title: A phase II study of amrubicin as a third-line or fourth-line chemotherapy for patients with non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 0901.
abstract: Amrubicin, a third-generation synthetic anthracycline agent, has favorable clinical activity and acceptable toxicity for the treatment of patients with non-small cell lung cancer (NSCLC) and small cell lung cancer. We conducted this study to evaluate the efficacy and safety of amrubicin for advanced NSCLC patients as a third- or fourth-line therapy. Eligible patients had recurrent or refractory advanced NSCLC after second- or third-line therapy. Patients received amrubicin, 35 mg/m(2) i.v. on days 1-3 every 3 weeks. The primary endpoint was the disease control rate (DCR). Secondary endpoints were the overall survival (OS) time, progression-free survival (PFS) time, response rate, and toxicity profile. Of the 41 patients enrolled, 26 received amrubicin as a third-line and 15 received it as a fourth-line therapy. The median number of treatment cycles was two (range, 1-9). Objective responses were complete response (n = 0), partial response (n = 4), stable disease (n = 21), progressive disease (n = 15), and not evaluable (n = 1), resulting in a DCR of 61.0% (95% confidence interval, 46.0%-75.9%). The overall response rate was 9.8% (95% confidence interval, 0.6%-18.8%). The median PFS interval was 3.0 months, median OS time was 12.6 months, and 1-year survival rate was 53.7%. Grade 3 or 4 hematological toxicities were neutropenia (68%), anemia (12%), thrombocytopenia (12%), and febrile neutropenia (17%). Nonhematological toxicities were mild and reversible. No treatment-related deaths were observed. Amrubicin showed significant clinical activity with manageable toxicities as a third- or fourth-line therapy for patients with advanced NSCLC. This study provides relevant data for routine practice and future prospective trials evaluating third- or fourth-line treatment strategies for patients with advanced NSCLC.
authors: Center for Respiratory Disease, Hokkaido Social Insurance Hospital, Sapporo, Japan. t-harada@hok-shaho-hsp.jp
authors: Toshiyuki
authors: T
authors: Harada
authors: Satoshi
authors: S
authors: Oizumi
authors: Kenichiro
authors: K
authors: Ito
authors: Kei
authors: K
authors: Takamura
authors: Eiki
authors: E
authors: Kikuchi
authors: Tomoya
authors: T
authors: Kuda
authors: Shunichi
authors: S
authors: Sugawara
authors: Aya
authors: A
authors: Suzuki
authors: Makoto
authors: M
authors: Maemondo
authors: Yuka
authors: Y
authors: Fujita
authors: Ichiro
authors: I
authors: Kinoshita
authors: Akira
authors: A
authors: Inoue
authors: Fumihiro
authors: F
authors: Hommura
authors: Yutaka
authors: Y
authors: Katsuura
authors: Hirotoshi
authors: H
authors: Dosaka-Akita
authors: Hiroshi
authors: H
authors: Isobe
authors: Masaharu
authors: M
authors: Nishimura
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging
chemical_list: D018943:Anthracyclines; C055866:amrubicin