title: Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes.
abstract: OBJECTIVE
  Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC.
  
  
  METHODS
  In this phase II, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed human epidermal growth factor receptor 2-negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014). Objective response rate (ORR; primary endpoint), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety were evaluated.
  
  
  RESULTS
  Of 53 recruited patients, 47 were enrolled. The ORR was 17.0% (95% confidence interval, 7.6-30.8), DCR was 66.0% (51.2-77.8), median PFS was 4.9 months (3.5-7.0), DOR was 6.6 months (1.9-14.3), and median OS was 17.4 months (10.1-not evaluable). The common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leucopenia (16 patients; 42.1%) and febrile neutropenia (4 patients; 8.5%). Toxicity did not increase during the long-term treatment. Subgroup analysis indicated that first-line treatment led to higher ORR and prolonged PFS and OS than second-/third-line treatment and that incidence of adverse events in patients of second-/third-line treatment was not higher than that in patients of first-line treatment.
  
  
  CONCLUSIONS
  Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).
authors.affiliation: Department of Surgery, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan. Electronic address: maedash@nagasaki-mc.com.
authors.forename: Shigeto
authors.initials: S
authors.lastname: Maeda
authors.affiliation: Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.
authors.forename: Michiyo
authors.initials: M
authors.lastname: Saimura
authors.affiliation: Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Minami
authors.affiliation: Department of Breast Surgery, Urasoe General Hospital, Urasoe, Okinawa, Japan.
authors.forename: Kaname
authors.initials: K
authors.lastname: Kurashita
authors.affiliation: Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto, Japan.
authors.forename: Reiki
authors.initials: R
authors.lastname: Nishimura
authors.affiliation: Department of Breast Surgery, Ueo Breast Cancer Hospital, Oita, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Kai
authors.affiliation: Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yano
authors.affiliation: Department of Surgery, Oita Prefectural Hospital, Oita, Japan.
authors.forename: Kohjiro
authors.initials: K
authors.lastname: Mashino
authors.affiliation: Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.
authors.forename: Shoshu
authors.initials: S
authors.lastname: Mitsuyama
authors.affiliation: Department of Cancer Information Center, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan.
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Shimokawa
authors.affiliation: Division of Medical Oncology, Hematology and Infectious Disease, Fukuoka University, Fukuoka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016001:Confidence Intervals; D018572:Disease-Free Survival; D005260:Female; D005663:Furans / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D007659:Ketones / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D018943:Anthracyclines; D005663:Furans; D007659:Ketones; D043823:Taxoids; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Dose-intensity; Eribulin; First-line; Metastatic breast cancer; Microtubule