title: A single-arm confirmatory study of amrubicin therapy in patients with refractory small-cell lung cancer: Japan Clinical Oncology Group Study (JCOG0901).
abstract: OBJECTIVE
  We conducted an open-label, multicenter, single-arm study to confirm the efficacy and safety of amrubicin (AMR), a topoisomerase II inhibitor, for treating refractory small-cell lung cancer (SCLC).
  
  
  METHODS
  Patients with chemotherapy-refractory SCLC received 40 mg/m(2) AMR for 3 consecutive days, every 21 days. The primary endpoint was the overall response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
  
  
  RESULTS
  Between November 2009 and February 2011, 82 patients were enrolled. Each patient received a median of four treatment cycles (range, 1-22 cycles). ORR was 32.9% [P<0.0001 by the exact binomial test for the null hypothesis that ORR ≤ 10%; 95% confidence interval (CI), 22.9-44.2%]. The median PFS and OS periods were 3.5 months (95% CI, 3.0-4.3 months) and 8.9 months (95% CI, 7.6-11.3 months), respectively. Significant differences in ORR (21.4% v 45.0%; P=0.034), PFS (median, 2.9 v 5.1 months; P=0.0009), and OS (median, 7.9 v 13.1 months; P=0.0128) were observed between patients previously treated with etoposide and others. Neutropenia was the most common grade 3 or 4 adverse events (93.9%), and febrile neutropenia developed in 26.8% patients. No treatment-related death occurred.
  
  
  CONCLUSIONS
  AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC. Previous chemotherapy with etoposide may influence AMR efficacy.
authors: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan. Electronic address: ha.murakami@scchr.jp.
authors: Haruyasu
authors: H
authors: Murakami
authors: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama 641-8509, Japan.
authors: Nobuyuki
authors: N
authors: Yamamoto
authors: Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo 104-0045, Japan.
authors: Taro
authors: T
authors: Shibata
authors: Department of Clinical Oncology, Osaka City General Hospital, Osaka 534-0021, Japan.
authors: Koji
authors: K
authors: Takeda
authors: Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan.
authors: Yukito
authors: Y
authors: Ichinose
authors: Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba 277-8577, Japan.
authors: Yuichiro
authors: Y
authors: Ohe
authors: Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
authors: Noboru
authors: N
authors: Yamamoto
authors: Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
authors: Yuichiro
authors: Y
authors: Takeda
authors: Department of Respiratory Medicine, Osaka City University Hospital, Osaka 545-8586, Japan.
authors: Shinzoh
authors: S
authors: Kudoh
authors: Department of Thoracic Oncology, Kinki-Chuo Chest Medical Center, Osaka 591-8555, Japan.
authors: Shinji
authors: S
authors: Atagi
authors: Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo 673-8558, Japan.
authors: Miyako
authors: M
authors: Satouchi
authors: Department of Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan.
authors: Katsuyuki
authors: K
authors: Kiura
authors: Department of Thoracic Oncology, Shikoku Cancer Center, Ehime 791-0280, Japan.
authors: Naoyuki
authors: N
authors: Nogami
authors: Division of Diagnostic Radiology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan.
authors: Masahiro
authors: M
authors: Endo
authors: Division of Diagnostic Radiology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
authors: Hirokazu
authors: H
authors: Watanabe
authors: Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
authors: Tomohide
authors: T
authors: Tamura
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*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin
keywords: Amrubicin; Chemotherapy; Etoposide; Phase II; Refractory; Small-cell lung cancer