title: Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer.
abstract: OBJECTIVE
  Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer, an exploratory analysis was performed to investigate the effect of age in these patients.
  
  
  METHODS
  Data were pooled from two single-arm phase II studies and one open-label randomized phase III study in which patients received eribulin mesylate at 1.4 mg/m(2) as 2- to 5-minute intravenous infusions on days 1 and 8 of a 21-day cycle. The effect of age on median overall survival (OS), progression-free survival (PFS), overall response rate (ORR), clinical benefit rate (CBR), and incidence of adverse events (AEs) was calculated for four age groups (<50 years, 50-59 years, 60-69 years, ≥ 70 years). RESULTS. Overall, 827 patients were included in the analysis (<50 years, n = 253; 50-59 years, n = 289; 60-69 years, n = 206; ≥ 70 years, n = 79). Age had no significant impact on OS (11.8 months, 12.3 months, 11.7 months, and 12.5 months, respectively; p = .82), PFS (3.5 months, 2.9 months, 3.8 months, and 4.0 months, respectively; p = .42), ORR (12.7%, 12.5%, 6.3%, and 10.1%, respectively), or CBR (20.2%, 20.8%, 20.4%, and 21.5%, respectively). Although some AEs had higher incidence in either the youngest or the oldest subgroup, there was no overall effect of age on the incidence of AEs (including neuropathy, neutropenia, and leukopenia).
  
  
  CONCLUSIONS
  Eribulin monotherapy in these selected older patients with good baseline performance status led to OS, PFS, ORR, CBR, and tolerability similar to those of younger patients with metastatic breast cancer. The benefits and risks of eribulin appear to be similar across age groups.
authors.affiliation: University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, USA; Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain; Weill Cornell Medical College, New York, New York, USA; Jules Bordet Institute, Brussels, Belgium; University of Leeds and St James's Institute of Oncology, Leeds, UK; Formerly of Eisai Ltd, Hatfield, UK; Eisai Inc., Woodcliff Lake, New Jersey, USA; NJS Associates Company, Somerset, New Jersey USA; Baylor-Charles A. Sammons Cancer Center, Texas Oncology, and US Oncology, Dallas, Texas, USA.
authors.forename: Hyman
authors.initials: H
authors.lastname: Muss
authors.forename: Javier
authors.initials: J
authors.lastname: Cortes
authors.forename: Linda T
authors.initials: LT
authors.lastname: Vahdat
authors.forename: Fatima
authors.initials: F
authors.lastname: Cardoso
authors.forename: Chris
authors.initials: C
authors.lastname: Twelves
authors.forename: Jantien
authors.initials: J
authors.lastname: Wanders
authors.forename: Corina E
authors.initials: CE
authors.lastname: Dutcus
authors.forename: Jay
authors.initials: J
authors.lastname: Yang
authors.forename: Seth
authors.initials: S
authors.lastname: Seegobin
authors.forename: Joyce
authors.initials: J
authors.lastname: O'Shaughnessy
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005663:Furans / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D012189:Retrospective Studies; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Age; Chemotherapy; Eribulin mesylate; Metastatic breast cancer