Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy

Research output: Contribution to journalArticle


Background: The purpose was to investigate adjuvant marrow-supportive high-dose chemotherapy compared with an equitoxicity-tailored comparator arm. Patients and 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). Conclusion: 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.


  • N. Wilking
  • E. Lidbrink
  • T. Wiklund
  • B. Erikstein
  • H. Lindman
  • Per Malmström
  • P. Kellokumpu-Lehtinen
  • N. -O. Bengtsson
  • G. Soederlund
  • G. Anker
  • E. Wist
  • S. Ottosson
  • E. Salminen
  • P. Ljungman
  • H. Holte
  • J. Nilsson
  • C. Blomqvist
  • J. Bergh
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology


  • adjuvant, tailored chemotherapy, randomised, breast cancer
Original languageEnglish
Pages (from-to)694-700
JournalAnnals of Oncology
Issue number4
Publication statusPublished - 2007
Publication categoryResearch