title: Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy.
abstract: OBJECTIVE
  There is a need for new agents to treat metastatic breast cancer (MBC) in patients for whom anthracycline therapy has failed or is contraindicated. This study was conducted to assess the efficacy and safety of the novel antineoplastic, the epothilone B analog ixabepilone, in patients with MBC previously treated with an adjuvant anthracycline.
  
  
  METHODS
  Patients were age >or= 18 years and had received a prior anthracycline-based regimen as adjuvant treatment. Ixabepilone as first-line metastatic chemotherapy was administered as a 40 mg/m(2) intravenous infusion during 3 hours every 3 weeks. The primary efficacy end point was objective response rate (ORR). Secondary efficacy end points included duration of response, time to response, time to progression, and survival.
  
  
  RESULTS
  All 65 patients were assessable for response. Their median age was 52 years (range, 33 to 80 years). ORR was 41.5% (95% CI, 29.4% to 54.4%), median duration of response was 8.2 months (95% CI, 5.7 to 10.2 months), and median time to response was 6 weeks (range, 5 to 17 weeks). Median survival was 22.0 months (95% CI, 15.6 to 27.0 months). Treatment-related adverse events were manageable and mostly grades 1/2: the most common of these (other than alopecia) was mild to moderate neuropathy, which was primarily sensory and mostly reversible in nature.
  
  
  CONCLUSIONS
  Ixabepilone is efficacious and has a predictable and manageable safety profile in women with MBC previously treated with an adjuvant anthracycline.
authors.affiliation: Institut Claudius Regaud, 20-24 rue du Saint Pierre, 31052 Toulouse Cedex, France. roche.henri@claudiusregaud.fr
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Louise
authors.initials: L
authors.lastname: Yelle
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
authors.forename: Louis
authors.initials: L
authors.lastname: Mauriac
authors.forename: Craig
authors.initials: C
authors.lastname: Bunnell
authors.forename: Joseph
authors.initials: J
authors.lastname: Sparano
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Delord
authors.forename: Linda
authors.initials: L
authors.lastname: Vahdat
authors.forename: Ronald
authors.initials: R
authors.lastname: Peck
authors.forename: David
authors.initials: D
authors.lastname: Lebwohl
authors.forename: Rana
authors.initials: R
authors.lastname: Ezzeddine
authors.forename: Hervé
authors.initials: H
authors.lastname: Curé
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000494:pharmacology*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D015331:Cohort Studies; D034261:Epothilones / Q000737:chemistry* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D034261:Epothilones; C430592:ixabepilone; C093788:epothilone B