title: A phase II study of eribulin in Japanese patients with heavily pretreated metastatic breast cancer.
abstract: BACKGROUND
  Eribulin mesylate is a non-taxane microtubule dynamics inhibitor that recently gained Food and Drug Administration approval for late-line metastatic breast cancer (MBC).
  
  
  METHODS
  In this single-arm, multicentre open-label phase II trial Japanese patients pretreated with an anthracycline and a taxane received 1.4 mg/m(2) eribulin mesylate (2- to 5-min i.v. infusion on days 1 and 8 of a 21-day cycle). The primary efficacy end point was overall response rate (ORR) by independent review.
  
  
  RESULTS
  Patients (N = 80) had received a median of three prior chemotherapy regimens (range 1-5). ORR was 21.3% [95% confidence interval (CI) 12.9-31.8; all partial responses (PRs)], stable disease (SD) occurred in 30 patients (37.5%) and the clinical benefit rate (complete response + PR + SD ≥6 months) was 27.5% (95% CI 18.1-38.6). Median duration of response was 3.9 months (95% CI 2.8-4.9), progression-free survival was 3.7 months (95% CI 2.0-4.4) and overall survival was 11.1 months (95% CI 7.9-15.8). The most frequent treatment-related grade 3/4 adverse events were neutropenia (95.1%), leukopenia (74.1%) and febrile neutropenia (13.6%). Grade 3 peripheral neuropathy occurred in 3.7% of patients (no grade 4).
  
  
  CONCLUSIONS
  Eribulin exhibited efficacy and tolerability in Japanese patients with heavily pretreated MBC.
authors: Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan. kaogi@shikoku-cc.go.jp
authors: K
authors: K
authors: Aogi
authors: H
authors: H
authors: Iwata
authors: N
authors: N
authors: Masuda
authors: H
authors: H
authors: Mukai
authors: M
authors: M
authors: Yoshida
authors: Y
authors: Y
authors: Rai
authors: K
authors: K
authors: Taguchi
authors: Y
authors: Y
authors: Sasaki
authors: S
authors: S
authors: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000494:pharmacology; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D005663:Furans / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D007659:Ketones / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008207:Lymphatic Metastasis; D008875:Middle Aged; D043823:Taxoids / Q000494:pharmacology; D016896:Treatment Outcome; D047368:Tumor Burden / Q000187:drug effects; D000095662:Polyether Polyketides
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; D043823:Taxoids; C490954:eribulin; D000095662:Polyether Polyketides