Questions for your Breast Surgeon and Medical Oncologist:
- Do I qualify for an Oncotype DX genomic test?
- If so, will you order genomic testing for me?
- Would you order a genomic test before I see a medical oncologist?
- Are there any other genomic tests that apply to me?
What is a genomic assay?
These sophisticated tests are performed on a small sample of cancer tissue in appropriate patients with early-stage breast cancer. Genomic tests are usually ordered after surgery when the pathology report is finalized. It measures unique aspects of the tumor to determine if a patient will benefit from chemotherapy in addition to hormonal therapy. Such “genomic assays” developed over the last decade are a dramatic advance in breast cancer care. The Oncotype DX assay (here) by Genomic Health Inc. is the most utilized genomic assay of those available in the United States.
While their names sound similar, breast cancer genomic testing and genetic testing are very different. Genetic testing determines if you inherited a broken gene that may cause you to develop certain types of cancers in your lifetime. Genomic testing is a deeper look into the genetic changes of your individual cancer cells to determine the best cancer therapy. View our video lesson on “BRCA Genetic Testing” (here) to learn more about genetic testing for breast cancer.
Who should consider a genomic test?
Patients who have small “Estrogen receptor positive” (ER+) and “HER2 receptor negative” (HER2-) tumors and no evidence of cancer in their lymph nodes may benefit from an Oncotype DX assay. The purpose of this test is to better identify people who do and do not benefit from chemotherapy. The decision to undergo chemotherapy is a complicated one. Your medical oncologist will examine multiple factors to help determine if you will benefit from chemotherapy. The NCCN Guidelines, listed in the website links below, outline in much greater detail recommendations for the use of genomic tests. An Oncotype DX test can be instrumental in this decision for many patients.
You may qualify for an Oncotype DX test if…
- You have early-stage cancer (Stage I or II)
- Your tumor is Estrogen receptor positive (ER+)
- Your tumor is Her2 receptor negative (HER2-)
- No cancer was found in your lymph nodes
- You are willing to consider having chemotherapy
- You are healthy enough to undergo chemotherapy
Why would I ask my surgeon to order this after surgery?
You will return to see your breast surgeon for a “post-operative visit” about a week after your surgery to discuss your final pathology results. If you do qualify for an Oncotype DX test, ask your surgeon to order the test before your initial medical oncology consultation. It takes about two weeks to get the results. Therefore, if you make your first medical oncology consultation appointment about three weeks after the test is ordered, you will have all the information needed to make a definitive decision about chemotherapy and hormonal therapy. More and more breast surgeons are ordering this test to speed up treatment decisions for their patients.
How is chemotherapy tailored to patients?
Genomic breast cancer tests are a leap forward in our ability to “look inside” breast cancer cells. Sophisticated breast cancer care is based upon the principle of providing maximal benefit from the least toxic therapy. Newly diagnosed breast cancer patients deserve the best information available to decide whether they need chemotherapy. Take our video lesson on “Will I Need Chemotherapy?“ (here) to understand the general concepts. Genomics is a promising and rapidly developing field.
These genomic assays are now incorporated into major clinical practice guidelines. Oncotype DX results are now incorporated into NCCN Breast Cancer Clinical Practice Guidelines, ASCO guidelines, and the 8th Edition of the AJCC Breast Cancer Staging Manual. Genomic information adds to the tools a medical oncologist can use to advise patients, at their initial consultation, about chemotherapy and hormonal therapy. Patients can then enter into these complicated discussions better educated about their treatment options with knowledge of genomic testing. Unfortunately, these sophisticated tests are not embraced by some breast cancer specialists. Inquire if you qualify for a genomic Oncotype DX assay or another similar test. Be your own advocate.
Other Genomic Tests:
Multiple genomic tests are currently available. Deciding who may benefit from these expensive tests can be difficult in some situations. You benefit when your breast surgeon, medical oncologist, and radiation oncologist work together. We recommend that newly diagnosed patients be evaluated by breast cancer specialists who are well-versed in the genomics of breast cancer. Below, we list the most established breast cancer genomic tests currently available.
Oncotype DX Breast DCIS Test
This assay of DCIS or “precancerous” breast cells may help identify some women who may not benefit from radiation therapy after a lumpectomy. Genomic Health Inc. is a leading personalized medicine company. More information is about this test is located (here).
This genomic test is used for Stage I and II breast cancers to determine prognosis and survival. This test is now included in national guidelines for some with hormone-sensitive breast cancers that are found to have a small amount of cancer in a few lymph nodes. It is also a genomic test for some without “node positive” breast cancer. Agendia is a leader in personalized and molecular cancer diagnostics. More information about MammaPrint is located (here).
EndoPredict is a 2nd generation genomic breast cancer recurrence test to assess for 10-year risk of cancer recurrence. This test also accounts for tumor size in helping determine if chemotherapy may be needed in early-stage, favorable breast cancers. Myriad Genetics is a global leader in genetic testing and personalized medicine. More information about Endopredict is located (here).
Breast Cancer Index (BCI)
This test is designed for women with favorable, early-stage breast cancer who have been on hormonal therapy for 4 to 5 years. It can help determine if someone will benefit (or can avoid) five additional years of hormonal therapy, such as tamoxifen or an aromatase inhibitor. This test is not yet approved by the FDA. Medicare and some insurance companies may cover the cost. Biotheranostics is a molecular diagnostics company. More information about BCI is located (here).
Are genomic tests covered by insurance?
Most genomic tests are covered by Medicare and commercial insurance companies. Not everyone needs a genomic test to decide upon the best cancer treatment plan. Ask your breast cancer specialists if a genomic test would be helpful in your comprehensive cancer treatment plan.
Take Home Message:
Make sure to ask both your breast surgeon and medical oncologist if a genomic assay might play a role in your treatment decisions. For appropriate patients, these tests should be considered only one piece of the many “pieces of the puzzle” in deciding treatment decisions about chemotherapy and hormonal therapy.
This link to their “Oncotype DX” page (here) outlines this genomic test in more detail. This non-profit organization provides excellent patient resources about breast cancer.
This page (here) “Oncotype DX and MammaPrint” offers a brief comparison of the Oncotype DX and MammaPrint genomic assays. This site is created for patients by the American Society of Breast Surgeons.
This page (here) on “Tumor Profiling – Personalizing Treatment for Breast Cancer” is an excellent overview of genomic testing for invasive breast cancer. The Susan G. Komen organization is a leading advocacy group dedicated to assisting patients, funding research, and ensuring quality breast cancer care.
This simple “Genetics vs Genomics” brochure (here) simply outlines the differences between these two very important terms. Genomic Health Inc. is a leading personalized medicine company.
This website (here) provides more information about the Oncotype DX assay from its manufacturer, Genomic Health Inc. Genomic Health Inc. is a leading personalized medicine company.
This video (here) outlines the MammaPrint Assay in more detail, from its manufacturer, Agendia. Agendia is a leading molecular diagnostics company.
This page (here) “What is Endopredict?” provides an overview of this breast cancer genomic test. Myriad Genetics is a global leader in genetic testing and personalized medicine.
More Detailed References:
If you want to get deep into the details, this free 200-page PDF document (here) has guidelines to help clinicians to make treatment recommendations about nearly all aspects of breast cancer. You can easily register (here) as a non-professional to get access and more information about breast cancer. The National Comprehensive Cancer Network is the leading organization in developing clinical guidelines.