Eribulin mesylate (E7389): review of efficacy and tolerability in breast, pancreatic, head and neck, and non-small cell lung cancer.
BACKGROUND
Eribulin mesylate is a halichondrin B analogue that acts as a nontaxane microtubule dynamics inhibitor. Eribulin was approved in the United States in 2010 for the treatment of metastatic breast cancer for patients who have received at least 2 metastatic breast cancer chemotherapeutic regimens, including an anthracycline and a taxane. Eribulin is administered as a single agent at 1.4 mg/m(2) IV for 2 to 5 minutes on days 1 and 8 of a 21-day cycle.


OBJECTIVE
The goals of this article are to review eribulin's medication profile, including pharmacology, pharmacokinetic properties, efficacy, and tolerability. Recommendations are provided at the end of the article based on the published information.


METHODS
PubMed, the Cochrane Central Register of Controlled Trials, and Clinical Trials.gov were searched from the beginning of each database through January 3, 2012, for relevant articles on human studies published in English. Search terms included eribulin, eribulin mesylate, and Halaven. Clinical trials, case reports, comparative studies, meta-analyses, evaluation studies, controlled clinical trials, and randomized controlled trials were included as search limits. The references from selected articles were also reviewed to identify additional publications. Eisai, the manufacturer of eribulin mesylate, was also contacted for information regarding trials listed in Clinicaltrials.gov but not yet published.


RESULTS
One Phase III trial was identified that evaluated eribulin for use in patients with metastatic breast cancer. Four Phase II trials were identified that studied eribulin in patients with head and neck, pancreatic, and non-small cell lung cancers. The median overall survival among previously treated metastatic breast cancer patients treated with eribulin was 13.1 months compared with 10.6 months (P = 0.041) with other active chemotherapy for this setting. In non-small cell lung cancer, median overall survival in eribulin-treated patients has been reported as 9.4 months in an unselected population and varies according to taxane sensitivity: 12.6 months in taxane-sensitive disease versus 8.9 months in taxane-resistant disease. Patients with head and neck or pancreatic cancers did not experience improvements in response rates or survival outcomes when treated with eribulin in clinical trials.


CONCLUSIONS
Eribulin is approved by the Food and Drug Administration for patients with previously treated metastatic breast cancer and has demonstrated a survival benefit compared with standard treatment options in this setting. Non-small cell lung cancer patients had improved response rates when treated with eribulin in open-label, nonrandomized, Phase II trials reported in abstract form. Eribulin was not effective in the treatment of head and neck or pancreatic cancer in Phase II trials.
Department of Albany College of Pharmacy and Health Sciences, 106 NewScotland Avenue, Albany, NY 12208, USA. sarah.scarpace@acphs.edu
Sarah L
SL
Scarpace
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D005663:Furans / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D014481:United States; D000095662:Polyether Polyketides
D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides