title: Feasibility and Efficacy of Eribulin Mesilate in Korean Patients with Metastatic Breast Cancer: Korean Multi-center Phase IV Clinical Study Results.
abstract: OBJECTIVE
  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.
  
  
  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/m2dose 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.
  
  
  CONCLUSIONS
  This study demonstrated the feasible safety profile and activity of eribulin in Korean patients with MBC.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yeon Hee
authors.initials: YH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Tae Yong
authors.initials: TY
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Young-Hyuck
authors.initials: YH
authors.lastname: Im
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, National Cancer Center, Goyang, Korea.
authors.forename: Keun-Seok
authors.initials: KS
authors.lastname: Lee
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, National Cancer Center, Goyang, Korea.
authors.forename: In Hae
authors.initials: IH
authors.lastname: Park
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Joohyuk
authors.initials: J
authors.lastname: Sohn
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Soo-Hyeon
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Se Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, Korea.
authors.forename: Soo Jung
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Division of Medical Oncology, Department of Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Su-Jin
authors.initials: SJ
authors.lastname: Koh
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.
authors.forename: Ki Hyeong
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Yoon Ji
authors.initials: YJ
authors.lastname: Choi
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, Dong-A University Medical Center, Busan, Korea.
authors.forename: Suee
authors.initials: S
authors.lastname: Lee
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Seok Yun
authors.initials: SY
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Jae Hong
authors.initials: JH
authors.lastname: Seo
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Sung-Bae
authors.initials: SB
authors.lastname: Kim
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Kyung Hae
authors.initials: KH
authors.lastname: Jung
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D003131:Combined Modality Therapy; D005260:Female; D005663:Furans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D056910:Republic of Korea; D019233:Retreatment; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Breast neoplasms; Eribulin; Korean; Metastasis; Phase IV clinical trial; Safety