title: Activity of eribulin mesylate in heavily pretreated breast cancer granted access via the Cancer Drugs Fund.
abstract: OBJECTIVE
  Eribulin mesylate is a synthetic analog of halichondrin B and is licensed for the treatment of patients with locally advanced or metastatic breast cancer that has progressed following treatment with anthracyclines and taxanes. It was not deemed to be cost effective based on a cost analysis by the National Institute for Health and Care Excellence in England and therefore it is not funded routinely by the National Health Service. The establishment of the Cancer Drugs Fund in England subsequently enabled access. As with any new chemotherapy drug that enters clinical practice for metastatic breast cancer (MBC) it is often used in heavily pretreated patients and the experience in a routine clinical setting can differ from that in a clinical study. We therefore present the experience of the first 25 cases treated at our institution via the Cancer Drugs Fund.
  
  
  METHODS
  A total of 25 patients were treated and in the 22 assessable cases the objective response rate was 18% (four out of 22), with a clinical benefit rate of 41.0% (9 out of 22).
  
  
  RESULTS
  The median time-to-progression and overall survival were 4.08 months and 5.89 months, respectively. There was a significant difference in clinical benefit rate (odds ratio: 0.065; 95% CI: 0-0.529; p = 0.0055), as well as time-to-progression (hazard ratio: 9.18; 95% CI: 2.26-37.38; p = 0.002 adjusted for age at diagnosis and interval between initial MBC diagnosis and commencing eribulin) favoring those patients who had not been rechallenged. There was no significant difference in overall survival (hazard ratio: 1.16; 95% CI: 0.44-3.05; p = 0.770 adjusted for age at diagnosis and interval between initial diagnosis of MBC and commencing eribulin).
  
  
  CONCLUSIONS
  Eribulin mesylate shows clinical activity; however, there appears to be differences in terms of benefit in patients based on whether patients have been rechallenged with an anthracycline and/or a taxane. These data require confirmation in larger patient groups.
authors.affiliation: Department of Medical Oncology, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.
authors.forename: Ramya
authors.initials: R
authors.lastname: Ramaswami
authors.forename: Sean M
authors.initials: SM
authors.lastname: O'Cathail
authors.forename: James H
authors.initials: JH
authors.lastname: Brindley
authors.forename: Paul
authors.initials: P
authors.lastname: Silcocks
authors.forename: Sarah
authors.initials: S
authors.lastname: Mahmoud
authors.forename: Carlo
authors.initials: C
authors.lastname: Palmieri
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D016527:Drug Costs; D019008:Drug Resistance, Neoplasm; D004739:England; D005260:Female; D005663:Furans / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use*; D061889:Healthcare Financing; D006801:Humans; D053208:Kaplan-Meier Estimate; D007659:Ketones / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides