Colon Cancer

^*Note: Validation studies have already been performed on the 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 Colon Cancer Assay (Commercially Available)

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 specific 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

Recent Oncotype DX Colon Cancer Publications and Presentations

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 alterations 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 testing into treatment planning in stage II colon cancer.

Stage II & III 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. Genomic Health is in the process of conducting early development studies to evaluate the Oncotype DX colon cancer test for treatment planning in stage III disease, and we are also conducting studies to investigate our colon cancer test’s ability to predict chemotherapy benefit in stage II and stage III colon cancer patients treated with oxaliplatin. 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), has improved outcomes in patients with metastatic colon cancer but has also increased 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.

Learn more about additional Genomic Health products in development:

• Breast Cancer
• Prostate Cancer
• Non-Small Cell Lung Cancer
• Renal Cancer
• Melanoma

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

• Additional Patient Resources: Oncotype DX colon cancer test website – a detailed website with information for patients, physicians and payors.
  www.oncotypedx.com/colon.aspx
• My Colon Cancer Coach – a free, interactive online tool designed to help men and women with colon cancer better understand their disease and potential treatments. By answering a few simple questions about your cancer, patients will receive a personalized report of treatment options. Visit: www.MyColonCancerCoach.org to learn more.

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.

References for US and Global Incidences of Colon Cancer

1. Mattson Jack, CancerMPact November 2010 (2011 incidence).
2. Company figure adapted from MattsonJack, CancerMpact, November 2010 (2011 incidence).