title: Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial.
abstract: OBJECTIVE
  The PACS 01 trial compared six cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with a sequential regimen of three cycles of FEC followed by three cycles of docetaxel (FEC-D) as adjuvant treatment for women with node-positive early breast cancer.
  
  
  METHODS
  Between June 1997 and March 2000, 1,999 patients with operable node-positive breast cancer were randomly assigned to either FEC every 21 days for six cycles, or three cycles of FEC followed by three cycles of docetaxel, both given every 21 days. Hormone-receptor-positive patients received tamoxifen for 5 years after chemotherapy. The primary end point was 5-year disease-free survival (DFS).
  
  
  RESULTS
  Median follow-up was 60 months. Five-year DFS rates were 73.2% with FEC and 78.4% with FEC-D (unadjusted P = .011; adjusted P = .012). Multivariate analysis adjusted for prognostic factors showed an 18% reduction in the relative risk of relapse with FEC-D. Five-year overall survival rates were 86.7% with FEC and 90.7% with FEC-D, demonstrating a 27% reduction in the relative risk of death (unadjusted P = .014; adjusted P = .017). The incidence of grade 3 to 4 neutropenia, the need for hematopoietic growth factor, and incidence of nausea/vomiting were higher with FEC. Docetaxel was associated with more febrile neutropenia in the fourth cycle, stomatitis, edema, and nail disorders. Though rare overall, there were fewer cardiac events after FEC-D (P = .03), attributable mainly to the lower anthracycline cumulative dose.
  
  
  CONCLUSIONS
  Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free and overall survival in node-positive breast cancer patients and has a favorable safety profile.
authors.affiliation: Department of Medical Oncology, Institut Claudius Régaud, Toulouse, France. roche.henri@claudiusregaud.fr
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Pierre
authors.initials: P
authors.lastname: Fumoleau
authors.forename: Marc
authors.initials: M
authors.lastname: Spielmann
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Canon
authors.forename: Thierry
authors.initials: T
authors.lastname: Delozier
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Michel
authors.initials: M
authors.lastname: Symann
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Patrick
authors.initials: P
authors.lastname: Soulié
authors.forename: Françoise
authors.initials: F
authors.lastname: Eichler
authors.forename: Patrice
authors.initials: P
authors.lastname: Viens
authors.forename: Alain
authors.initials: A
authors.lastname: Monnier
authors.forename: Anita
authors.initials: A
authors.lastname: Vindevoghel
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Marie-Josèphe
authors.initials: MJ
authors.lastname: Goudier
authors.forename: Jacques
authors.initials: J
authors.lastname: Bonneterre
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Martin
authors.forename: Jean
authors.initials: J
authors.lastname: Genève
authors.forename: Bernard
authors.initials: B
authors.lastname: Asselain
mesh_terms: D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D013629:Tamoxifen / Q000627:therapeutic use; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil