Phase II evaluation of eribulin mesylate (E7389, NSC 707389) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group trial S0618

Susanne M. Arnold, James Moon, Stephen K. Williamson, James N. Atkins, Sai Hong I. Ou, Michael LeBlanc, Susan G. Urba

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

Purpose Eribulin mesylate, an halichondrin B analog, binds to tubulin and microtubules and possesses broad cancer-anti activity. We conducted a multi-institutional Phase II trial to evaluate the response rate of eribulin mesylate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN). Experimental Design Forty eligible patients who had not received prior chemotherapy for metastatic or recurrent SCCHN were enrolled with the following characteristics: 29 male, 11 female; median age 61.2 years; Zubrod Performance Status of 0 (48%) and 1 (53%). Thirty-three patients (83%) had metastatic disease. Primary tumor sites included: 38% oropharynx, 30% lip/oral cavity, 15% larynx, 10% hypopharynx, 5% other/unknown and 3% nasopharynx. Patients received eribulin mesylate at 1.4 mg/m2 on Days 1 and 8 of an every 21-day cycle. Results Common Grade 3 and 4 toxicities included: lymphopenia (15%), leukocytopenia (13%), neutropenia (10%), hyponatremia (5%), fatigue (5%), diarrhea (5%) and dyspnea (5%), with one treatment-related death due to pulmonary hemorrhage. Among 40 assessable patients, two confirmed partial responses were observed, for an estimated confirmed response rate of 5% (95% confidence interval: 1-17%). The estimated median progression-free survival is 3 months (95% confidence interval: 1-3 months) and estimated median overall survival is 7 months (95% confidence interval: 5-10 months). Conclusions Eribulin mesylate given on Days 1 and 8 of a twenty-one day cycle in metastatic or recurrent SCCHN was well tolerated, but did not result in a clinically significant median PFS. Studies of other agents should be considered in this setting.

Original languageEnglish
Pages (from-to)352-359
Number of pages8
JournalInvestigational New Drugs
Volume29
Issue number2
DOIs
StatePublished - Apr 2011

Bibliographical note

Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA32102, CA38926, CA45808, CA58723, CA35119, CA46113, CA58861, CA35090, CA35178, CA46136, CA58686, CA11083, CA14028, CA04919, CA45377, CA45560, CA37981, CA46441, CA22433 and CA35431.

Keywords

  • Eribulin mesylate
  • Head and neck cancer

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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