Long-term follow-up of the SBG 9401 study... : Annals of Oncology (original) (raw)

original article: breast cancer

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

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

Annals of Oncology

18

(

4

)

:p

694

-

700

,

April 2007

.

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.