1236P - Amrubicin (AMR) versus docetaxel (DTX) as second- or third-line treatment for non-small cell lung cancer (NSCLC): A randomized phase III trial

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Nobuyuki Katakami
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors N. Katakami1, H. Yoshioka2, H. Okamoto3, Y. Iwamoto4, T. Seto5, T. Takahashi6, N. Sunaga7, S. Kudoh8, K. Chikamori9, M. Harada10, H. Tanaka11, H. Saka12, K. Takeda13, N. Nogami14, N. Masuda15, T. Harada16, N. Yamamoto17, K. Nakagawa18
  • 1Division Of Integrated Oncology, Institute of Biomedical Research and Innovation, 650-0047 - Kobe/JP
  • 2Respiratory Medicine Dept., Kurashiki Central Hospital, 710-8602 - Kurashiki/JP
  • 3Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, JP-240-8555 - Yokohama/JP
  • 4Medical Oncology, Hiroshima city hospital, Hiroshima/JP
  • 5Department Of Thoracic Oncology, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 6Division Of Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 7Department Of Respiratory Disease, Gunma University Hospital, Maebashi/JP
  • 8Department Of Clinical Oncology, Osaka City University Hospital, 545-8585 - Osaka/JP
  • 9Respiratory Medicine, NHO Yamaguchi-Ube Medical Center, Ube/JP
  • 10Department Of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center, 0030804 - Sapporo/JP
  • 11Department Of Internal Medicine, Niigata Cancer Center Hospital, Niigata/JP
  • 12Medical Oncology & Respiratory Medicine, National Hospital Organization Nagoya Medical Center, 460-0001 - Nagoya/JP
  • 13Department Of Clinical Oncology, Osaka City General Hospital, 534-0021 - Osaka/JP
  • 14Dept Of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama/JP
  • 15Department Of Respiratory Medicine, Kitasato University School of Medicine, JP-252-0374 - Sagamihara/JP
  • 16Department Of Respiratory Disease, Hokkaido Social Insurance Hospital, Sapporo/JP
  • 17Third Department Of Internal Medicine, Wakayama Medical University, Wakayama/JP
  • 18Medical Oncology, Kinki University School of Medicine, JP-589-8511 - Osakasayama/JP



DTX is one of the standard drugs for patients (pts) with previously treated NSCLC. However, its efficacy seems insufficient. The efficacy of AMR for NSCLC has been previously reported. Thus, we conducted a randomized phase III trial comparing AMR to DTX, sponsored by Dainippon Sumitomo Pharma Co., Ltd.


We enrolled pts with NSCLC, Eastern Cooperative Oncology Group Performance Status 0-1, undergoing second- or third-line treatment, and aged 20–74 years. Pts were classified by histology, prior treatment, and institution into 2 groups and then randomly assigned (1:1 ratio) to treatment with AMR (35 mg/m2/day i.v., on days 1–3, q3w) or DTX (60 mg/m2/day i.v., on day 1, q3w). We planned a sample size of 100 patients per group, with a 2-sided alpha of 5% and power of 90%. We hypothesized a median progression-free survival (PFS) time of 3.3 and 2.0 months for AMR and DTX, respectively. The primary endpoint was PFS; secondary endpoints included overall survival (OS), overall response rate (ORR), disease control rate (DCR), and adverse events according to Common Terminology Criteria for Adverse Events v 4.03.


From October 2010 to June 2012, 202 pts were enrolled from 32 institutions. Patient characteristics were well balanced between both groups. OS was measured after a median follow-up of 13.5 months. Median PFS was 3.6 and 3.0 months with AMR and DTX, respectively (adjusted Hazard Rate (HR) 0.96, 95% Confidence Interval (CI) 0.69–1.34, p = 0.831). Median OS was 14.6 and 13.5 months with AMR and DTX, respectively (adjusted HR 1.02, 95% CI 0.72–1.43, p = 0.933). ORR was 14.8% and 18.8% with AMR and DTX, respectively (p = 0.544). DCR was 55.7% for both AMR and DTX (p = 1.000). The most frequent adverse events (≥grade 3) for AMR and DTX were neutropenia (82.7% and 78.8%, respectively) and leukopenia (63.3% and 70.7%, respectively). Two treatment-related deaths occurred in the DTX arm: a case of interstitial pneumonia and another of drowning in a bath.


We were not able to demonstrate superiority of AMR over DTX for PFS, despite the 20-day PFS prolongation. Our results suggest that AMR may become a treatment option for patients with previously treated NSCLC.


All authors have declared no conflicts of interest.