title: Safety and tolerability of eribulin mesylate in patients with pretreated metastatic breast cancer.
abstract: OBJECTIVE
  The safety and tolerability of eribulin mesylate for the treatment of metastatic breast cancer (MBC) are examined.
  
  
  METHODS
  This retrospective analysis used pooled safety and tolerability data from three Phase II trials and one Phase III trial of eribulin in patients with MBC. In these studies, patients with pretreated MBC received eribulin mesylate 1.4 mg/m(2) as a two- to five-minute i.v. infusion on days 1 and 8 of a 21-day cycle. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events, version 3.0.
  
  
  RESULTS
  Across the four trials, 908 patients received eribulin and were assessed for safety. Aside from anthracyclines and taxanes, the most common prior chemotherapy agents were capecitabine, vinorelbine, and gemcitabine. Patients had received a mean of 3.7 (range, 1-11) prior chemotherapeutic regimens. Dose delays, reductions, and interruptions due to treatment-emergent adverse events occurred in 35.0%, 17.3%, and 2.9% of patients, respectively. Treatment was discontinued in 12.3% of patients due to adverse events, regardless of whether the adverse event was considered treatment related. The most common grade 3 or 4 treatment-related adverse events were neutropenia (52.4%) and leukopenia (19.3%). Serious adverse events occurred in 26.1% of patients, with the most common being febrile neutropenia (3.6%) and pyrexia (2.3%). Peripheral neuropathy was seen in 30.6% of patients, with 6.6% experiencing grade 3 or 4 reactions.
  
  
  CONCLUSIONS
  Despite heavy pretreatment with anthracyclines, taxanes, and capecitabine, eribulin was well tolerated in this pooled analysis of patients with MBC.
authors.affiliation: Susan Goodin, Pharm.D., BCOP, is Professor of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick. Sally Barbour, Pharm.D., BCOP, is Director, Oncology Pharmacy Programs, Durham, NC. James Song, Ph.D., is Associate Director of Biostatistics, Medical Affairs; and Erhan Berrak, M.D., is Medical Director, Oncology, Eisai Inc., Woodcliff Lakes, NJ. David Cox, Ph.D., is Vice President, Medical Affairs, Ipsen Biopharmaceuticals, Basking Ridge, NJ; at the time of writing he was Group Director, Oncology Medical Strategy, Eisai Inc. goodin@cinj.rutgers.edu.
authors.forename: Susan
authors.initials: S
authors.lastname: Goodin
authors.affiliation: Susan Goodin, Pharm.D., BCOP, is Professor of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick. Sally Barbour, Pharm.D., BCOP, is Director, Oncology Pharmacy Programs, Durham, NC. James Song, Ph.D., is Associate Director of Biostatistics, Medical Affairs; and Erhan Berrak, M.D., is Medical Director, Oncology, Eisai Inc., Woodcliff Lakes, NJ. David Cox, Ph.D., is Vice President, Medical Affairs, Ipsen Biopharmaceuticals, Basking Ridge, NJ; at the time of writing he was Group Director, Oncology Medical Strategy, Eisai Inc.
authors.forename: Sally
authors.initials: S
authors.lastname: Barbour
authors.affiliation: Susan Goodin, Pharm.D., BCOP, is Professor of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick. Sally Barbour, Pharm.D., BCOP, is Director, Oncology Pharmacy Programs, Durham, NC. James Song, Ph.D., is Associate Director of Biostatistics, Medical Affairs; and Erhan Berrak, M.D., is Medical Director, Oncology, Eisai Inc., Woodcliff Lakes, NJ. David Cox, Ph.D., is Vice President, Medical Affairs, Ipsen Biopharmaceuticals, Basking Ridge, NJ; at the time of writing he was Group Director, Oncology Medical Strategy, Eisai Inc.
authors.forename: James
authors.initials: J
authors.lastname: Song
authors.affiliation: Susan Goodin, Pharm.D., BCOP, is Professor of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick. Sally Barbour, Pharm.D., BCOP, is Director, Oncology Pharmacy Programs, Durham, NC. James Song, Ph.D., is Associate Director of Biostatistics, Medical Affairs; and Erhan Berrak, M.D., is Medical Director, Oncology, Eisai Inc., Woodcliff Lakes, NJ. David Cox, Ph.D., is Vice President, Medical Affairs, Ipsen Biopharmaceuticals, Basking Ridge, NJ; at the time of writing he was Group Director, Oncology Medical Strategy, Eisai Inc.
authors.forename: Erhan
authors.initials: E
authors.lastname: Berrak
authors.affiliation: Susan Goodin, Pharm.D., BCOP, is Professor of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick. Sally Barbour, Pharm.D., BCOP, is Director, Oncology Pharmacy Programs, Durham, NC. James Song, Ph.D., is Associate Director of Biostatistics, Medical Affairs; and Erhan Berrak, M.D., is Medical Director, Oncology, Eisai Inc., Woodcliff Lakes, NJ. David Cox, Ph.D., is Vice President, Medical Affairs, Ipsen Biopharmaceuticals, Basking Ridge, NJ; at the time of writing he was Group Director, Oncology Medical Strategy, Eisai Inc.
authors.forename: David
authors.initials: D
authors.lastname: Cox
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D005663:Furans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007659:Ketones / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides