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

Tony S. Mok, S. L. Geater, N. Iannotti, S. Thongprasert, A. Spira, D. Smith, V. Lee, W. T. Lim, L. Reyderman, B. Wang, P. Gopalakrishna, F. Garzon, L. Xu, C. Reynolds

Research output: Contribution to journalArticle

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/m2 on day 1 with erlotinib 150 mg on days 2-16 (21-day regimen) or eribulin mesylate 1.4 mg/m2 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.

Original languageEnglish (US)
Article numbermdu174
Pages (from-to)1578-1584
Number of pages7
JournalAnnals of Oncology
Volume25
Issue number8
DOIs
StatePublished - Aug 2014
Externally publishedYes

Keywords

  • Biomarker
  • Eribulin
  • Erlotinib
  • Non-small-cell lung cancer
  • Platinum-based doublet chemotherapy

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Mok, T. S., Geater, S. L., Iannotti, N., Thongprasert, S., Spira, A., Smith, D., Lee, V., Lim, W. T., Reyderman, L., Wang, B., Gopalakrishna, P., Garzon, F., Xu, L., & Reynolds, C. (2014). Randomized phase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with reviously treated advanced non-small-cell lung cancer. Annals of Oncology, 25(8), 1578-1584. [mdu174]. https://doi.org/10.1093/annonc/mdu174