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Genomic Health's Oncotype DX(R) Colon Cancer Test Predicts Individualized Recurrence Risk for Stage II Colon Cancer Patients
Date:5/14/2009

markers to determine likelihood of recurrence risk are limited in today's clinical setting," said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford. "With these results we have a validated multi-gene test to predict colon cancer recurrence that, when available, will enable physicians to better select patients for aggressive treatment beyond surgery."

David Kerr, Richard Gray, Ph.D., professor of medical statistics at the University of Birmingham, and Philip Quirke, B.M., M.D. FRCPath, professor of pathology and tumor biology at the University of Leeds, are the principal investigators of the QUASAR validation study.

A second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater proportional benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery was not met (p=0.19).

"The positive findings from the QUASAR validation study strongly support a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of three measures, Recurrence Score, MMR/MSI and T-stage," said Steve Shak, M.D., chief medical officer of Genomic Health. "We believe the Oncotype DX colon cancer Recurrence Score will provide the greatest clinical utility for treatment selection in the more than 70 percent of patients for whom MMR/MSI and T-stage are uninformative."

The Oncotype DX colon cancer Recurrence Score maintained its independent significance in predicting the likelihood of recurrence risk (p=0.008), when analyzed in the presence of all the other factors. T4 stage (p=0.005) and MMR deficiency (p<0.001) were also independently beneficial in predicting recurrence, and together comprise approximately 25 percent of patients. T4 stage indicates growth of the tumor through the wall of the bowel and is associated with higher risk of recurrenc
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