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Feasibility and Efficacy of Eribulin Mesilate in Korean Patients with Metastatic Breast Cancer: Korean Multi-center Phase IV Clinical Study Results

Cancer Research and Treatment 2017년 49권 2호 p.423 ~ p.429

박연희(Park Yeon-Hee) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine
김태영(Kim Tae-Yong) - Seoul National University College of Medicine Department of Internal Medicine
임영혁(Im Young-Hyuck) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine
이근석(Lee Keun-Seok) - National Cancer Center Department of Internal Medicine
박인혜(Park In-Hae) - National Cancer Center Department of Internal Medicine
손주혁(Sohn Joo-Hyuk) - Yonsei University College of Medicine Department of Internal Medicine
이수현(Lee Soo-Hyeon) - Yonsei University College of Medicine Department of Internal Medicine
임석아(Im Seock-Ah) - Seoul National University College of Medicine Department of Internal Medicine
김지현(Kim Jee-Hyun) - Seoul National University Bundang Hospital Department of Internal Medicine
김세현(Kim Se-Hyun) - Seoul National University Bundang Hospital Department of Internal Medicine
이수정(Lee Soo-Jung) - Kyungpook National University School of Medicine Kyungpook National University Medical Center Department of Internal Medicine
고수진(Koh Su-Jin) - University of Ulsan College of Medicine Ulsan University Hospital Department of Medicine
이기형(Lee Ki-Hyeong) - Chungbuk National University College of Medicine Department of Internal Medicine
최윤지(Choi Yoon-Ji) - Korea University College of Medicine Department of Internal Medicine
조은경(Cho Eun-Kyung) - Gachon University Gil Medical Center Department of Internal Medicine
이수이(Lee Suee) - Dong-A University College of Medicine Department of Internal Medicine
강석윤(Kang Seok-Yun) - Ajou University School of Medicine Department of Internal Medicine
서재홍(Seo Jae-Hong) - Korea University College of Medicine Korea University Guro Hospital Department of Internal Medicine Division of Oncology-Hematology
김성배(Kim Sung-Bae) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology
정경해(Jung Kyung-Hae) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology

Abstract

Purpose: Eribulin mesilate was approved for the treatment of patients with locally advanced or metastatic breast cancer (MBC), who had received at least two chemotherapeutic regimens, including anthracycline and taxane. On the other hand, the efficacy and safety information of eribulin in Korean patients is limited by the lack of clinical trials.

Materials and Methods: In this multicenter, open-label, single-arm, phase IV study, locally advanced or MBC patients were enrolled between June 2013 and April 2014 from 14 centers in Korea. One point four mg/m2 dose of eribulin was administered on days 1 and 8 of every 21 days. The primary endpoint was the frequency and intensity of the treatment emergent adverse event. The secondary endpoint was the disease control rate, which included the rate of complete responses, partial responses, and stable disease.

Results: A total of 101 patients received at least one dose of eribulin and were included in the safety set. The patients received a total of 543 treatment cycles, with a median of three cycles (range, 1 to 31 cycles). The most common adverse event was neutropenia (91.1% of patients, 48.3% of cycles). The frequent non-hematological adverse events included alopecia, decrease in appetite, fatigue/asthenia, and myalgia/arthralgia. The peripheral neuropathy of any grade occurred in 27 patients (26.7%), including grade 3 in two patients. Disease control rate was 52.7% and 51.3% of patients in the full analysis set and per-protocol set, respectively.

Conclusion: This study demonstrated the feasible safety profile and activity of eribulin in Korean patients with MBC.