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Imaging, Diagnosis, Prognosis |
Authors' Affiliations: 1 Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; 2 International Drug Development Institute, and 3 Machine Learning Group, Université Libre de Bruxelles, Brussels, Belgium; 4 Veridex LLC, a Johnson & Johnson Company, San Diego, California; 5 European Institute of Oncology and University of Milan School of Medicine, Milan, Italy; 6 National Center of Competence in Research Molecular Oncology, Swiss Institute of Experimental Cancer Research, Epalinges and the Swiss Institute of Bioinformatics, Lausanne, Switzerland; 7 Institut Gustave Roussy, Villejuif, France; 8 Karolinska Institute, Stockholm, Sweden; 9 Centre René Huguenin and Institut National de la Santé et de la Recherche Médicale, Saint-Cloud, France; 10 Guy's Hospital, London, United Kingdom; 11 John Radcliffe Hospital, Oxford, United Kingdom; and 12 Erasmus Medical Center/Daniel den Hoed Cancer Center, Rotterdam, the Netherlands
Requests for reprints: Breast International Group/TRANSBIG Secretariat, Institut Jules Bordet, 121 Boulevard de Waterloo, 1000 Brussels, Belgium. Phone: 32-2-5413526; Fax: 32-2-5413199; E-mail: TRANSBIG{at}bordet.be.
Purpose: Recently, a 76-gene prognostic signature able to predict distant metastases in lymph node–negative (N–) breast cancer patients was reported. The aims of this study conducted by TRANSBIG were to independently validate these results and to compare the outcome with clinical risk assessment.
Experimental Design: Gene expression profiling of frozen samples from 198 N– systemically untreated patients was done at the Bordet Institute, blinded to clinical data and independent of Veridex. Genomic risk was defined by Veridex, blinded to clinical data. Survival analyses, done by an independent statistician, were done with the genomic risk and adjusted for the clinical risk, defined by Adjuvant! Online.
Results: The actual 5- and 10-year time to distant metastasis were 98% (88-100%) and 94% (83-98%), respectively, for the good profile group and 76% (68-82%) and 73% (65-79%), respectively, for the poor profile group. The actual 5- and 10-year overall survival were 98% (88-100%) and 87% (73-94%), respectively, for the good profile group and 84% (77-89%) and 72% (63-78%), respectively, for the poor profile group. We observed a strong time dependence of this signature, leading to an adjusted hazard ratio of 13.58 (1.85-99.63) and 8.20 (1.10-60.90) at 5 years and 5.11 (1.57-16.67) and 2.55 (1.07-6.10) at 10 years for time to distant metastasis and overall survival, respectively.
Conclusion: This independent validation confirmed the performance of the 76-gene signature and adds to the growing evidence that gene expression signatures are of clinical relevance, especially for identifying patients at high risk of early distant metastases.
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