? Have you recently been diagnosed with stage II or stage III colon cancer? Have you discussed your risk of recurrence with your physician? Is chemotherapy being considered as part of your treatment plan? This guide is designed to educate patients newly diagnosed with either stage II or III colon cancer, about the Oncotype DX Colon Cancer Test, a genomic test that can help you and your doctor make a more informed individualized treatment decision.
Have you recently been diagnosed with stage II or stage III colon cancer? Based on the risk factors you and your doctor have discussed, are you seeking more information to make treatment choices? You may be interested to know that the Oncotype DX Colon Cancer Test is a first-of-its-kind diagnostic test that helps identify the risk of your colon cancer returning following surgery. It offers information about the biological activity of an individual s tumor that traditional technologies do not capture. Armed with information provided by the Oncotype DX Colon Cancer Test, you and your doctor can make a more informed, more individualized treatment decision. The need for treatment planning After you have been diagnosed with colon cancer, you and your doctor work together to plan an appropriate treatment following surgery. The goal is to keep the colon cancer from coming back. One key step in treatment planning is to understand the likelihood that your colon cancer will return. Risk of recurrence is an important consideration in deciding whether a patient with stage II colon cancer should or should not get chemotherapy after surgery. For a patient with stage III colon cancer, the risk of recurrence can help determine which chemotherapy may be most appropriate. The Oncotype DX Colon Cancer Test provides a way of estimating your risk of recurrence in either stage II or stage III colon cancer, and enables you to make a more informed decision about your treatment. 2
introduction Gathering information to guide the treatment decision While it can be overwhelming to receive a diagnosis of colon cancer, it is important to gather as much information as possible to determine a treatment plan that is right for you. Because every patient s colon cancer is unique, your doctor will design a treatment plan based on the specific characteristics of your tumor. To help your doctor better understand your cancer, many factors may be assessed. These factors include: Whether there is lymph-node involvement The grade of the tumor The T-stage MMR The presence or absence of bowel perforation or obstruction Whether there is lymphatic or vascular invasion The Oncotype DX Colon Cancer Test provides individualized information about your tumor s characteristics that is not available from these other factors. The test measures the activity of 12 different genes that, when analyzed together, provide quantitative information about the likelihood of your cancer recurring. Right now, learning as much as you can about your specific colon cancer tumor can help you and your healthcare team develop a more informed treatment plan, individualized to treat your tumor s specific characteristics. 3
What is the Oncotype DX Colon Cancer Test? The Oncotype DX Colon Cancer Test is a unique diagnostic test that looks at the activity of 12 different genes in an individual s colon tumor tissue. Together, the information about those genes is used to assess the likelihood of your colon cancer returning in the future (risk of recurrence). What are the benefits of getting the Oncotype DX Colon Cancer Test? The Oncotype DX Colon Cancer Test gives you and your doctor a better understanding of how likely it is that your cancer will return. For Stage II, this important information may help your doctor decide whether to recommend chemotherapy following surgery; for stage III, this may help your doctor decide which chemotherapy to recommend following surgery. Speak with your healthcare team to understand how the Oncotype DX Colon Cancer Test results may impact your treatment planning Is the Oncotype DX Colon Cancer Test right for me? The Oncotype DX Colon Cancer Test is appropriate for men and women with newly diagnosed stage II or stage III colon cancer. 4
frequently asked questions What will I learn from the Oncotype DX Colon Cancer Test? Your doctor will receive a report with the results of your Oncotype DX Colon Cancer Test. The report contains your Recurrence Score result, which is a number between 0 and 100. It also provides a specific estimate of your risk of colon cancer recurrence. A Recurrence Score result, along with other information, can help you and your physician make a more informed, individualized treatment decision. Individuals with a lower Recurrence Score result have a lower risk of their colon cancer returning. Individuals with a higher Recurrence Score result have a higher risk of their colon cancer returning. It is important to understand that having a lower Recurrence Score result does not mean that there is no chance that your colon cancer will return. Likewise, having a higher Recurrence Score result does not mean that your colon cancer will definitely return. The report may also provide your MMR status which may help you and your doctor in making treatment decisions. Studies have shown that stage II colon cancer patients with MMR-D tumors have a lower risk of recurrence compared to patients with MMR-P tumors. Similarly, the approximately 10% of stage III colon cancer patients with MMR-D tumors have lower recurrence risk than stage III patients with MMR-P tumors. 5
How is the Oncotype DX Colon Cancer Test performed? The Oncotype DX Colon Cancer Test is performed on tumor tissue that was removed during your original surgery. This tissue is routinely saved and stored at the hospital where you had your surgery. When your doctor orders the Oncotype DX Colon Cancer Test, the hospital will send a sample of your tissue to the Genomic Health laboratory that performs the Oncotype DX Colon Cancer Test. You will NOT have to go through another surgery or procedure to get the Oncotype DX Colon Cancer Test. How was the Oncotype DX Colon Cancer Test validated? The Oncotype DX Colon Cancer Test was validated (proven to work) in several clinical trials. For stage II colon cancer, the Oncotype DX Colon Cancer Test was validated in three independent studies (QUASAR 1, CALGB 9581 2, NSABP C-07 3 ); For stage III colon cancer, the Oncotype DX Colon Cancer Test was validated in the NSABP C-07 trial. The results showed that the Recurrence Score result directly correlates with the risk of recurrence in people with colon cancer. Furthermore, these results demonstrated that the higher the Recurrence Score result, the higher the risk of recurrence, and the lower the Recurrence Score result, the lower the risk of recurrence 1. To learn more about these clinical trials, please visit www.oncotypedx.com. 6
frequently asked questions When should the Oncotype DX Colon Cancer Test be done? It is important for your doctor to request the Oncotype DX Colon Cancer Test after your surgery and before you start any chemotherapy. For patients diagnosed with Stage II colon cancer: The Oncotype DX Colon Cancer Test can help you and your doctor determine whether chemotherapy should be part of your treatment plan. Stage III colon cancer: The Oncotype DX Colon Cancer Test can help you and your doctor determine which chemotherapy may be best for you. How long will it take to get the results of the Oncotype DX Colon Cancer Test? It typically takes 7 to 10 days from the date laboratory processing begins for the results of the Oncotype DX Colon Cancer Test to be available. The results are sent to your doctor so that he or she can discuss them with you and answer your questions. How do I get the Oncotype DX Colon Cancer Test? Only a licensed healthcare professional, such as your doctor, may order the Oncotype DX Colon Cancer Test. You may wish to share this brochure with your doctor and ask if the Oncotype DX Colon Cancer Test may be of benefit to you. 7
What does MMR tell me? Knowing your MMR status may help you and your doctor in making treatment decisions. Studies have shown that in both stage II and stage III colon cancer, patients with MMR-D tumors have a lower risk of recurrence compared to patients with MMR-P tumors. 1 3 Is the Oncotype DX Colon Cancer Test covered by insurance? For assistance in researching your insurance benefits, you can contact the Genomic Health Genomic Access Program (GAP). You can contact GAP directly, or your doctor s office can help by working with GAP to determine eligibility based on your insurance plan. GAP also provides services such as referrals to financial assistance programs, if you qualify. For information on reimbursement for the Oncotype DX Colon Cancer Test, or for any other questions, call 866-ONCOTYPE (866-662-6897). GAP Services: Financial assistance for all patients who qualify (including uninsured and underinsured patients) For patients with insurance, GAP can determine up front whether your plan covers the test Prior authorization from your insurance company (if required) Processing of your claim when the test is complete (as required) Assistance throughout the appeals process if your claim is denied (at your or your doctor s request) 8
frequently asked questions Are there any online resources for colon cancer patients? My Colon Cancer Coach at www.mycoloncancercoach.org is the first patient-focused, interactive online resource where newly diagnosed colon cancer patients can learn more about their disease. The site includes a questionnaire that takes less than 10 minutes to complete and provides patients with information unique to their diagnosis, including relevant treatment options to discuss with your physician. For additional resources and information, please visit www.oncotypedx.com. For an interactive online resource for newly diagnosed colon cancer patients, please visit www.mycoloncancercoach.org. 9
Bowel obstruction: When a section of intestine becomes blocked preventing the contents from flowing normally. Bowel perforation: When a hole develops through the entire wall of the intestines. CALGB 9581: The Cancer and Leukemia Group B is a national clinical research group sponsored by the National Cancer Institute to conduct clinical trials to develop treatments for cancer. Cancer: A condition in which abnormal cells divide without control or fail to die as part of a normal cell s life cycle. Cancer cells can also invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body. Chemotherapy: Treatment with drugs that destroy cancer cells. Chemotherapy may be given in addition to surgery. Clinical trial: Research study to evaluate the effectiveness and safety of medications, devices, procedures, and testing technologies. Diagnosis: Identification of a condition, such as colon cancer, by its signs and symptoms and the results of laboratory tests or other examinations. Gene expression: The level of activity of a gene or group of genes. Lymph-node involvement: When cancer cells are found in lymph nodes and/or blood vessels. Lymphatic/vascular invasion: When cancer cells are observed in lymphatic and/or blood vessels (based on the pathologist s assessment of the tumor specimen.) MMR (Mis-Match Repair): A system within the cell for correcting errors in DNA that works by detecting and replacing bases in the DNA that are wrongly paired (mismatched bases). 10
list of terms Approximately 15% of stage II colon cancers are caused by a defect in the DNA MMR pathway. MMR-D = MMR-deficient MMR-P = MMR-proficient Newly diagnosed: A term used to describe colon cancer that has recently been identified in a patient. NSABP C-07: The National Surgical Adjuvant Breast and Bowel Project sponsors a series of clinical studies; the C-07 study validated the use of the Oncotype DX Colon Cancer Test Recurrence Score result in people with stage II and stage III colon cancer. The Oncotype DX Colon Cancer Assay: A unique diagnostic test that looks at the genomic profile of a surgically removed colon tumor to predict the likelihood that stage II or stage III colon cancer will return, or recur. QUASAR: Quick And Simple And Reliable is a clinical study of people with stage II colon cancer that validated the significant roles of the Oncotype DX Colon Cancer Recurrence Score result, MMR status and T-stage in the assessment of risk in patients with stage II colon cancer. Recurrence: The return of cancer after treatment. Resection: A surgical procedure to remove primary colon cancer. Stage II colon cancer: Cancer that has spread into the outer layers of the colon and that may have spread to nearby tissue but that has not spread to the lymph nodes. Also called Dukes B colon cancer. Stage III colon cancer: Cancer that has spread beyond the outer layers of the colon to nearby lymph nodes, but not to other tissues or organs. 11
T-stage (Tumor-stage): Refers to the depth of penetration of the tumor at time of surgery. In colon cancer, tumor size is not as critical as depth of invasion and nodal status in determining prognosis. Tumor: Tissue growth where the cells that make up the tissue have multiplied uncontrollably. A tumor can be benign (noncancerous) or malignant (cancerous). Tumor grade: Characterization of a tumor based on how similar the cancer cells are to normal cells. To learn more about the Oncotype DX Colon Cancer Test, visit www.oncotypedx.com and talk to your healthcare team. For insurance and financial-aid questions or other questions about the Oncotype DX Colon Cancer Test, within the United States call 866-ONCOTYPE (866-662-6897); patients outside the United States should call +1-650-569-2080. For more information about Genomic Health, including areas of research, please visit www.genomichealth.com or www.oncotypedx.com. For an interactive online resource for newly diagnosed colon cancer patients, please visit www.mycoloncancercoach.org. Reference: 1. Kerr D, et al. A quantitative multigene RT-PCR assay for prediction of recurrence in stage II colon cancer: selection of the genes in four large studies and results of the independent, prospectively designed QUASAR validation study. J Clin Oncol. 2009;27(15S)(suppl). Abstract 4000. 2. Venook A, Niedzwiecki D, Lopatin M, et al. Cancer and Leukemia Group B. Validation of a 12-gene colon cancer recurrence score (RS) in patients (pts) with stage II colon cancer (CC) from CALGB 9581. Presented at: American Society of Clinical Oncology; June 2011; Chicago, IL. 3. O Connell MJ, Yothers G, Lee M, et al. Validation of the 12-gene colon cancer Recurrence Score in NSABP C-07 as a predictor of recurrence in stage II and III colon cancer patients treated with 5FU/LV and 5FU/LV + oxaliplatin. 2012 American Society of Clinical Oncology, Abstract 3512. 4. Gray RG, Quirke P, Handley K, et al. Validation study of a quantitative multigene reverse transcriptase polymerase chain reaction assay for assessment of recurrence risk in patients with stage II colon cancer. J Clin Oncol. 2011; doi:10.1200/jco.2010.32.8732. Genomic Health, Oncotype DX, Recurrence Score and Confidence. Confirmed are trademarks of Genomic Health, Inc. 2012 Genomic Health, Inc. All rights reserved. GHI30009_0612