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

2011; Lippincott Williams & Wilkins; Volume: 29; Issue: 35 Linguagem: Inglês

10.1200/jco.2011.35.4498

1527-7755

Richard D. Kennedy, Max Bylesjö, Peter Kerr, Timothy S. Davison, Julie M. Black, Elaine W. Kay, Robert J. Holt, Vitali Proutski, Miika Ahdesmäki, Vadim Farztdinov, Nicolas Goffard, Peter Hey, Fionnuala A. McDyer, Karl Mulligan, Julie Mussen, Eamonn O’Brien, Gavin R. Oliver, Steven M. Walker, Jude M. Mulligan, Claire Wilson, Andreas Winter, Diarmuid P. O’Donoghue, Hugh Mulcahy, Jacintha O’Sullivan, Kieran Sheahan, John Hyland, Rajiv Dhir, Oliver F. Bathe, Ola Winqvist, Upender Manne, Chandrakumar Shanmugam, Sridhar Ramaswamy, Erick Calderon Leon, William I. Smith, Ultan McDermott, Richard H. Wilson, Daniel B. Longley, John L. Marshall, Robert Cummins, Daniel J. Sargent, Patrick G. Johnston, D. Paul Harkin,

Genetic factors in colorectal cancer

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.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.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).This gene signature represents a novel prognostic biomarker for patients with stage II colon cancer that can be applied to FFPE tumor samples.