A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated nonsmall-cell lung cancer

Alexander I. Spira, Nicholas O. Iannotti, Michael A. Savin, Marcus Neubauer, Nashat Y. Gabrail, Ronald H. Yanagihara, Edith A. Zang, Patricia E. Cole, Dale Shuster, Asha Das

Research output: Contribution to journalArticle

Abstract

This open-label phase II study assessed the efficacy and tolerability of eribulin, a non-taxane microtubule dynamics inhibitor with novel mechanism of action, as monotherapy in patients who have advanced nonsmall-cell lung cancer (NSCLC). Enrolled patients had progressed during or after platinum-based doublet chemotherapy. Initially, two patient cohorts (taxanepre-treated and taxane-nave) received eribulin mesylate (1.4 mg/m 2) as a 2- to 5-minute intravenous infusion on days 1, 8, and 15 of a 28-day cycle. To assess tolerability of a second dosing schedule, a cohort of taxanepre-treated patients received eribulin on days 1 and 8 of a 21-day cycle. The primary endpoint was objective response rate (ORR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) by independent radiographic review. One hundred three patients received eribulin. The ORR was 9.7% (all partial responses [PR]). Overall disease control rate (PR + stable disease) was 55.3%. Median duration of response, progression-free survival, and overall survival were 5.8, 3.4, and 9.4 months, respectively. The most common drug-related adverse events were neutropenia (54%; 49% grade 3/4); fatigue (49%; 11% grade 3, no grade 4); nausea (38%; 1% grade 3, no grade 4); alopecia (32%); anemia (29%, 4% grade 3/4) and neuropathy (23%; 2% grade 3, no grade 4). The 28-day schedule was associated with many dose delays, interruptions, or omissions due to neutropenia (day 15). The 21-day cycle was well-tolerated. Eribulin monotherapy administered on days 1 and 8 of a 21-day cycle is active and tolerated as second- or later-line chemotherapy for NSCLC.

Original languageEnglish (US)
Pages (from-to)31-38
Number of pages8
JournalClinical lung cancer
Volume13
Issue number1
DOIs
StatePublished - Jan 1 2012
Externally publishedYes

Keywords

  • Chemotherapy
  • Halichondrin B
  • Microtubule
  • Monotherapy
  • Tubulin

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Fingerprint Dive into the research topics of 'A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated nonsmall-cell lung cancer'. Together they form a unique fingerprint.

  • Cite this

    Spira, A. I., Iannotti, N. O., Savin, M. A., Neubauer, M., Gabrail, N. Y., Yanagihara, R. H., Zang, E. A., Cole, P. E., Shuster, D., & Das, A. (2012). A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated nonsmall-cell lung cancer. Clinical lung cancer, 13(1), 31-38. https://doi.org/10.1016/j.cllc.2011.06.010