Format

Send to:

Choose Destination
See comment in PubMed Commons below
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 tony@clo.cuhk.edu.hk.
  • 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.

Abstract

BACKGROUND:

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.

PATIENTS AND METHODS:

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).

RESULTS:

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.

CONCLUSION:

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. Clinicaltrials.gov 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: journals.permissions@oup.com.

KEYWORDS:

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

PMID:
24827127
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire
    Loading ...
    Write to the Help Desk