A nationwide,multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK) |
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| Institution: | 1. Department of Surgery, Chonnam National University Medical School, Gwangju, South Korea;2. Department of Surgery, Yeungnam University College of Medicine, Daegu, South Korea;3. Department of Surgery, Korea Cancer Center Hospital, Seoul, South Korea;4. Department of Surgery, Kosin University Gospel Hospital, Seoul, South Korea;5. Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea;6. Department of Surgery, Korea University Ansan Hospital, Ansan, South Korea;7. Department of Surgery, Ewha Women’s University School of Medicine, Seoul, South Korea;8. Department of Surgery, Chungnam National University Hospital, Daejeon, South Korea;9. Department of Surgery, CHA University Ilsan Medical Center, Goyang, South Korea;10. Department of Surgery, Catholic University of Korea, St. Vincent’s Hospital, Suwon, South Korea;11. Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, South Korea;12. Department of Surgery, Inje University Busan Paik Hospital, Busan, South Korea;13. Department of Surgery, Konkuk University Medical Center, Cheongju, South Korea;14. Medical Department, Eisai Korea Inc., Seoul, South Korea;15. Department of Surgery, Gangnam Severance Hospital Yonsei University, Seoul, South Korea |
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| Abstract: | PurposeApproval 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.MethodsPatients 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).ResultsThe 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.ConclusionReal-world effectiveness and safety of eribulin in Korean breast cancer patients were consistent with previous reports; no new safety concerns were identified. |
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| Keywords: | Eribulin mesylate Breast cancer Retrospective study Korean patients |
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