A nationwide, multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK)
Min Ho Park,
Soo Jung Lee,
Woo Chul Noh,
Chang Wan Jeon,
Seok Won Lee,
Gil Soo Son,
Byung-In Moon,
Jin Sun Lee,
Sung Soo Kang,
Young Jin Suh,
Geumhee Gwak,
Tae Hyun Kim,
Young Bum Yoo,
Hyun-Ah Kim,
Min Young Kim,
Ju Yeon Kim,
Joon Jeong
Affiliations
Min Ho Park
Department of Surgery, Chonnam National University Medical School, Gwangju, South Korea
Soo Jung Lee
Department of Surgery, Yeungnam University College of Medicine, Daegu, South Korea
Woo Chul Noh
Department of Surgery, Korea Cancer Center Hospital, Seoul, South Korea
Chang Wan Jeon
Department of Surgery, Kosin University Gospel Hospital, Seoul, South Korea
Seok Won Lee
Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
Gil Soo Son
Department of Surgery, Korea University Ansan Hospital, Ansan, South Korea
Byung-In Moon
Department of Surgery, Ewha Women’s University School of Medicine, Seoul, South Korea
Jin Sun Lee
Department of Surgery, Chungnam National University Hospital, Daejeon, South Korea
Sung Soo Kang
Department of Surgery, CHA University Ilsan Medical Center, Goyang, South Korea
Young Jin Suh
Department of Surgery, Catholic University of Korea, St. Vincent’s Hospital, Suwon, South Korea
Geumhee Gwak
Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, South Korea
Tae Hyun Kim
Department of Surgery, Inje University Busan Paik Hospital, Busan, South Korea
Young Bum Yoo
Department of Surgery, Konkuk University Medical Center, Cheongju, South Korea
Hyun-Ah Kim
Department of Surgery, Korea Cancer Center Hospital, Seoul, South Korea
Min Young Kim
Medical Department, Eisai Korea Inc., Seoul, South Korea
Ju Yeon Kim
Medical Department, Eisai Korea Inc., Seoul, South Korea
Joon Jeong
Department of Surgery, Gangnam Severance Hospital Yonsei University, Seoul, South Korea; Corresponding author. Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 06273, South Korea.
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.
