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

Wilking, N.; Lidbrink, E.; Wiklund, T.; Erikstein, B.; Lindman, H.; Malmström, Per LU ; Kellokumpu-Lehtinen, P.; Bengtsson, N. -O.; Soederlund, G. and Anker, G., et al. (2007) In Annals of Oncology 18(4). p.694-700
Abstract
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... (More)
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. (Less)
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publication status
published
subject
keywords
adjuvant, tailored chemotherapy, randomised, breast cancer
in
Annals of Oncology
volume
18
issue
4
pages
694 - 700
publisher
Oxford University Press
external identifiers
  • wos:000245349500013
  • scopus:34047161056
ISSN
1569-8041
DOI
10.1093/annonc/mdl488
language
English
LU publication?
yes
id
3574ec13-af1d-46ee-a05a-eaab584bbe9e (old id 670294)
date added to LUP
2007-12-19 08:58:44
date last changed
2017-09-24 04:22:26
@article{3574ec13-af1d-46ee-a05a-eaab584bbe9e,
  abstract     = {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.},
  author       = {Wilking, N. and Lidbrink, E. and Wiklund, T. and Erikstein, B. and Lindman, H. and Malmström, Per and Kellokumpu-Lehtinen, P. and Bengtsson, N. -O. and Soederlund, G. and Anker, G. and Wist, E. and Ottosson, S. and Salminen, E. and Ljungman, P. and Holte, H. and Nilsson, J. and Blomqvist, C. and Bergh, J.},
  issn         = {1569-8041},
  keyword      = {adjuvant,tailored chemotherapy,randomised,breast cancer},
  language     = {eng},
  number       = {4},
  pages        = {694--700},
  publisher    = {Oxford University Press},
  series       = {Annals of Oncology},
  title        = {Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy},
  url          = {http://dx.doi.org/10.1093/annonc/mdl488},
  volume       = {18},
  year         = {2007},
}