title: Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: final analysis of the randomized FinXX trial.
abstract: OBJECTIVE
  Capecitabine is an active agent in the treatment of breast cancer. It is not known whether integration of capecitabine into an adjuvant regimen that contains a taxane, an anthracycline, and cyclophosphamide improves outcome in early breast cancer.
  
  
  METHODS
  Women with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive either three cycles of docetaxel and capecitabine (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX; n = 753) or three cycles of docetaxel (T) followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF; n = 747). The primary end point was recurrence-free survival (RFS).
  
  
  RESULTS
  During a median follow-up time of 59 months, 214 RFS events occurred (local or distant recurrences or deaths; TX/CEX, n = 96; T/CEF, n = 118). RFS was not significantly different between the groups (hazard ratio [HR], 0.79; 95% CI, 0.60 to 1.04; P = .087; 5-year RFS, 86.6% for TX/CEX v 84.1% for T/CEF). Fifty-six patients assigned to TX/CEX died during the follow-up compared with 75 of patients assigned to T/CEF (HR, 0.73; 95% CI, 0.52 to 1.04; P = .080). In exploratory analyses, TX/CEX improved breast cancer-specific survival (HR, 0.64; 95% CI, 0.44 to 0.95; P = .027) and RFS in women with triple-negative disease and in women who had more than three metastatic axillary lymph nodes at the time of diagnosis. We detected little severe late toxicity.
  
  
  CONCLUSIONS
  Integration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine.
authors: Department of Oncology, Helsinki University Central Hospital, Haartmaninkatu 4, PO Box 180, FIN-00029 Helsinki, Finland. heikki.joensuu@hus.fi
authors: Heikki
authors: H
authors: Joensuu
authors: Pirkko-Liisa
authors: PL
authors: Kellokumpu-Lehtinen
authors: Riikka
authors: R
authors: Huovinen
authors: Arja
authors: A
authors: Jukkola-Vuorinen
authors: Minna
authors: M
authors: Tanner
authors: Riitta
authors: R
authors: Kokko
authors: Johan
authors: J
authors: Ahlgren
authors: Päivi
authors: P
authors: Auvinen
authors: Outi
authors: O
authors: Paija
authors: Leena
authors: L
authors: Helle
authors: Kenneth
authors: K
authors: Villman
authors: Paul
authors: P
authors: Nyandoto
authors: Greger
authors: G
authors: Nilsson
authors: Marjo
authors: M
authors: Pajunen
authors: Raija
authors: R
authors: Asola
authors: Paula
authors: P
authors: Poikonen
authors: Mika
authors: M
authors: Leinonen
authors: Vesa
authors: V
authors: Kataja
authors: Petri
authors: P
authors: Bono
authors: Henrik
authors: H
authors: Lindman
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D000069287:Capecitabine; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000473:pathology; D018275:Carcinoma, Lobular / Q000188:drug therapy / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005387:Finland; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008408:Mastectomy / Q000379:methods; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011446:Prospective Studies; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D014408:Biomarkers, Tumor; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D003520:Cyclophosphamide; D005472:Fluorouracil