Company plans to develop a prognostic tool with data obtained from these studies and future research.

Genomic Health reported the results of two studies, which found genes that could help predict the likelihood of recurrence of and chemotherapy benefit for early-stage colon cancer.

The first report evaluated colon cancers from patients treated with surgery alone, including 270 volunteers from the National Surgical Adjuvant Breast & Bowel Project (NSABP) C-01/C-02 study and 765 people were treated at the Cleveland Clinic. Researchers found 65 genes significantly associated with colon cancer recurrence across both patient populations. The range of individual gene expression was associated with an up to 11-fold difference in the risk of disease recurrence, according to Genomic Health.

The second study analyzed colon cancers from an additional 508 patients who were treated with surgery plus 5-FU/LV chemotherapy in the NSABP study C-06. The investigators discovered 56 genes that were significantly associated with disease prognosis for stage II and III colon cancer in this study as well as in patients treated with surgery alone in the NSABP C-01/C-02 and at the Cleveland Clinic.

The scientists also used 15 of the 56 genes as a preliminary model to stratify patients into recurrence-risk categories.
Overall, Genomic Health has completed four independent studies involving 1,851 colon cancer patients to evaluate a total of 761 genes. This data will support the selection of the final gene set.

“This marks an important step in our effort to develop a test to personalize treatment decisions for early-stage colon cancer patients using the same rigorous clinical development and validation process as we did with Oncotype DX for breast cancer,”  says Steven Shak, M.D., CMO.

The results of the studies were presented  on January 26 at “ASCO GI” in Orlando, FL.

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