or = 60 days after treatment discontinuation (sensitive group). Amrubicin was administered as a 5-minute daily intravenous injection at a dose of 40 mg/m2 for 3 consecutive days, every 3 weeks.
  
  
  RESULTS
  Between June 2003 and December 2004, 60 patients (16 refractory and 44 sensitive) were enrolled. The median number of treatment cycles was four (range, one to eight). Grade 3 or 4 hematologic toxicities comprised neutropenia (83%), thrombocytopenia (20%), and anemia (33%). Febrile neutropenia was observed in three patients (5%). Nonhematologic toxicities were mild. No treatment-related death was observed. The overall response rates were 50% (95% CI, 25% to 75%) in the refractory group, and 52% (95% CI, 37% to 68%) in the sensitive group. The progression-free survival, overall survival, and 1-year survival in the refractory group and the sensitive group were 2.6 and 4.2 months, 10.3 and 11.6 months, and 40% and 46%, respectively.
  
  
  CONCLUSIONS
  Amrubicin exhibits significant activity against SCLC, with predictable and manageable toxicities; this agent deserves to be studied more extensively in additional trials.
authors.affiliation: Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Sayaka
authors.initials: S
authors.lastname: Onoda
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Masuda
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takiguchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Isobe
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogura
authors.forename: Akira
authors.initials: A
authors.lastname: Yokoyama
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Seki
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Asaka-Amano
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tagawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kunikane
authors.forename: Masanori
authors.initials: M
authors.lastname: Yokoba
authors.forename: Kazutsugu
authors.initials: K
authors.lastname: Uematsu
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kuriyama
authors.forename: Yumi
authors.initials: Y
authors.lastname: Kuroiwa
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
mesh_terms: D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000628:therapy*; D010166:Palliative Care; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin