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Multicenter Study
. 2020 Dec:54:121-126.
doi: 10.1016/j.breast.2020.09.004. Epub 2020 Sep 16.

A nationwide, multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK)

Min Ho Park  1 , Soo Jung Lee  2 , Woo Chul Noh  3 , Chang Wan Jeon  4 , Seok Won Lee  5 , Gil Soo Son  6 , Byung-In Moon  7 , Jin Sun Lee  8 , Sung Soo Kang  9 , Young Jin Suh  10 , Geumhee Gwak  11 , Tae Hyun Kim  12 , Young Bum Yoo  13 , Hyun-Ah Kim  3 , Min Young Kim  14 , Ju Yeon Kim  14 , Joon Jeong  15
Affiliations
Multicenter Study

A nationwide, multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK)

Min Ho Park et al. Breast. 2020 Dec.

Abstract

Purpose: Approval of eribulin for metastatic breast cancer was based on data primarily from Western patients, and there is a paucity of data on the effectiveness and safety of eribulin for Asian patients. To determine the effectiveness and safety of eribulin in Korean women with breast cancer in a real-world setting, we conducted a nationwide, multicenter, retrospective study.

Methods: Patients with locally advanced or metastatic breast cancer who were treated with eribulin in 14 centers throughout Korea were included in this study. Eribulin was generally administered at a dose of 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate) by intravenous infusion for 2-5 min, or as a diluted solution, on Days 1 and 8 of every 21-day cycle. The primary endpoint was progression-free survival (PFS) rate at 6 months. Secondary endpoints included median PFS, overall survival (OS), time-to-treatment failure (TTF), tumor response rate, and incidence of hematologic treatment-emergent adverse events (TEAEs).

Results: The safety and full analysis populations included 398 and 360 (38 had no efficacy data) patients, respectively. The PFS rate at 6 months was 37.8%. Median PFS, OS, and TTF were 134, 631, and 120 days, respectively. Objective response rate, clinical benefit rate, and disease control rate were 18.1%, 50.6%, and 49.4%, respectively. Hematologic TEAEs were reported in 65.1% of patients; neutropenia (56.8%) and anemia (11.3%) were most common.

Conclusion: Real-world effectiveness and safety of eribulin in Korean breast cancer patients were consistent with previous reports; no new safety concerns were identified.

Keywords: Breast cancer; Eribulin mesylate; Korean patients; Retrospective study.

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Conflict of interest statement

Declaration of competing interest MYK and JYK are employees of Eisai Korea Inc. All other authors declare no conflict of interest.

Figures

Image 1
Graphical abstract
Fig. 1
Fig. 1
Kaplan–Meier plots are shown for a) progression-free survival, b) overall survival c) time-to-treatment failure; full analysis set. CI, confidence interval; OS, overall survival; PD, progressive disease; PFS, progression-free survival; TTF, time-to-treatment failure.
See this image and copyright information in PMC

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