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

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, Yuukou Kitagawa

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Article number701
JournalBMC Cancer
Volume18
Issue number1
DOIs
Publication statusPublished - 2018 Jun 28

Fingerprint

eribulin
Breast Neoplasms
Confidence Intervals
Safety
Therapeutics
Disease-Free Survival
Anthracyclines
Alopecia
Peripheral Nervous System Diseases
Neutropenia
Disease Progression

Keywords

  • Breast cancer
  • Eribulin
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

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

In: BMC Cancer, Vol. 18, No. 1, 701, 28.06.2018.

Research output: Contribution to journalArticle

Hayashida, Tetsu ; Jinno, Hiromitsu ; Mori, Katsuaki ; Sato, Hiroki ; Matsui, Akira ; Sakurai, Takashi ; Hattori, Hiroaki ; Takayama, Shin ; Wada, Masahiro ; Takahashi, Maiko ; Seki, Hirohito ; Seki, Tomoko ; Nagayama, Aiko ; Matsumoto, Akiko ; Kitagawa, Yuukou. / 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. In: BMC Cancer. 2018 ; Vol. 18, No. 1.
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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.",
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T2 - A multicenter, single-arm trial

AU - Hayashida, Tetsu

AU - Jinno, Hiromitsu

AU - Mori, Katsuaki

AU - Sato, Hiroki

AU - Matsui, Akira

AU - Sakurai, Takashi

AU - Hattori, Hiroaki

AU - Takayama, Shin

AU - Wada, Masahiro

AU - Takahashi, Maiko

AU - Seki, Hirohito

AU - Seki, Tomoko

AU - Nagayama, Aiko

AU - Matsumoto, Akiko

AU - Kitagawa, Yuukou

PY - 2018/6/28

Y1 - 2018/6/28

N2 - 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.

AB - 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.

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KW - Eribulin

KW - Phase II trial

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