title: A phase III adjuvant randomised trial of 6 cycles of 5-fluorouracil-epirubicine-cyclophosphamide (FEC100) versus 4 FEC 100 followed by 4 Taxol (FEC-T) in node positive breast cancer patients (Trial B2000).
abstract: BACKGROUND
  Standard adjuvant chemotherapy regimens for patients with node positive (N+) breast cancer consisted of anthracycline followed by taxane. The European Association for Research in Oncology embarked in 2000 on a phase III trial comparing 6 cycles of FEC100 versus 4 FEC100 followed by 4 Taxol. Primary end-point was disease free survival. Secondary end-points were overall survival, local recurrence free interval, metastases free interval and safety.
  
  
  METHODS
  Between March 2000 and December 2002, 837 patients were randomised between 6FEC100 for 6 cycles (417patients) or FEC100 for 4 cycles then Taxol 175mg/m(2)/3 weeks for 4 cycles (4FEC100-4T) (420 patients). One thousand patients had been planned initially but the trial was closed earlier due to slow accrual.
  
  
  RESULTS
  Hazard ratios (HRs) were 0.99 for disease-free survival (DFS) (95%CI: 0.77-1.26; p=0.91), and 0.85 for overall survival (OS) (95%CI: 0.62-1.15; p=0.29). Nine-year DFS were 62.9% versus 62.5% for 6FEC100 and 4FEC100-4T, respectively. Nine-year OS were 73.9% versus 77% for 6FEC100 and 4FEC100-4T, respectively. Toxicity analyses based on 803 evaluable patients showed that overall grade 3-4 toxicities were similar in both arms (63% versus 58% for 6FEC100 arm and 4FEC100-4T arm, respectively; p=0.16).
  
  
  CONCLUSIONS
  In this trial replacing the last 2 FEC100 cycles of 6FEC100 regimen by 4 Taxol does not lead to a discernable DFS or OS advantage. The lack of a significant difference between the randomised treatment arms may however be due to a lack of power of this trial to detect small, yet clinically worthwhile, treatment benefits.
authors.affiliation: Service de Cancérologie, Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, France. Electronic address: cdelbaldo@hopital-dcss.org.
authors.forename: C
authors.initials: C
authors.lastname: Delbaldo
authors.affiliation: Clinique St Catherine, Avignon, France.
authors.forename: D
authors.initials: D
authors.lastname: Serin
authors.affiliation: CHU Grenoble, France.
authors.forename: M
authors.initials: M
authors.lastname: Mousseau
authors.affiliation: Clinique St Clotilde, La Réunion, France.
authors.forename: S
authors.initials: S
authors.lastname: Greget
authors.affiliation: Hôpital Pasteur, Colmar, France.
authors.forename: B
authors.initials: B
authors.lastname: Audhuy
authors.affiliation: Service Onco-Hématologie, Centre Hospitalier Départemental, La Roche Sur Yon, France.
authors.forename: F
authors.initials: F
authors.lastname: Priou
authors.affiliation: Clinique St Marguerite, Hyères, France.
authors.forename: J F
authors.initials: JF
authors.lastname: Berdah
authors.affiliation: Centre Azuréen de Cancérologie, Mougins, France.
authors.forename: E
authors.initials: E
authors.lastname: Teissier
authors.affiliation: Polyclinique de Blois, La Chaussée St Victor, France.
authors.forename: P
authors.initials: P
authors.lastname: Laplaige
authors.affiliation: Service de Cancérologie, Hôpital Avicennes, Hôpitaux Universitaires Paris-Seine-Saint Denis, France.
authors.forename: L
authors.initials: L
authors.lastname: Zelek
authors.affiliation: International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Quinaux
authors.affiliation: International Development Drug Institute (IDDI), Louvain-la-Neuve, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Buyse
authors.affiliation: Service d'Oncologie Médicale, Hôpital Henri Mondor, Créteil, France.
authors.forename: P
authors.initials: P
authors.lastname: Piedbois
mesh_terms: D000328:Adult; D000368:Aged; 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 / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil
keywords: Adjuvant chemotherapy; Anthracycline; Breast cancer; Efficacy; Paclitaxel; Phase III