Colon Cancer

*Note: Validation studies have already been performed on the 12-gene Oncotype DX Colon Cancer Assay which is commercially available for newly diagnosed patients with stage II colon cancer. For detailed information about Oncotype DX, please call: (866) ONCOTYPE or visit www.oncotypedx.com

Oncotype 12 Gene Colon Cancer Assay

New Targets in Development: Mismatch Repair (MMR) Deficiency/Microsatellite Instability (MSI): Development stage
Stage II & III oxaliplatin benefit: Development stage

Targeted therapy benefit (e.g., EGFR and angiogenesis targeted drugs): Development stage
U.S. Incidence of Colon Cancer 105,000/Year (All stages)1
Global Incidence of Colon Cancer 740,000/Year (All stages)2

About Colon Cancer

In the Western world, colorectal cancer (including colon cancer) is the third most common form of cancer. Mushroom-like non-cancerous growths called polyps are often a precursor to colon cancer. Diagnosis of colon cancer is frequently made via colonoscopy. Current colon cancer treatment includes surgery, followed in many cases by adjuvant chemotherapy. For stage II colon cancer (where there is no tumor involvement of the lymph nodes), only a small percentage of these patients actually benefit from chemotherapy. Current colon cancer treatment selection is based on an assessment of recurrence risk; however, only a limited set of clinical and pathologic markers have been available until now. In the absence of an accurate assessment of colon cancer recurrence, it is difficult to identify which stage II colon cancer patients should be treated more aggressively with chemotherapy.

About the Oncotype DX Colon Cancer Test

Genomic Health's Oncotype DX colon cancer assay is an advanced diagnostic test that has been validated for the assessment of risk of recurrence following surgery in stage II colon cancer patients. This multigene test examines a colon cancer patient's tumor at a molecular level, in order to provide information about the individual biology of each tumor. Oncotype DX does this by evaluating 12 genes within the colon tumor to determine the likelihood that the cancer cells will spread and thus cause colon cancer recurrence following surgical resection. The information provided by Oncotype DX has been shown to have independent value beyond currently used measures for determining colon cancer recurrence risk. For people recently diagnosed with Stage II colon cancer, the Oncotype DX test may be an appropriate part of treatment planning. For detailed information about the Oncotype DX colon cancer assay, please call: (866) ONCOTYPE or visit www.oncotypedx.com

About Genomic Health's Colon Cancer Products in Development

Unlike in breast cancer, there are few established biomarkers in stage II colon cancer to assess risk and guide treatment decisions. Deficiencies in DNA mismatch repair (MMR) gene function, either due to decreased gene expression or mutation, results in the accumulation of DNA alternations which can be manifest as abnormal shortening or lengthening of microsatellite DNA sequences, also known as Microsatellite Instability (MSI). Patients with MMR deficient (MMR-D) colon tumors have been shown to have significantly lower colon cancer recurrence risk, and thus MMR testing can be complementary to the information provided by the Oncotype DX colon cancer assay. Genomic Health is working to facilitate the incorporation of MMR/MSI testing into treatment planning in stage II colon cancer.

Stage II Colon Cancer - Commonly Used Adjuvant Therapies

For stage II and III colon cancer, the most commonly used adjuvant therapies involve combinations of fluoropyrimidines and oxaliplatin. Oxaliplatin is known to produce significant toxicities, including the potential for long-term sensory nerve damage. As such, methods to identify the likelihood of benefit of oxaliplatin are greatly needed to guide the optimal use of this drug. The development of newer targeted therapies, such as cetuximab, which targets the epidermal growth factor receptor (EGFR), and bevacizumab, which targets the vascular endothelial growth factor (VEGF), offers promise for improved outcomes in colon cancer but will likely further increase the complexity of treatment planning for these patients. In May 2008, Genomic Health announced results from a study, in collaboration with Bristol-Myers Squibb (BMS)® and Imclone®, identifying a small number of genes that could predict response to Erbitux®. These results, suggest that quantitative expression of a number of these identified genes used in conjunction with KRAS mutation status, increases the ability to predict which patients might benefit from colon cancer treatment with Erbitux over KRAS status alone. Additional studies are planned to confirm these findings and to develop new multigene tests to guide the use of specific treatment therapies in colon cancer.

For more information about stage II colon cancer and colon cancer treatment options, visit the National Cancer Institute´s Colon Cancer page or the non-profit Colorectal Cancer Coalition Website.

Learn more about additional Genomic Health products in development:

Contact Genomic Health for more information about the Oncotype DX colon cancer test.

References for US and Global Incidences of Colon Cancer

  1. Mattson Jack, CancerMPact August 2009 (2010 incidence).
  2. Company figure adapted from MattsonJack, CancerMpact, August 2009 (2010 incidence)