title: Extended benefit from sequential administration of docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide regimen for node-positive breast cancer: the 8-year follow-up results of the UNICANCER-PACS01 trial.
abstract: OBJECTIVE
  The initial report from the Programme Action Concertée Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2)) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years.
  
  
  METHODS
  Between June 1997 and March 2000, a total of 1,999 patients (age <65) with localized, resectable, non-pretreated, unilateral breast cancer were randomly assigned to receive either standard FEC100 for 6 cycles or 3 cycles of FEC100 followed by 3 cycles of 100 mg/m(2) docetaxel (FEC-D), both given every 21 days. Radiotherapy was mandatory after conservative surgery and tamoxifen was given for 5 years to hormone receptor (HR)-positive patients. Five-year DFS was the trial's main endpoint. Updated 8-year survival data are presented.
  
  
  RESULTS
  With a median follow-up of 92.8 months, 639 patients experienced at least one event. A total number of 383 deaths were registered. Eight-year DFS rates were 65.8% with FEC alone and 70.2% with FEC-D. OS rates at 8 years were 78% with FEC alone and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse and a 25% reduction in the relative risk of death in favor of FEC-D. Significant relative risk reductions were observed in the HR-positive, HER2-positive, and Ki67 ≥20% subpopulations.
  
  
  CONCLUSIONS
  Benefits for DFS and OS rates with the sequential FEC-D regimen are fully confirmed at 8 years.
authors.affiliation: Centre Georges-François Leclerc, Dijon, France. bcoudert@cgfl.fr
authors.forename: Bruno
authors.initials: B
authors.lastname: Coudert
authors.forename: Bernard
authors.initials: B
authors.lastname: Asselain
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Marc
authors.initials: M
authors.lastname: Spielmann
authors.forename: Jean-Pascal
authors.initials: JP
authors.lastname: Machiels
authors.forename: Frédérique
authors.initials: F
authors.lastname: Pénault-Llorca
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Christelle
authors.initials: C
authors.lastname: Lévy
authors.forename: Gilles
authors.initials: G
authors.lastname: Romieu
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Canon
authors.forename: Hubert
authors.initials: H
authors.lastname: Orfeuvre
authors.forename: Gilles
authors.initials: G
authors.lastname: Piot
authors.forename: Thierry
authors.initials: T
authors.lastname: Petit
authors.forename: Guy
authors.initials: G
authors.lastname: Jerusalem
authors.forename: Bruno
authors.initials: B
authors.lastname: Audhuy
authors.forename: Corinne
authors.initials: C
authors.lastname: Veyret
authors.forename: Marc
authors.initials: M
authors.lastname: Beauduin
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Eymard
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Martin
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil