Abstract
Background
Eribulin has efficacy in patients with progression after ≥ 1 chemotherapeutic regimen
for metastatic breast cancer (MBC). A short disease-free interval (DFI) and previous
use of taxanes in the neoadjuvant or adjuvant setting have been associated with worse
outcomes for patients receiving first-line chemotherapy for HER2-negative MBC. The
aim of the present trial was to evaluate the efficacy and safety of eribulin as first-line
therapy for patients with HER2-negative MBC with these poor prognostic factors.
Patients and Methods
Eribulin monotherapy was administered until disease progression or unacceptable toxicity.
The principal selection criteria were HER2 negativity without previous chemotherapy
for MBC, the previous use of taxanes for early-stage breast cancer, and a DFI of <
36 months (subsequently amended to 48 months). The primary endpoint was the investigator-assessed
time to progression. The secondary endpoints included overall survival, progression-free
survival, objective response rate, clinical benefit rate, duration of response, and
toxicity profile. A total of 53 patients were enrolled and received ≥ 1 dose of eribulin.
Results
The median patient age was 47 years (range, 23-82.8 years). The median DFI was 15.7
months (range, 0.1-46.4 months). The median investigator-assessed time to progression
was 4.1 months (range, 0.2-27.8 months; 95% confidence interval, 3.2-6.2 months).
The objective response and clinical benefit rate was 20.8% and 26.4%, respectively.
All-grade and grade 3/4 adverse events developed in 96.2% and 69.8% of patients, respectively.
The most common treatment-related adverse events were neutropenia, leukopenia, alopecia,
nausea, and anemia.
Conclusion
Eribulin is effective and safe as first-line therapy for aggressive taxane-pretreated
HER2-negative MBC.
Keywords
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Article info
Publication history
Published online: December 19, 2018
Accepted:
December 12,
2018
Received in revised form:
November 22,
2018
Received:
March 8,
2017
Identification
Copyright
© 2018 Elsevier Inc. All rights reserved.
