Validation of a 12-Gene Colon Cancer Recurrence Score® in

Stage II Colon Cancer Patients from CALGB 9581

A.P. Venook1, D. Niedzwiecki2, M. Lopatin3, M. Lee3, P. N. Friedman4, W. Frankel5, K. Clark-Langone3, C. Yoshizawa3, C. Millward3, S. Shak3, R. M. Goldberg6, N. N. Mahmoud7, R. L.

Schilsky4, M. M. Bertagnolli8

 1. University of California, San Francisco, San Francisco, CA; 2. Duke University, Durham, NC; 3. Genomic Health, Redwood City, CA; 4. The University of Chicago, Chicago, IL; 5. The Ohio State

University, Columbus, OH; 6. University of North Carolina at Chapel Hill, Chapel Hill, NC; 7. University of Pennsylvania, Philadelphia, PA; 8. Brigham and Women's Hospital, Boston, MA

Venook AP, et al. ASCO 2011. Abstract 3518 (poster presentation).

2

CALGB 9581: A Unique Opportunity to Test the Oncotype DX® Assay in Low/Standard Risk

Stage II Colon Cancer

• Sampling design with 690 evaluable patients, including 162 recurrence events, representative of 1,672 stage II colon cancer patients from CALGB 9581

• A population where risk discrimination is challenging with conventional clinical and pathologic factors

Venook AP, et al. ASCO 2011. Abstract 3518 (poster presentation).

3

CALGB 9581: Second Successful Prospectively-Designed Confirmation Study

Venook AP, et al. ASCO 2011. Abstract 3518 (poster presentation).

RS, Recurrence Score®

4

CALGB 9581: Improving the Ability to Discriminate High vs. Low Risk of Recurrence

in Standard Risk Stage II Colon Cancer

Venook AP, et al. ASCO 2011. Abstract 3518 (poster presentation).

RS, Recurrence Score®