The big question is how to figure out if you are:
The Oncotype DX test may offer you and your doctor another piece of information you can use to predict your risk of cancer recurrence, so that you can make the best treatment decisions.
Each woman's situation is different. For many women with hormone-receptor-positive, node-negative breast cancer, doctors can make solid treatment recommendations based on a combination of reliable cancer features.
For example, if you've been diagnosed with a cancer that's smaller than one centimeter, low grade, HER2-negative, with no lymphatic or vascular invasion, then you have a low-risk, favorable situation, and chemotherapy is unlikely to give you any more benefits than hormonal therapy alone. But if the cancer is medium-sized or bigger, high grade, and HER2-positive, then chemotherapy will have a very important role, and this new test is unlikely to change that reality. If you're in between those two very different situations, your doctor might recommend the Oncotype DX test to help figure out the best treatment plan for you.
It's important to keep in mind that the Oncotype DX test only helps determine the role of chemotherapy based on your risk of recurrence. It does not tell you if you should have radiation therapy, Herceptin (chemical name: trastuzumab) treatment, or hormonal therapy. It also doesn't tell you what kind of chemotherapy to have.
Clinical trial announced: Genomic Health announced a new national clinical trial called Trial Assigning Individualized Options for Treatment (TAILORx), scheduled to begin enrolling participants in February 2006. The trial will be led by the Eastern Cooperative Oncology Group (ECOG) and funded by the National Cancer Institute. It will include more than 4,000 women with estrogen-receptor-positive, node-negative breast cancer.
Oncotype DX recurrence scores between 11 and 25 fall across low and intermediate risk categories. The researchers want to know if women with recurrence scores in this 11 to 25 range would benefit from chemotherapy in addition to hormonal therapy. The researchers also want to know if a specific recurrence score can be used as a cutoff point to recommend or not recommend chemotherapy.
Women who enroll in the TAILORx trial will get an Oncotype DX test done after surgery. Then, based on the recurrence score, the women will be assigned to a treatment regimen:
Genomic Health will help women who enroll in the trial get reimbursement from their insurance companies for the cost of the Oncotype DX test. Women without insurance will not have to pay for the test.
Stay tuned to breastcancer.org for more information on this important trial and how cancer genetics research can help you make more informed decisions about your treatment.
We are grateful to our Professional Advisory Board member Dr. Ruth Oratz for her contribution to this work.
The January 2006 Research News section was made possible by an unrestricted educational grant from Genentech BioOncology.
Reviewed study: "Oncotype DX Test Helps Make Chemo Decisions for Women with ER-Positive Cancer" by S. Shak and others, San Antonio Breast Cancer Symposium, December 9, 2005, Special Advocacy Group Presentation
Is this for me? If you've been diagnosed with node-negative, estrogen-receptor-positive breast cancer and are trying to figure out if you need chemotherapy, you might want to read this article.
Background: The Oncotype DX test looks at many different genes in a breast cancer. Genes control the behavior and activities of all cells, including cancer cells. Remember the expression, "where there's smoke, there's fire"? When cells are behaving abnormally, a high level of certain genes is usually present. By measuring the levels of specific genes, the Oncotype DX test calculates a recurrence score. The higher the recurrence score, the more likely the cancer is to come back. In combination with other factors, such as age, cancer size, levels of hormone receptor protein, and cancer grade, this recurrence score can help predict the risk of cancer coming back in women with node-negative, estrogen-receptor-positive breast cancer.
A woman whose risk of recurrence is high needs to seriously consider having chemotherapy, in addition to hormonal therapy after surgery with or without radiation.
Many health insurance companies have not yet decided if they will cover the cost of the Oncotype DX test. It is relatively new and expensive—about $3,500. If you and your doctor decide to use the test, your doctor's office may be able to help you talk to your insurance company. The company that makes the Oncotype DX test, Genomic Health, Inc., provides help too. Their toll-free number is 866-ONCOTYPE (866-662-6897). If you have a low recurrence score and as a result you and your doctor decide you don't need to have chemotherapy, you and the insurance company can save much more than the cost of the test.
At the 2005 San Antonio Breast Cancer Symposium, Genomic Health released early results from a study showing how the Oncotype DX test can be used to make decisions about chemotherapy after surgery for women with node-negative, estrogen-receptor-positive breast cancer. Genomic Health also announced a new clinical trial that will further study the Oncotype DX test.
Study design: In this small study of 67 women and 1 man with node-negative, hormone-receptor-positive breast cancer, participants were classified as having low, intermediate, or high risk for recurrence based on their Oncotype DX recurrence score:
Doctors were asked to make two treatment recommendations for the participants:
Results: Before knowing the recurrence scores, the doctors recommended that:
After the doctors were told the recurrence scores for each participant, they recommended that:
Although the total numbers in each recommended treatment group look similar, it turns out that the doctors' recommendations changed for 14 of the participants because of the recurrence score:
Conclusions: This study shows that based on their Oncotype DX recurrence score, seven women were able to avoid chemotherapy. Seven other women found out that their cancer was more serious than anticipated, and so had chemotherapy in addition to hormonal therapy.
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