Journal article

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

Amir Sonnenblick, Prudence A Francis, Hatem A Azim, Evandro de Azambuja, Bo Nordenskjold, Jorge Gutierez, Emmanuel Quinaux, Mauro G Mastropasqua, Lieveke Ameye, Michael Anderson, Ana Lluch, Michael Gnant, Aron Goldhirsch, Angelo Di Leo, Agusti Barnadas, Hernan Cortes-Funes, Martine Piccart, John Crown



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 2×2 trial design to one of four treatments. The primary objective was to evaluate the overall efficacy of docetaxel on disease free survi..

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Funding Acknowledgements

BIG 2-98 was conducted under the umbrella of the Breast international group (BIG), with sponsorship and funding provided by Sanofi Aventis. TransTAX analyses were funded by Associazione Italiana Ricerca Cancro (AIRC), Milan, Italy. The coordinating group and data centre was the Breast European Adjuvant Studies Team (BrEAST), and eight BIG cooperative groups participated in the study.