1519PD - Phase II study of amrubicin in patients with refractory or resistant relapsed small-cell lung cancer: Japan Clinical Oncology Group study (JCOG0901)

Date 29 September 2012
Event ESMO Congress 2012
Session NSCLC - Immunotherapy, SCLC and Mesothelioma
Topics Anticancer agents
Small Cell Lung Cancer
Biological Therapy
Presenter Haruko Daga
Authors H. Daga1, H. Murakami2, N. Yamamoto2, T. Shibata3, M. Endo4, H. Watanabe5, Y. Ichinose6, N. Yamamoto7, Y. Ohe8, T. Tamura7
  • 1Department Of Clinical Oncology, Osaka City General Hospital, 534-0021 - Osaka/JP
  • 2Thoracic Oncology, Shizuoka Cancer Center, JP-411-8777 - Shizuoka/JP
  • 3Regulatory Science Section Multi-institutional Clinical Trial Support Center, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 4Department Of Radiology, Shizuoka Cancer Center, Shizuoka/JP
  • 5Department Of Radiology, National Cancer Center Hospital, Tokyo/JP
  • 6Clinical Research Institute, National Kyushu Cancer Center, JP-811-1395 - Fukuoka/JP
  • 7Department Of Thoracic Oncology, National Cancer Center Hospital, Tokyo/JP
  • 8Thoracic Oncology, National Cancer Center Hospital East, JP-277-8577 - Kashiwa/JP




Standard therapy for refractory or resistant relapsed small-cell lung cancer (SCLC) has not yet been established. We conducted an open-label, multicenter, non-randomized phase II study to confirm the efficacy and safety of amrubicin, a topoisomerase inhibitor, in the treatment of refractory or resistant SCLC.

Material and methods

Patients with SCLC that is refractory or relapsed within 90 days of completing previous treatment received amrubicin at a dose of 40 mg/m2 for 3 consecutive days, every 21 days.The study treatment was repeated until disease progression or intolerable toxicity. The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival (OS), and safety. Planned sample size was 80 patients to achieve power of at least 80% with one-sided alpha of 0.05, and expected and threshold value for primary endpoint as 20% and 10%. All patients were followed-up until one year after the last patient enrollment.


Between November 2009 and February 2011, 82 patients were enrolled from 25 institutions. The median number of treatment cycles was four (range, one to 22 cycles).The ORR was 32.9% (p < 0.0001 by the exact binomial test for null hypothesis that ORR = <10%, 95% CI, 22.9% to 44.2%), with two complete responses and 25 partial responses according to independent assessments.Median PFS and OS were 3.5 months (95% CI, 3.0 to 4.3 months) and 8.9 months (95% CI, 7.6 to 11.3 months), respectively. The most common grade 3 and 4 adverse events were neutropenia (93.9%), leukopenia (85.4%), anemia (25.6%) and thrombocytopenia (20.7%). Twenty-two patients (26.8%) experienced febrile neutropenia. No treatment-related death was observed.


Amrubicin demonstrated the favorable tumor response and survival with acceptable toxicity. Single-agent amrubicin could be considered as a standard regimen in the treatment of refractory or resistant relapsed SCLC.


All authors have declared no conflicts of interest.