*Note: Validation studies have been performed and reported on the Oncotype DX® Colon Cancer Assay for patients newly diagnosed with stage II and stage III colon cancer.
The colon cancer test is currently commercially available. For detailed information about Oncotype DX tests, please call: (866) ONCOTYPE or visit www.oncotypedx.com
|New Targets in Development:
||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
||102,000/Year (All stages)1
|Global Incidence of Colon Cancer
||740,000/Year (All stages)2
About Colon Cancer
In the United States colorectal cancer (including colon cancer) is the fourth most prevalent cancer and is second only to lung cancer as a cause of cancer-related mortality3. Mushroom-like non-cancerous growths called polyps are often a precursor to colon cancer. Diagnosis of colon cancer is frequently made via colonoscopy.
Current stage II and III colon cancer treatment includes surgery, followed in many cases by adjuvant chemotherapy.
- Adjuvant chemotherapy in stage II colon cancer (where there is no tumor involvement of the lymph nodes) benefits only a small percentage of patients4. Historically, treatment selection was based primarily on recurrence risk as assessed by clinical and pathologic markers that do not quantify individual patient recurrence risk. In the absence of individual assessment information of risk of colon cancer returning, it has been difficult to make treatment decisions regarding which stage II colon cancer patients should receive more or less aggressive treatment regimens.
- For patients with stage III colon cancer (where there is tumor involvement of the lymph nodes), current practice guidelines recommend 5-FU/LV + oxaliplatin for adjuvant therapy5. However, oxaliplatin benefits only a small percentage of patients and is associated with significant toxicity, including long-term peripheral neuropathies that may be debilitating. Previously used conventional clinical and pathologic risk factors do not adequately discriminate risk and expected absolute benefit of the addition to oxaliplatin to standard chemotherapy treatment regimens.
About the Oncotype DX Colon Cancer Test
Genomic Health's Oncotype DX Colon Cancer Assay is an advanced diagnostic test that has been clinically validated for the assessment of risk of recurrence in stage II and stage III colon cancer from three prospectively-designed studies 6, 7, 8. 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. The Oncotype DX test 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 the Oncotype DX test has been shown to have independent value beyond currently used measures for determining colon cancer recurrence risk. For people recently diagnosed with stage II and stage III 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
Stage II & III Colon Cancer - Commonly Used Adjuvant Therapies
For stage II and III colon cancer, the most commonly used adjuvant therapies involve fluoropyrimidines (e.g. 5-Fluorouracil, capecitabine) given alone or in combination with oxaliplatin. Oxaliplatin is known to produce significant toxicities, including the potential for long-term sensory nerve damage 9, 10. As such, methods to identify the likelihood of benefit of adding oxaliplatin to chemotherapy regimens are needed to guide the optimal use of this drug. Genomic Health has completed validation of the Oncotype DX colon cancer test for treatment planning in patients with stage II and stage III colon cancer. The Oncotype DX Colon Cancer Assay is now commercially available for those with stage II and stage III disease.
Learn more about additional Genomic Health products in development:
- Mattson Jack, CancerMPact November 2010 (2011 incidence).
- Company figure adapted from MattsonJack, CancerMpact, November 2010 (2011 incidence).
- Cancer Facts and Figures. Atlanta, GA: American Cancer Society; 2010.
- Benson AB 3rd, Schrag D, Somerfield MR, et al. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol 22:3408-3419, 2004.
- NCCN Clinical Practice Guidelines for Oncology: Colon Cancer v3.2012: National Comprehensive Cancer Network; 2012
- Gray RG, Quirke P, and Handley K. Validation study of a quantitative multi-gene RT-PCR assay for assessment of recurrence risk in stage II colon cancer patients. J Clin Oncol. 2011; 29: 4611-9.
- Venook AP, Niedzwiecki D, Lopatin M, et al. Validation of a 12-gene colon cancer recurrence score (RS) in patients (pts) with stage II colon cancer (CC) from CALGB 9581. Poster presented at the ASCO Annual Meeting; 2011; Chicago, IL.
- O'Connell MJ, Lee M, Lopatin M, et al. Validation of the 12-gene colon cancer Recurrence Score result in NSABP C-07 as a predictor of recurrence in stage II and II colon cancer patients treated with 5FU/LV (5FU) and 5FU/LV + oxaliplatin (5FU+Ox). Poster presented at the ASCO Annual Meeting; 2012; Chicago, IL.
- André T, Boni C, Navarro M, et al. Improved Overall Survival With Oxaliplatin, Fluorouracil, and Leucovorin As Adjuvant Treatment in Stage II or III Colon Cancer in the MOSAIC Trial. J Clin Oncol 2009; 27 (19): 3109-3116.
- Land SR, Kopec JA, Cecchini RS, et al. Neurotoxicity From Oxaliplatin Combined With Weekly Bolus Fluorouracil and Leucovorin As Surgical Adjuvant Chemotherapy for Stage II and III Colon Cancer: NSABP C-07. J Clin Oncol 2007; 25 (16): 2205-2211