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Ann Oncol. 2014 Aug;25(8):1578-84. doi: 10.1093/annonc/mdu174. Epub 2014 May 14.

Randomized phase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with previously treated advanced non-small-cell lung cancer.

Author information

  • 1Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China
  • 2Prince of Songkla University, Songkhla, Thailand.
  • 3Hematology Oncology Associates, Port St Lucie, USA.
  • 4Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
  • 5US Oncology Research, Houston Virginia Cancer Specialists, Fairfax.
  • 6US Oncology Research, Houston Compass Oncology, Vancouver, USA.
  • 7Department of Clinical Oncology, The University of Hong Kong, Hong Kong, China.
  • 8Department of Medical Oncology, National Cancer Centre, Singapore, Republic of Singapore.
  • 9Eisai Inc., Woodcliff Lake, USA.
  • 10Eisai Ltd, Hatfield, UK.
  • 11US Oncology Research, Houston Ocala Oncology, Ocala, USA.



This phase II, open-label study investigated intercalated combinations of eribulin and erlotinib in unselected patients with advanced non-small-cell lung cancer previously treated with platinum-based chemotherapies.


Eligible patients were randomized to eribulin mesylate 2.0 mg/m(2) on day 1 with erlotinib 150 mg on days 2-16 (21-day regimen) or eribulin mesylate 1.4 mg/m(2) on days 1 and 8 with erlotinib 150 mg on days 15-28 (28-day regimen). The primary end point was objective response rate (ORR).


One hundred and twenty-three patients received ≥ 1 cycle of therapy (63, 21-day regimen; 60, 28-day regimen). ORRs were 13% [95% confidence interval (CI) 6%-24%] and 17% (95% CI 8%-29%), and disease control rates were 48% (95% CI 35%-61%) and 63% (95% CI 50%-75%) for the 21- and 28-day regimens, respectively. The median progression-free survival and overall survival were similar with both regimens. Both regimens were well tolerated with common grade ≥ 3 toxicities being neutropenia, asthenia/fatigue, and dyspnoea. Sequential administration of erlotinib did not interfere with the pharmacokinetic profile of eribulin.


Intercalated combination of eribulin and erlotinib demonstrated modest activity and the addition of erlotinib did not appear to improve treatment outcome in an unselected population. The 28-day regimen is suitable for further investigation. identifier: NCT01104155.

© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email:


biomarker; eribulin; erlotinib; non-small-cell lung cancer; platinum-based doublet chemotherapy

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