title: Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies.
abstract: BACKGROUND
  Metastatic breast cancer (MBC) patients with rapid disease relapse after neo/adjuvant chemotherapy including anthracyclines and taxanes have limited treatment options and their efficacy is marginal. Two phase III studies compared ixabepilone plus capecitabine vs. capecitabine alone as first-line treatment in MBC patients pretreated with anthracyclines and taxanes in the neo/adjuvant setting. Here we report the efficacy and safety of these treatments in a prespecified subset of patients whose disease relapsed within 12 months.
  
  
  METHODS
  Of 1973 patients across two studies, 293 relapsed within 12 months of neo/adjuvant treatment and received ixabepilone plus capecitabine (n = 149) or capecitabine alone (n = 144) as first-line chemotherapy for MBC. Analysis included progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and toxicity.
  
  
  RESULTS
  In 293 patients, ixabepilone plus capecitabine, as compared to capecitabine alone, increased PFS (median: 5.6 months vs. 2.8 months; hazard ratio, 0.58; p < 0.0001), ORR (46% vs. 24%) and OS (median: 15.1 months vs. 12.5 months; hazard ratio, 0.84; p = 0.208). Major toxicities of this regimen included neuropathy, neutropenia and hand-foot syndrome, but were manageable.
  
  
  CONCLUSIONS
  Patients with breast cancer with early relapse following neo/adjuvant treatment with anthracyclines and taxanes may benefit from ixabepilone plus capecitabine. (ClinicalTrials.gov identifiers: NCT00080301 and NCT00082433.).
authors.affiliation: Department of Oncology and Radiotherapy, Medical University of Gdansk, Poland. jjassem@amg.gda.pl
authors.forename: Jacek
authors.initials: J
authors.lastname: Jassem
authors.forename: Luis
authors.initials: L
authors.lastname: Fein
authors.forename: Mark
authors.initials: M
authors.lastname: Karwal
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Ronald
authors.initials: R
authors.lastname: Peck
authors.forename: Valerie
authors.initials: V
authors.lastname: Poulart
authors.forename: Linda
authors.initials: L
authors.lastname: Vahdat
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D034261:Epothilones / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D034261:Epothilones; D043823:Taxoids; D003841:Deoxycytidine; D000069287:Capecitabine; C430592:ixabepilone; D005472:Fluorouracil