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Annals of Oncology Advance Access originally published online on February 13, 2007
Annals of Oncology 2007 18(4):694-700; doi:10.1093/annonc/mdl488
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© 2007 European Society for Medical Oncology

breast cancer

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

N Wilking1, E Lidbrink2, T Wiklund3, B Erikstein4, H Lindman5, P Malmström6, P Kellokumpu-Lehtinen7, N-O Bengtsson8, G Söderlund9, G Anker10, E Wist11, S Ottosson12, E Salminen13, P Ljungman14, H Holte15, J Nilsson16, C Blomqvist17, J Bergh1,2,* On behalf of the Scandinavian Breast Group, study SBG 9401{dagger}

1 Department of Oncology, Karolinska Institutet, Stockholm, Sweden
2 Radiumhemmet, Karolinska Institutet and University Hospital, Stockholm
3 Roche OY, Espoo, Finland
4 Southern Norway Regional Health Authority, Skien, Norway
5 Department of Oncology, Akademiska Hospital, Uppsala, Sweden
6 Department of Oncology, University Hospital, Lund, Sweden
7 Department of Oncology, Tampere University and University Hospital, Finland
8 Department of Oncology, University Hospital, Umeå, Sweden
9 Department of Oncology, University Hospital, Linköping, Sweden
10 Department of Oncology, Haukeland University Hospital, Bergen, Norway
11 Department of Oncology, Ullevål University Hospital and Faculty of Medicine, University of Oslo, Norway
12 Department of Oncology, NÄL, Trollhttan, Sweden
13 Department of Oncology, Turku University Hospital, Finland
14 Haematology Centre, Karolinska University Hospital, Stockholm, Sweden
15 Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway
16 Trial Form Support AB, Stockholm, Sweden
17 Department of Oncology, University Hospital, Helsinki, Finland

* Correspondence to: Dr J. Bergh, Department of Oncology, Radiumhemmet, Karolinska Institutet and University Hospital, Solna, S-171 76 Stockholm, Sweden. Tel: +46-70-484-85-02; Fax: +46-85-177-95-24; E-mail: jonas.bergh{at}ki.se

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.

Key words: adjuvant, breast cancer, randomised, tailored chemotherapy

{dagger} Participants in the SBG 9401 study group are listed in the Appendix.


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