Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue

作者：Kennedy Richard D; Bylesjo Max; Kerr Peter; Davison Timothy; Black Julie M; Kay Elaine W; Holt Robert J; Proutski Vitali; Ahdesmaki Miika; Farztdinov Vadim; Goffard Nicolas; Hey Peter; McDyer Fionnuala; Mulligan Karl; Mussen Julie; O'Brien Eamonn; Oliver Gavin; Walker Steven M; Mulligan Jude M; Wilson Claire; Winter Andreas; O'Donoghue Diarmuid; Mulcahy Hugh; O'Sullivan Jacintha; Sheahan Kieran; Hyland John; Dhir Rajiv; Bathe Oliver F; Winqvist Ola

来源：Journal of Clinical Oncology, 2011, 29(35): 4620-4626.

DOI：10.1200/JCO.2011.35.4498

Purpose
Current prognostic factors are poor at identifying patients at risk of disease recurrence after surgery for stage II colon cancer. Here we describe a DNA microarray-based prognostic assay using clinically relevant formalin-fixed paraffin-embedded (FFPE) samples.
Patients and Methods
A gene signature was developed from a balanced set of 73 patients with recurrent disease (high risk) and 142 patients with no recurrence (low risk) within 5 years of surgery.
Results
The 634-probe set signature identified high-risk patients with a hazard ratio (HR) of 2.62 (P < .001) during cross validation of the training set. In an independent validation set of 144 samples, the signature identified high-risk patients with an HR of 2.53 (P < .001) for recurrence and an HR of 2.21 (P = .0084) for cancer-related death. Additionally, the signature was shown to perform independently from known prognostic factors (P < .001).
Conclusion
This gene signature represents a novel prognostic biomarker for patients with stage II colon cancer that can be applied to FFPE tumor samples.

• 出版日期2011-12-10