title: Efficacy and safety of ixabepilone in taxane-resistant patients with metastatic breast cancer previously treated with anthracyclines: results of a phase II study in Japan.
abstract: OBJECTIVE
  Anthracycline and taxane resistance is a key issue in the treatment of metastatic breast cancer (MBC), particularly in Asian patients who often present with advanced disease. The objective of this study was to investigate the efficacy and safety of ixabepilone monotherapy in Japanese patients with taxane-resistant MBC previously treated with anthracycline.
  
  
  METHODS
  Japanese patients with taxane-resistant MBC previously treated with anthracycline were treated with 40 mg/m(2) ixabepilone every 3 weeks. Primary endpoint was overall response rate. Secondary endpoints included duration of response, time to progression (TTP), and safety.
  
  
  RESULTS
  Fifty-two patients were treated with ixabepilone. Overall response rate was 11.5 % (95 % confidence interval 4.4-23.4), stable disease rate was 38.5 %, duration of response was 3.6 months (range 2.4-5.3 months), and TTP was 2.8 months (range 0.7-8.1 months). The most frequent grade 3/4 toxicities were neutropenia (82.7 %), leukopenia (75 %), myalgia (19.2 %), and peripheral neuropathy (19.2 %).
  
  
  CONCLUSIONS
  Ixabepilone monotherapy was effective and toxicities were manageable in this phase II study of Japanese patients with taxane-resistant metastatic breast cancer previously treated with anthracyclines.
authors.affiliation: Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-cho, Matsuyama, Ehime 791-0280, Japan. kaogi@shikoku-cc.go.jp
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Rai
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Junichiro
authors.initials: J
authors.lastname: Watanabe
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.forename: Takuto
authors.initials: T
authors.lastname: Tokudome
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D034261:Epothilones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D034261:Epothilones; D043823:Taxoids; C430592:ixabepilone