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Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy
Department of Oncology, Karolinska Institutet, Stockholm, Sweden, Radiumhemmet Karolinska Hospital, Stockholm, Sweden.
Radiumhemmet, Karolinska Institutet and University Hospital, Solna, S-171 76 Stockholm, Sweden.
Roche OY, Espoo, Finland, Department of Oncology, University Hospital, Helsinki, Finland.
Southern Norway Regional Health Authority, Skien, Norway, The Norwegian Radiumhospital, Oslo, Norway.
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2007 (English)In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 18, no 4, 694-700 p.Article in journal (Refereed) Published
Abstract [en]

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 theage 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. © 2007 Oxford University Press.

Place, publisher, year, edition, pages
2007. Vol. 18, no 4, 694-700 p.
Keyword [en]
Adjuvant, Breast cancer, Randomised, Tailored chemotherapy
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-49949DOI: 10.1093/annonc/mdl488OAI: diva2:270845
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2010-05-24

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Karlsson, Katarina
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Department of Oncology UHLFaculty of Health SciencesNursing Science
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