Development and independent validation of a prognostic assay for stage ii colon cancer using formalin-fixed paraffin-embedded tissue

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

Research output: Contribution to journalArticlepeer-review

134 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)4620-4626
Number of pages7
JournalJournal of Clinical Oncology
Issue number35
StatePublished - Dec 10 2011

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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