PMID- 24682463
OWN - NLM
STAT- MEDLINE
DCOM- 20150112
LR  - 20211021
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 19
IP  - 4
DP  - 2014 Apr
TI  - Eribulin monotherapy in patients aged 70 years and older with metastatic breast 
      cancer.
PG  - 318-27
LID - 10.1634/theoncologist.2013-0282 [doi]
AB  - PURPOSE: 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). CONCLUSION: 
      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.
FAU - Muss, Hyman
AU  - Muss H
AD  - 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.
FAU - Cortes, Javier
AU  - Cortes J
FAU - Vahdat, Linda T
AU  - Vahdat LT
FAU - Cardoso, Fatima
AU  - Cardoso F
FAU - Twelves, Chris
AU  - Twelves C
FAU - Wanders, Jantien
AU  - Wanders J
FAU - Dutcus, Corina E
AU  - Dutcus CE
FAU - Yang, Jay
AU  - Yang J
FAU - Seegobin, Seth
AU  - Seegobin S
FAU - O'Shaughnessy, Joyce
AU  - O'Shaughnessy J
LA  - eng
SI  - ClinicalTrials.gov/NCT00097721
SI  - ClinicalTrials.gov/NCT00246090
SI  - ClinicalTrials.gov/NCT00388726
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140328
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Furans)
RN  - 0 (Ketones)
RN  - LR24G6354G (eribulin)
SB  - IM
CIN - Oncologist. 18:8. PMID: 23263290
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - *Aging
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Female
MH  - Furans/*adverse effects/*therapeutic use
MH  - Humans
MH  - Ketones/*adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Neoplasm Metastasis/drug therapy
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC3983814
OTO - NOTNLM
OT  - Age
OT  - Chemotherapy
OT  - Eribulin mesylate
OT  - Metastatic breast cancer
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2014/04/01 06:00
MHDA- 2015/01/13 06:00
PMCR- 2015/04/01
CRDT- 2014/04/01 06:00
PHST- 2014/04/01 06:00 [entrez]
PHST- 2014/04/01 06:00 [pubmed]
PHST- 2015/01/13 06:00 [medline]
PHST- 2015/04/01 00:00 [pmc-release]
AID - theoncologist.2013-0282 [pii]
AID - T13282 [pii]
AID - 10.1634/theoncologist.2013-0282 [doi]
PST - ppublish
SO  - Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 
      2014 Mar 28.