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BMC Cancer
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Research article

Phase II trial of eribulin mesylate as a first- or second-line treatment for locally advanced or metastatic breast cancer: a multicenter, single-arm trial

Authors: Tetsu Hayashida, Hiromitsu Jinno, Katsuaki Mori, Hiroki Sato, Akira Matsui, Takashi Sakurai, Hiroaki Hattori, Shin Takayama, Masahiro Wada, Maiko Takahashi, Hirohito Seki, Tomoko Seki, Aiko Nagayama, Akiko Matsumoto, Yuko Kitagawa

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

Eribulin mesylate is currently indicated as a sequential monotherapy to be administered after two chemotherapeutic regimens, including anthracycline and taxane treatments, for treatment of metastatic breast cancer. This open-label, multicenter phase II study was designed to evaluate the efficacy and safety of eribulin as a first- or second-line treatment for patients with metastatic breast cancer.

Methods

The primary objective was to determine the overall response rate. Secondary objectives were to evaluate progression-free survival and the safety profile. Patients were scheduled to receive eribulin mesylate 1.4 mg/m2 intravenously on days 1 and 8 of a 21-day cycle. Patients received the study treatment unless disease progression, unacceptable toxicity, or a request to discontinue from the patient and/or investigator eventuated.

Results

Between December 2012 and September 2015, 32 patients with metastatic breast cancer were enrolled at 10 participating clinical institutions in Japan, and toxicity and response rates were evaluated. The overall response rate was 43.8% (95% confidence interval [CI] 26.5–61.0). The clinical benefit and tumor control rates were 56.3% (95% CI 39.0–73.5) and 78.1% (95% CI 63.8–92.5), respectively. Median progression-free survival was 8.3 months (95% CI 7.1–9.4). A subgroup analysis did not identify any factors affecting the efficacy of eribulin. The most common adverse events were neutropenia (71.9%), alopecia (68.7%), and peripheral neuropathy (46.9%). As a first- or second-line therapy, eribulin showed sufficient efficacy for metastatic breast cancer compared with taxane and capecitabine treatment in previous clinical trials. The safety profile of eribulin was acceptable.

Conclusions

Eribulin may be another option for first-line chemotherapeutic regimens for metastatic breast cancer.

Trial registrations

This trial was retrospectively registered at the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (ID number: UMIN000010334).
Date of trial registration: April 1st, 2013.
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Metadata
Title
Phase II trial of eribulin mesylate as a first- or second-line treatment for locally advanced or metastatic breast cancer: a multicenter, single-arm trial
Authors
Tetsu Hayashida
Hiromitsu Jinno
Katsuaki Mori
Hiroki Sato
Akira Matsui
Takashi Sakurai
Hiroaki Hattori
Shin Takayama
Masahiro Wada
Maiko Takahashi
Hirohito Seki
Tomoko Seki
Aiko Nagayama
Akiko Matsumoto
Yuko Kitagawa
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4628-7

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