Highlights
- •This study was a prospective randomized phase II, multicentre study comparing EG with PG for MBC patients.
- •The 6-month PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457).
- •EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of progression-free survival but less neurotoxicity.
Abstract
Background
Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic
regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin
non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin
showed improved overall survival (OS) in various MBC patient subgroups pretreated
with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than
paclitaxel.
Patients and methods
This study was a prospective randomised phase II, open-label, two-arm, multicentre
study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line
treatment for patients with human epidermal growth factor receptor 2-negative MBC.
We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The
primary end-point was progression-free survival (PFS), which was estimated to be 70%
at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic
scale, toxicity and clinical benefit rate.
Results
A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and
March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month
PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2
months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for
PG (range 2–32). Clinical benefit rates were 44% for EG and 49% for PG. Major toxicities
were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common
with PG than with EG (13.6% for EG versus 45.8% for PG, P < 0.0001).
Conclusion
EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but
less neurotoxicity.
Trial registration
KCSG BR13-11; ClinicalTrials.gov, NCT02263495.
Keywords
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Article info
Publication history
Published online: October 31, 2017
Accepted:
October 1,
2017
Received in revised form:
September 13,
2017
Received:
August 10,
2017
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.
