title: Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma.
abstract: BACKGROUND
  The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma.
  
  
  METHODS
  This open-label, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m(2) (intravenous bolus), and docetaxel, 75 mg/m(2) (1-hour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m(2) twice daily, on Days 1-14 of each 3-week treatment cycle.
  
  
  RESULTS
  A total of 67 patients received 392 cycles of treatment, with a median of 6 cycles in patients with Stage III disease (n = 34 patients) and a median of 8 cycles in patients with Stage IV disease (n = 33 patients). The objective response rate was 82%, including complete responses in 21% of patients. A greater proportion of patients with Stage III disease achieved tumor responses compared with patients who had Stage IV disease (97% vs. 67%, respectively). Among 34 patients with Stage III disease, pathologic complete responses were confirmed in 10 patients (29%). TEX chemotherapy demonstrated an acceptable safety profile. There was a low incidence of Grade 3 adverse events, and Grade 4 adverse events were particularly rare (4%). The most common Grade 3-4 adverse event was febrile neutropenia, which occurred in 16% of patients.
  
  
  CONCLUSIONS
  TEX combination therapy has important antitumor activity and an acceptable safety profile in this setting. A large, randomized, Phase III trial is ongoing to compare TEX chemotherapy with an epirubicin plus docetaxel regimen in patients with untreated, advanced breast carcinoma.
authors.affiliation: Divisione di Oncologia Medica, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. marco.venturini@istge.it
authors.forename: Marco
authors.initials: M
authors.lastname: Venturini
authors.forename: Antonio
authors.initials: A
authors.lastname: Durando
authors.forename: Ornella
authors.initials: O
authors.lastname: Garrone
authors.forename: Maria Antonietta
authors.initials: MA
authors.lastname: Colozza
authors.forename: Antonio
authors.initials: A
authors.lastname: Contu
authors.forename: Ilaria
authors.initials: I
authors.lastname: Stevani
authors.forename: Franco
authors.initials: F
authors.lastname: Genta
authors.forename: Claudia
authors.initials: C
authors.lastname: Bighin
authors.forename: Antonio
authors.initials: A
authors.lastname: Lambiase
authors.forename: Lucia
authors.initials: L
authors.lastname: Del Mastro
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil