• Marc J van de Vijver, Yudong D He, Laura J van't Veer, Hongyue Dai, Augustinus A M Hart, Dorien W Voskuil, George J Schreiber, Johannes L Peterse, Chris Roberts, Matthew J Marton, Mark Parrish, Douwe Atsma, Anke Witteveen, Annuska Glas, Leonie Delahaye, Tony van der Velde, Harry Bartelink, Sjoerd Rodenhuis, Emiel T Rutgers, Stephen H Friend, and René Bernards.
• Division of Diagnostic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
• N. Engl. J. Med. 2002 Dec 19; 347 (25): 1999-2009.

BackgroundA more accurate means of prognostication in breast cancer will improve the selection of patients for adjuvant systemic therapy.MethodsUsing microarray analysis to evaluate our previously established 70-gene prognosis profile, we classified a series of 295 consecutive patients with primary breast carcinomas as having a gene-expression signature associated with either a poor prognosis or a good prognosis. All patients had stage I or II breast cancer and were younger than 53 years old; 151 had lymph-node-negative disease, and 144 had lymph-node-positive disease. We evaluated the predictive power of the prognosis profile using univariable and multivariable statistical analyses.ResultsAmong the 295 patients, 180 had a poor-prognosis signature and 115 had a good-prognosis signature, and the mean (+/-SE) overall 10-year survival rates were 54.6+/-4.4 percent and 94.5+/-2.6 percent, respectively. At 10 years, the probability of remaining free of distant metastases was 50.6+/-4.5 percent in the group with a poor-prognosis signature and 85.2+/-4.3 percent in the group with a good-prognosis signature. The estimated hazard ratio for distant metastases in the group with a poor-prognosis signature, as compared with the group with the good-prognosis signature, was 5.1 (95 percent confidence interval, 2.9 to 9.0; P<0.001). This ratio remained significant when the groups were analyzed according to lymph-node status. Multivariable Cox regression analysis showed that the prognosis profile was a strong independent factor in predicting disease outcome.ConclusionsThe gene-expression profile we studied is a more powerful predictor of the outcome of disease in young patients with breast cancer than standard systems based on clinical and histologic criteria.Copyright 2002 Massachusetts Medical Society

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