title: Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy.
abstract: BACKGROUND
  The purpose was to investigate adjuvant marrow-supportive high-dose chemotherapy compared with an equitoxicity-tailored comparator arm.
  
  
  METHODS
  Five hundred and twenty-five women below the age of 60 years with operated high-risk primary breast cancer were randomised to nine cycles of granulocyte colony-stimulating factor supported and individually tailored FEC (5-fluorouracil, epirubicin, cyclophosphamide), (n = 251) or standard FEC followed by marrow-supported high-dose therapy with CTCb (cyclophosphamide, thiotepa, carboplatin) therapy (n = 274), followed by locoregional radiotherapy and tamoxifen for 5 years.
  
  
  RESULTS
  There were 104 breast cancer relapses in the tailored FEC group versus 139 in the CTCb group (double triangular method by Whitehead, P = 0.046), with a median follow-up of all included patients of 60.8 months. The event-free survival demonstrated 121 and 150 events in the tailored FEC- and CTCb group, respectively [P = 0.074, hazard ratio (HR) 0.804, 95% confidence interval (CI) 0.633-1.022]. Ten patients in the tailored FEC regimen developed acute myeloid leukaemia (AML)/myelodysplasia (MDS). One hundred deaths occurred in the tailored FEC group and 121 in the CTCb group (P = 0.287, HR 0.866, 95% CI 0.665-1.129).
  
  
  CONCLUSIONS
  The update of this study shows an improved outcome linked to the tailored FEC treatment in relation to breast cancer relapse, but also an increased incidence of AML/MDS.
authors.affiliation: Department of Oncology, Karolinska Institutet, S-171 76 Stockholm, Sweden.
authors.forename: N
authors.initials: N
authors.lastname: Wilking
authors.forename: E
authors.initials: E
authors.lastname: Lidbrink
authors.forename: T
authors.initials: T
authors.lastname: Wiklund
authors.forename: B
authors.initials: B
authors.lastname: Erikstein
authors.forename: H
authors.initials: H
authors.lastname: Lindman
authors.forename: P
authors.initials: P
authors.lastname: Malmström
authors.forename: P
authors.initials: P
authors.lastname: Kellokumpu-Lehtinen
authors.forename: N-O
authors.initials: NO
authors.lastname: Bengtsson
authors.forename: G
authors.initials: G
authors.lastname: Söderlund
authors.forename: G
authors.initials: G
authors.lastname: Anker
authors.forename: E
authors.initials: E
authors.lastname: Wist
authors.forename: S
authors.initials: S
authors.lastname: Ottosson
authors.forename: E
authors.initials: E
authors.lastname: Salminen
authors.forename: P
authors.initials: P
authors.lastname: Ljungman
authors.forename: H
authors.initials: H
authors.lastname: Holte
authors.forename: J
authors.initials: J
authors.lastname: Nilsson
authors.forename: C
authors.initials: C
authors.lastname: Blomqvist
authors.forename: J
authors.initials: J
authors.lastname: Bergh
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016190:Carboplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D013852:Thiotepa / Q000008:administration & dosage
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D003520:Cyclophosphamide; D013852:Thiotepa; D016190:Carboplatin; D005472:Fluorouracil