title: Final results of ERASME-4: a randomized trial of first-line docetaxel plus either capecitabine or epirubicin for metastatic breast cancer.
abstract: OBJECTIVE
  To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC).
  
  
  METHODS
  Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m(2) twice daily, days 1-14; docetaxel 75 mg/m(2), day 1) or ET (epirubicin 75 mg/m(2), day 1; docetaxel 75 mg/m(2), day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design.
  
  
  RESULTS
  Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months' median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience.
  
  
  CONCLUSIONS
  Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.
authors: Département de Cancérologie Médicale et Unité INSERM U590Centre Léon Bérard, 28 rue LaënnecFR–69373 Lyon Cedex 08, France. bachelot@lyon.fnclcc.fr
authors: Thomas
authors: T
authors: Bachelot
authors: Agathe
authors: A
authors: Bajard
authors: Isabelle
authors: I
authors: Ray-Coquard
authors: Jocelyne
authors: J
authors: Provencal
authors: David
authors: D
authors: Coeffic
authors: Cécile
authors: C
authors: Agostini
authors: Martial
authors: M
authors: Boisseau
authors: Régis
authors: R
authors: Kaphan
authors: Dominique
authors: D
authors: Dramais
authors: Corina
authors: C
authors: Oprea
authors: Rose-Marie
authors: RM
authors: Ferri-Dessens
authors: Jean-Paul
authors: JP
authors: Guastalla
authors: David
authors: D
authors: Perol
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D057239:Early Termination of Clinical Trials; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D005472:Fluorouracil