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Sökning: onr:"swepub:oai:DiVA.org:liu-120332" > Final 10-year resul...

Final 10-year results of the Breast International Group 2-98 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer

Sonnenblick, Amir (författare)
University of Libre Bruxelles, Belgium
Francis, Prudence A. (författare)
Peter MacCallum Cancer Centre, Australia; Australia and New Zealand Breast Cancer Trials Grp, Australia; Int Breast Cancer Study Grp, Switzerland
Azim, Hatem A. Jr. (författare)
University of Libre Bruxelles, Belgium
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de Azambuja, Evandro (författare)
University of Libre Bruxelles, Belgium
Nordenskjöld, Bo (författare)
Linköpings universitet,Avdelningen för kliniska vetenskaper,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US
Gutierez, Jorge (författare)
Clin Las Condes, Chile
Quinaux, Emmanuel (författare)
Int Institute Drug Dev, Belgium
Mastropasqua, Mauro G. (författare)
University of Milan, Italy; University of Milan, Italy
Ameye, Lieveke (författare)
University of Libre Bruxelles, Belgium
Anderson, Michael (författare)
Copenhagen University Hospital, Denmark; Danish Breast Cancer Cooperat Grp, Denmark
Lluch, Ana (författare)
University of Valencia, Spain
Gnant, Michael (författare)
Medical University of Vienna, Austria; Medical University of Vienna, Austria
Goldhirsch, Aron (författare)
European Institute Oncol, Italy; Int Breast Cancer Study Grp, Switzerland
Di Leo, Angelo (författare)
Hospital Prato, Italy
Barnadas, Agusti (författare)
University of Autonoma Barcelona, Spain
Cortes-Funes, Hernan (författare)
University Hospital 12 Octubre, Spain
Piccart, Martine (författare)
University of Libre Bruxelles, Belgium
Crown, John (författare)
St Vincets University Hospital, Ireland
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 (creator_code:org_t)
Elsevier, 2015
2015
Engelska.
Ingår i: European Journal of Cancer. - : Elsevier. - 0959-8049 .- 1879-0852. ; 51:12, s. 1481-1489
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Aim: Breast International Group (BIG) 2-98 is a randomised phase III trial that tested the effect of adding docetaxel, either in sequence to or in combination with anthracycline-based adjuvant chemotherapy, in women with node-positive breast cancer (BC). Here, we present the 10-year final trial safety and efficacy analyses. We also report an exploratory analysis on the predictive value of Ki67 for docetaxel efficacy, in the BIG 2-98 and using a pooled analysis of three other randomised trials. Patients and methods: 2887 patients were randomly assigned in a 2 x 2 trial design to one of four treatments. The primary objective was to evaluate the overall efficacy of docetaxel on disease free survival (DFS). Secondary objectives included comparisons of sequential docetaxel versus sequential control arm, safety and overall survival (OS). Ki67 expression was centrally evaluated by immunohistochemistry. Results: After a median follow-up of 10.1 years, the addition of docetaxel did not significantly improve DFS or OS (hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.81-1.04; P = 0.16 and HR = 0.88, 95% CI = 0.76-1.03; P = 0.11, respectively). Sequential docetaxel did not improve DFS compared to the sequential control arm (HR = 0.86, 95% CI = 0.721.03; P = 0.10). In oestrogen receptor (ER)-positive tumours with Ki67 greater than= 14%, the addition of docetaxel resulted in 5.4% improvement in 10-year OS (P = 0.03, test for interaction = 0.1). In a multivariate model, there was a trend for improved DFS and OS in ER-positive patients with high Ki67 and treated with docetaxel (HR = 0.79, 95% CI = 0.63-1.01; P = 0.05 and HR = 0.76, 95% CI = 0.57-1.01; P = 0.06, respectively). A pooled analysis of four randomised trials showed a benefit of taxanes in highly proliferative ER-positive disease but not in low proliferating tumours (interaction test P = 0.01). Conclusion: The DFS benefit previously demonstrated with sequential docetaxel is no longer observed at 10 years. However, an exploratory analysis suggested a benefit of docetaxel in patients with highly proliferative ER-positive BC.

Ämnesord

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)

Nyckelord

Ki67; Adjuvant taxanes; ER positive; Breast cancer; Pooled analysis

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