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Old 12-16-2004, 10:09 PM   #1
Merridithp
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By Thomas S. May

December 8, 2004 — The Amsterdam 70-gene prognostic signature, a relatively new risk assessment tool developed by scientists in The Netherlands, can predict time to distant metastases (TDM) and overall survival (OS) in node-negative, untreated breast cancer with greater accuracy than other tools currently being used, such as the Nottingham Prognostic Index (NPI) and the St-Gallen criteria, according to a multicenter external validation study presented today at the 27th San Antonio Breast Cancer Symposium.

To validate this new method, the researchers analyzed frozen archival tumor material from node-negative patients younger than 60 years of age, diagnosed before or during 1998, and receiving only locoregional therapy at 6 cancer centers. The 70-gene prognostic signature was obtained using current gene expression profiling techniques.

Tissue samples were classified as indicating "high risk" or "low risk" based on gene signatures, and were subsequently compared with clinical outcomes of patients who were also classified into high- and low-risk groups based on hazard ratios. Clinical risk groups were determined by an independent statistical office in Brussels.

Cross-classification of clinical vs genetic risk groups revealed discordant results for 33% of patients in the low gene signature risk group and 36% discordance in the high gene signature risk group. These data compare favorably with results obtained using both the NPI (36% and 54% discordance for the low- and high-risk groups, respectively) and the St-Gallen criteria (35% and 43% discordance). Furthermore, the 70-gene prognostic signature outperformed both the NPI and the St-Gallen criteria in predicting TDM and overall survival.

The investigators concluded that their study validated the Amsterdam 70-gene signature as an independent predictor of outcome in untreated node-negative breast cancer patients. "Our results give the rationale to move forward to a large-scale, prospective randomized clinical trial, designed to demonstrate the gene signature's utility," the researchers stated.

http://clinicaloptions.com/onco/news/news_SABCS_38.asp
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