HAVE YOU BEEN NEWLY DIAGNOSED with DCIS?

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1 HAVE YOU BEEN NEWLY DIAGNOSED with DCIS? Jen D. Mother and volunteer. Diagnosed with DCIS breast cancer in An educational guide prepared by Genomic Health This guide is designed to educate women newly diagnosed with DCIS about the Oncotype DX Test, a diagnostic test that may help you and your doctor make a more informed treatment decision based on your tumor s biology.

2 I had my Surgical Oncologist, my Medical Oncologist, and my Radiation Oncologist in the room with me discussing my treatment options. There was only one way to start: The Oncotype DX Test for DCIS, which would determine what my individual risk of recurrence would be for DCIS. Carol F., nurse and grandmother. Diagnosed with DCIS breast cancer in

3 Have you recently been diagnosed with a non-invasive form of breast cancer called DCIS? Are you struggling to understand what your treatment options are? DCIS is one of the most commonly diagnosed breast conditions. It is considered to be an early, non-invasive form of breast cancer. 1 Ductal carcinoma means the tumor is within the milk ducts In situ means it is in its original place and has not spread beyond the ducts It is overwhelming to get the diagnosis. Even after therapy, women with DCIS are at increased risk for the cancer coming back in the same breast (called local recurrence), either as DCIS or as invasive breast cancer. Planning Your Treatment After a diagnosis of DCIS, the first step is usually surgery to remove the DCIS tumor. Following surgery, the next step is to determine how likely your cancer is to return, which may help you and your doctor make decisions about future treatment options. This education piece is not designed to provide individual advice in connection with your diagnosis or treatment plan. Such matters should be discussed with your healthcare provider. 53

4 Gathering Information to Help Make the Right Treatment Decision for You There are several treatments for DCIS after surgery, so it is important to gather as much information as possible to decide on a treatment plan that is right for you. Your doctor may consider many factors in planning your treatment, including: your medical history your age size and grade of your DCIS tumor whether your tumor cells have estrogen receptors surgical procedures, including margin width the results of your Oncotype DX Test your treatment preferences Because every woman s breast cancer is unique, you and your doctor will need to understand the underlying biology of your tumor to further individualize your treatment plan. What Is the Oncotype DX Test? The Oncotype DX Test for DCIS is a genomic diagnostic breast cancer test that measures a group of cancer genes in your DCIS tumor. Studies show that the results from the Oncotype DX Test strongly predict whether cancer may come back in the same breast. 2 4

5 The Oncotype DX Test was a really key piece of evidence for me. My DCIS Score result helped me assess the risks and confirmed my treatment decision. 5

6 46 I had always thought of DCIS as cancerlite but it s really not. The uncertainty was incredibly unsettling and that was why the Oncotype DX Test was so helpful for me. It helped to make concrete something that no one could see.

7 Why Should I Consider the Oncotype DX Test? This is a unique test that provides information specific to your tumor, not available from traditional factors. Since the Oncotype DX Test provides individualized information, it enables the treatment plan to be tailored specifically for you. It gives you and your doctor a better understanding of how your DCIS tumor behaves. In the past, most patients with DCIS have received aggressive treatment. This meant some women with DCIS may have received therapy that provided limited benefit. Now, the Oncotype DX Test for DCIS can help identify low-risk and high-risk DCIS. With this information, the treatment plan can be tailored specifically for you. Speak with your healthcare team to understand how the Oncotype DX Test results may impact your treatment plan. Is the Oncotype DX Test Right for Me? The test may be right for you if you are planning treatment after surgery, and: are newly diagnosed with DCIS breast cancer have had breast-conserving surgery (lumpectomy) and not total mastectomy 57

8 How Will the Oncotype DX Test Help Me and My Doctor? The test will tell you and your doctor the chances of your tumor coming back, which may help guide treatment decisions. Your doctor will receive a report with the results of the Oncotype DX Test. The report contains your DCIS Score result, a number between 0 and 100. Women with lower DCIS Score results have a lower risk that their cancer may return and may be treated more conservatively Women with higher DCIS Score results have a greater chance that their breast cancer may return and may benefit from additional therapies How Is the Oncotype DX Test Performed? The test is performed on a small amount of your DCIS tumor tissue that was removed during your original surgery (lumpectomy or core biopsy). This tissue is routinely saved and stored at the hospital where you had your surgery. You will NOT have to go through any additional surgery or procedure to get the Oncotype DX Test. When your doctor orders the Oncotype DX Test, the hospital will send a sample of your tissue to Genomic Health, the laboratory that performs the Oncotype DX Test. 48

9 One of the most important resources was learning that I had a higher risk of recurrence (because my DCIS score was high), so I chose radiation as part of my treatment plan. Most important were my physicians (who were aware of the importance of the Oncotype DX Test), my friends, my peers, and most of all, my family. 59

10 410 The most important things I took away from my Oncotype DX experience were knowledge and the empowerment to make my treatment decision.

11 How Has the Oncotype DX Test Been Studied? The Oncotype DX Test for DCIS has been studied in a trial with over 300 women with DCIS, demonstrating accuracy and consistency. The company s first test, Oncotype DX Test for invasive breast cancer, has been studied in multiple trials involving more than 4000 women. 3-9 In addition to DCIS, Genomic Health (the company that developed the Oncotype DX Test) offers tests for invasive breast cancer and colon cancer. To date, the Oncotype DX Test (for both invasive breast cancer and colon cancer) has been ordered by over 10,000 doctors in over 65 countries for more than 320,000 patients. 10 To learn more about these trials, please visit When Should the Oncotype DX Test Be Done? It is important that your doctor request the Oncotype DX Test before you start any treatment, since the test is intended to help determine how likely your cancer is to return, which may guide treatment decisions. Surgery to remove tumor Doctor orders the Oncotype DX Test Hospital sends sample of tumor to the Genomic Health laboratory The Genomic Health laboratory analyzes the 21 genes Doctor receives the Recurrence Score result Doctor and patient discuss the results and personalize treatment 11 5

12 How Do I Get the Oncotype DX Test? The test can only be ordered by a licensed healthcare professional, such as your doctor. You may wish to share this brochure with your doctor and ask if the Oncotype DX Test may be of benefit to you. How Long Will It Take to Get the Results of the Oncotype DX Test? Most results from the Oncotype DX Test are available within 7 to 10 days from the date the tumor sample is received by the Genomic Health laboratory. The results are sent to your doctor so that he or she can discuss the results with you and answer your questions. Understanding Your DCIS Score Result The Oncotype DX Test produces a unique DCIS Score result, a number between 0 and 100. Women with lower DCIS Score results have a lower risk that their cancer may come back in the same breast (local recurrence), either as DCIS or as an invasive tumor. It does not mean that there is no chance of the cancer returning 412

13 Having the Oncotype DX Test gave me peace of mind that I was making the right decision for me. 13 5

14 Women with higher DCIS Score results have a greater risk their cancer may come back in the same breast. It does not mean that cancer will definitely return, but it means that you may want to consider additional therapies The Oncotype DX Test will also provide information about the activity levels of hormone receptors in your tumor, which may help further guide your treatment. Is the Oncotype DX Test Covered by Insurance? Once you and your doctor agree the Oncotype DX Test is right for you, you will likely want to find out if it is covered by your insurance. Coverage varies by insurance plan for all medical services and benefits. Genomic Health, the company that developed and performs the Oncotype DX Test, has a program called GAP (Genomic Access Program) to help you through the process. GAP can help you find out if the test is covered and help process the claim once the test is complete. GAP can also help with the appeal process if your claim is denied. GAP also offers financial assistance for all patients who qualify (including uninsured and underinsured patients). 414

15 Please note that you may be financially responsible for some or all costs associated with the Oncotype DX Test. For specific insurance and financialaid questions, please contact Genomic Health Customer Service at 866-ONCOTYPE ( ) and we will be happy to assist you. For additional resources and information, please visit or 155

16 List of Terms Assay: A laboratory test. Cancer: A term for diseases in which abnormal cells divide without control or order. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymph nodes to other parts of the body. Cell: The smallest unit of a tissue that makes up any living thing. Cells have a very specialized structure and function. Chemotherapy: Treatment with drugs to destroy or slow the growth of cancer cells. Clinical Trial: A research study where patients help scientists evaluate ways to prevent, detect, diagnose, or treat diseases. Ductal Carcinoma in situ (DCIS): An early or non-invasive form of breast cancer that is confined to the milk ducts within the breast, and is considered Stage 0 disease. Early-Stage Breast Cancer: Breast cancer is categorized by stage based on the size of the tumor and whether the cancer has spread. Stages I, IIA, IIB, and IIIA are considered early stage and refer to cancers that may have spread to nearby lymph nodes but not to distant parts of the body. 416

17 Gene: The basic unit of heredity found in most cells of the body. Genomics: The study of complex sets of genes, their expression (level of activity), and their effects on biology. Hormonal Therapy: The use of specific drugs, such as tamoxifen or aromatase inhibitors, to reduce or regulate the production or effects of hormones in the body. Lumpectomy: A surgical procedure that removes a localized mass of tissue, including the breast cancer tumor and a small amount of tissue surrounding the tumor. Margin: Healthy normal tissue that surrounds the edge of the tumor tissue that is removed during surgery. Negative or clear margin means the cancer was entirely removed; positive margin means some cancer cells still remain after surgery. Mastectomy: A surgical procedure to remove all or part of the breast. Newly Diagnosed: A term used to describe breast cancer that has recently been identified in a patient. 17 5

18 Oncotype DX Test: The Oncotype DX Tests are unique diagnostic tests that look at the genomic profile of a tumor. Radiation: The use of radiation to destroy cancer cells. Radiation therapy may be used before or after surgery, and is sometimes used in combination with chemotherapy. Radiation is used for local control of the cancer at the site of the tumor. Tumor: Tissue growth in which 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. Tumor Size: How big the tumor is, usually reported in metric units (millimeters or centimeters). 418

19 The Oncotype DX Test solidified the direction I wanted to go. I think I would have been considerably more uncertain about my final decision without knowing the DCIS Score Result. 195

20 To learn more about the Oncotype DX Test, visit and talk to your healthcare team. For insurance, financial aid, or other questions about the Oncotype DX Test, please call US (English) 866-ONCOTYPE ( ), US (Spanish) , and international For more information about this and other Oncotype DX tests, please visit or The people shown in this booklet used the Oncotype DX Breast Cancer Test in making their treatment decisions with their physicians. References: 1. Polyak et al. J Natl Cancer Inst Monogr Solin et al. SABCS Abstract S Dowsett et al. J Clin Oncol Albain et al. Lancet Oncol Goldstein et al. J Clin Oncol Paik et al. J Clin Oncol Habel et al. Breast Cancer Res Paik et al. ASCO Abstract Paik et al. N Engl J Med Data on file. Genomic Health, Inc. Redwood City, CA. Genomic Health, Oncotype DX, DCIS Score, and Uncover the Unexpected are trademarks of Genomic Health, Inc Genomic Health, Inc. All rights reserved. GHI10176_1112 oncotypedx.com