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Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer.

Author information

1
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.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00097721 NCT00246090 NCT00388726.

KEYWORDS:

Age; Chemotherapy; Eribulin mesylate; Metastatic breast cancer

PMID:
24682463
PMCID:
PMC3983814
DOI:
10.1634/theoncologist.2013-0282
[Indexed for MEDLINE]
Free PMC Article

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