title: Randomized, phase III trial of sequential epirubicin and docetaxel versus epirubicin alone in postmenopausal patients with node-positive breast cancer.
abstract: OBJECTIVE
  The Docetaxel Epirubicin Adjuvant (DEVA) trial evaluated the efficacy and toxicity of incorporating docetaxel after epirubicin to create a sequential anthracycline-taxane regimen in early breast cancer.
  
  
  METHODS
  After complete tumor excision, postmenopausal women with node-positive early breast cancer were randomly assigned to either epirubicin 50 mg/m(2) on days 1 and 8 every 4 weeks for six cycles (EPI × 6) or three cycles of epirubicin 50 mg/m(2) on days 1 and 8 every 4 weeks followed by three cycles of docetaxel 100 mg/m(2) on day 1 every 3 weeks (EPI-DOC). A subset of patients also participated in a quality of life (QOL) study. The primary end point was disease-free survival (DFS).
  
  
  RESULTS
  From 1997 to 2005, 803 patients entered DEVA (EPI × 6, n = 397; EPI-DOC, n = 406). At a median follow-up of 64.7 months (interquartile range, 45.2 to 84.4 months), 198 DFS events had been reported (EPI × 6, n = 114; EPI-DOC, n = 84). The 5-year DFS rates were 72.7% (95% CI, 68.0% to 77.3%) for epirubicin alone and 79.5% (95% CI, 75.2% to 83.8%) for epirubicin followed by docetaxel; evidence of improvement in DFS was observed with EPI-DOC (hazard ratio [HR], 0.68; 95% CI, 0.52 to 0.91; P = .008). One hundred twenty-seven patients have died (EPI × 6, n = 75; EPI-DOC, n = 52); a reduction in deaths was observed with EPI-DOC (HR, 0.66; 95% CI, 0.46 to 0.94; P = .02). The 5-year overall survival rates were 81.8% (95% CI, 77.7% to 85.9%) for epirubicin and 88.9% (95% CI, 85.5% to 92.2%) for epirubicin followed by docetaxel. Assessment of toxicity and QOL showed that EPI-DOC was associated with greater toxicity but with no difference in QOL between arms during follow-up.
  
  
  CONCLUSIONS
  These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy.
authors.affiliation: Division of Cancer, Imperial College London, London, United Kingdom. c.coombes@imperial.ac.uk
authors.forename: R Charles
authors.initials: RC
authors.lastname: Coombes
authors.forename: Judith M
authors.initials: JM
authors.lastname: Bliss
authors.forename: Marc
authors.initials: M
authors.lastname: Espie
authors.forename: Frans
authors.initials: F
authors.lastname: Erdkamp
authors.forename: Jacob
authors.initials: J
authors.lastname: Wals
authors.forename: Alejandro
authors.initials: A
authors.lastname: Tres
authors.forename: Michel
authors.initials: M
authors.lastname: Marty
authors.forename: Robert E
authors.initials: RE
authors.lastname: Coleman
authors.forename: Nicole
authors.initials: N
authors.lastname: Tubiana-Mathieu
authors.forename: Marinus O
authors.initials: MO
authors.lastname: den Boer
authors.forename: Andrew
authors.initials: A
authors.lastname: Wardley
authors.forename: Lucy S
authors.initials: LS
authors.lastname: Kilburn
authors.forename: Derek
authors.initials: D
authors.lastname: Cooper
authors.forename: Marina W K
authors.initials: MW
authors.lastname: Thomas
authors.forename: Justine A
authors.initials: JA
authors.lastname: Reise
authors.forename: Katie
authors.initials: K
authors.lastname: Wilkinson
authors.forename: Pierre
authors.initials: P
authors.lastname: Hupperets
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D011788:Quality of Life; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use; D013629:Tamoxifen / Q000627:therapeutic use; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D020845:Selective Estrogen Receptor Modulators; D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D015251:Epirubicin