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How Accurate Is Oncotype Dx Test For Breast Cancer

Higher Score Means A Higher Risk

When To Get Oncotype DX Breast Cancer Test

The test looks at 21 different genes within the cells of a tumor sample. Certain patterns suggest a more aggressive cancer that is more likely to come back after treatment. The test results show a score between 0 and 100.

If you have early-stage invasive breast cancer and are over 50 years old, the scoring is as follows:

  • A score between 0 and 25 means you have a low risk of the cancer returning if you get hormone treatment. With this score you probably will not benefit from receiving chemotherapy.
  • A score between 26 and 100 means you have a higher risk that the disease might come back. Both hormone treatment and chemotherapy are likely to be recommended.

If you have early stage invasive breast cancer and are age 50 or younger, the scoring is as follows:

If youâve been diagnosed with DCIS, the results are called a DCIS score, and the numbers are different:

  • A score of 38 or lower means you have a low risk of cancer returning, and the risks of radiation treatments outweigh any benefits for you.
  • A score between 39-54 means youâre at medium risk and itâs unclear if radiation will help.
  • A score greater than 54 means youâre at high risk of the cancer coming back. Youâll likely benefit most from radiation therapy.

Which Blood Tests Are Used To Diagnose Cancer How Accurate Are They

Scientists can use genetic markers, which are genes or part of DNA sequences with fixed locations on certain chromosomes, to identify species or even individuals. Tumor markers are substances typically but not always proteins which are produced by cells in response to cancer, and therefore, tend to be present in elevated levels in cancer patients. Some examples of tumor marker blood tests for different types of cancer include:

Breast Cancer CA15-3/CA27.29 blood test

  • According to a study published in Clinical Chemistry, CA27.29 discriminates primary breast cancer from healthy subjects better than CA15.3, especially in patients with limited disease.

Colorectal Cancer CEA blood test

  • CEA levels become increasingly detectable as colorectal cancer progresses. According to a 2006 article published in Oncology, In a study of 358 patients who presented to surgery with a diagnosis of colon cancer, only 4% of patients with stage I disease had an elevated CEA whereas 25%, 44%, and 65% of patients with stage II, III, and IV disease, respectively, had abnormal levels.

Liver Cancer AFP blood test

  • Unfortunately, the sensitivity and efficacy of AFP tests has been called into question by many scientists. As a 2005 study in Oxford medical journal HPB pointed out, AFP used alone can be helpful if levels are markedly elevated, which occurs in fewer than half of cases at time of diagnosis .

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Do You Need Tests For Later

Imaging tests. If your cancer is stage IIIB or IV, you should get an imaging test to look for cancer in other parts of your body. Treatment can depend on how much and where the cancer has spread.

Tumor marker tests. If you have later-stage breast cancer, your doctor may also use blood tests to look at tumor markers. These tests should be done only when it is known that you have advanced cancer.

This report is for you to use when talking with your healthcare provider. It is not a substitute for medical advice and treatment. Use of this report is at your own risk.


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Oncotype Dx Breast Dcis Score Test

Theres a specific Oncotype DX test for people with ductal carcinoma in situ who have had breast-conserving surgery .

Oncotype DX for DCIS can predict the risk of the cancer coming back after surgery. The results of this test may help you and your treatment team decide whether youre likely to benefit from radiotherapy.

Its not routinely used on the NHS as theres less evidence of its benefits for people with DCIS. Some private healthcare providers may cover the cost and you can also pay for the test yourself. For more information, talk to your treatment team.

How Gep Tests Work

Constituent genes of the Oncotype DX breast cancer assay (adapted from ...

GEP tests look at groups of cancer genes to find out how active they are. The activity of particular genes helps the doctor predict whether a cancer is likely to come back. This in turn can help them decide who needs extra treatment to lower the risk of their cancer coming back.

For example, you might not need to have chemotherapy if the risk of the cancer coming back after surgery and radiotherapy is low. Your doctor is more likely to recommend chemotherapy if the chance of the cancer coming back is higher.

It is important that people dont have unnecessary treatments, because all treatment have some side effects.

In many cases, it is clear to a specialist whether a patient definitely does or does not need further treatment. So these tests might be most useful where there is some uncertainty about the risk of your cancer coming back.

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How Can Genetic Testing Help

Genetic testing can help determine the risk of cancer within a family and guide appropriate cancer screening. Depending on the specific genetic risk, different screening tests can be arranged, and risk-reducing strategies can be considered.

No, if you wish you can choose to be tested for some or all the nine genes in the panel. The number of genes tested will not affect the testing time or pricing.

There are three possible results:

  • A pathogenic variant is found in one of the genes which is known to increase the risk of breast cancer. If you have been diagnosed with cancer, this may change your treatment. Increased screening and/or risk-reducing techniques will be recommended.
  • A variant of unknown significance is found , but whether this is the definite cause of cancer is unknown. Screening will be recommended based on the family history.
  • No pathogenic variants are found. It is possible that there may be an undetectable variant or a variant in a different gene. Cancer screening may still be beneficial.
  • If you have a pathogenic variant this will explain why you and/or your relatives have developed breast cancer and means that you have an increased risk of breast cancer and possibly other cancers. Your exact risk will depend on which gene pathogenic variant has been found. Extra screening and/or risk-reducing strategies will be discussed. It will also be possible to offer predictive testing to other people in your family to see if they also have the pathogenic variant.

    What Is The Oncotype Dx Score For Breast Cancer

    Oncotype DX test results assign a Recurrence Score a number between 0 and 100 to the early-stage breast cancer. Based on your age, you and your doctor can use the following ranges to interpret your results for early-stage invasive cancer. For women older than 50 years of age: Recurrence Score of 0-25: The cancer has a low risk of recurrence.

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    Tumor Characteristics And Histological/immunohistochemical Findings

    Of the total 236 patients, 38% were classified as Grade 1 tumors , 50% were classified as Grade 2 tumors , and 12% were classified as Grade 3 tumors . Of the total 236 cases, 96% were found to be T1 or T2 tumors and 4% were found to be T3 tumors . No cases were found to be T4 tumors. Forty-seven cases were found to have one or more positive lymph nodes, but less than three, , with all of the remaining patients having no metastatic disease to the lymph nodes.

    The IHC staining for ER, PR, and Her-2/neu status were as follows: 99% ER positive and 1.0% ER negative , 95% PR positive and 5% PR negative , 98% Her-2/neu negative and four positive for Her-2/neu by both IHC and FISH respectively. The proliferation index was also determined for each case, and was considered high when Ki-67 was greater than or equal to 20%. Of the 236 total cases, 43 were found to have elevated Ki-67 and 169 were found not to be elevated .

    How To Prepare For An Oncotype Dx Test

    Oncotype DX Breast Cancer Test Impact On Treatment Options

    You dont need to do anything specific to prepare for an Oncotype DX test. Its performed in a laboratory using the cancer cells from a biopsy or surgery. Ask your cancer care team when youre likely to learn the results of the test.

    When it comes to preparing for your biopsy or surgery, your cancer care team will tell you what you need to know. Be sure to speak up and ask questions.

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    What Does The Recurrence Score Mean

    In individuals over the age of 50

    • A score of 0-25 indicates a low risk of recurrence. The risks associated with chemotherapy would outweigh the benefits of having chemotherapy.
    • A score of 26-100 indicates a high risk of recurrence. The benefits of chemotherapy in preventing a future recurrence outweigh the risks.

    In individuals under the age of 50

    • A score of 0-15 indicates a low risk of recurrence. Likely the risks associated with chemotherapy would outweigh the benefits of having chemotherapy.
    • A score of 16-20 indicates a low to medium risk of recurrence. It is likely the benefit of chemotherapy will not outweigh the risks.
    • A score of 21-25 indicates a medium risk of recurrence. The benefits of chemotherapy likely will outweigh the risks of side effects.
    • A score of 26-100 indicates a high risk of recurrence. The benefits of chemotherapy are likely greater than the risks of side effects.

    Why The Oncotype Dx Test Is Done

    The Oncotype DX test is a kind of risk-benefit analysis for personalized breast cancer treatment. It helps determine the treatment plan after breast cancer surgery, based on the cancer cells genetic makeup, while sparing you from the side effects of potentially unnecessary chemotherapy.

    This test helps ascertain the likelihood that breast cancer may recur or spread after surgery.

    • If the test shows a high likelihood of recurrence, you and your care team may consider the benefits of more therapies after surgery.
    • A low chance of recurrence tells your cancer care team that adding chemotherapy to hormone therapy after surgery isnt likely to provide an added benefit.
    • When its used for ductal carcinoma in situ , or stage 0 breast cancer, it may help you and your care team decide whether or not to complete radiation therapy after surgery.

    More patients today are able to bypass chemotherapy after breast cancer surgery. Forgoing chemotherapy that doesnt provide an added benefit means avoiding the negative side effects of the treatment, such as nausea, vomiting, hair loss, fatigue and numbness in the hands or feet.

    For some estrogen receptor-positive and lymph node-negative cancers, the Oncotype DX test may also be usedin addition to other test resultsto determine the stage of breast cancer. So far, its the only gene expression test used in the breast cancer staging process.

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    How Genetic Testing Is Done

    Genetic testing can be done on samples of blood or saliva, or from a swab of the inside of a cheek. The samples are sent to a lab for testing.

    There are many different possible mutations in the BRCA genes. Testing can look for one specific mutation, or more extensive testing can be done to look for many different BRCA mutations. For example, if someone is being tested because they have a family member with a known BRCA mutation, testing might focus only on that specific mutation. In people of Ashkenazi Jewish descent, testing might focus on the specific BRCA mutations that are most common in this group of people. But if theres no reason to suspect a specific gene change, testing will likely look for many different BRCA mutations. Depending on the situation, testing might be done to look for changes in other genes as well.

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    The Oncotype Dx Breast Recurrence Score

    Genomic Health Posts Impressive Data for Oncotype DX Test

    Oncotype Dx® is a genomic laboratory test that helps guide treatment decisions for people with early-stage invasive breast cancers. Genomic tests look at the genes in tumors. This can tell us more about your risk of the cancer coming back. Genomic tests are not the same as genetic tests. Genetic tests look for a single-gene mutation in your body , whereas genomic tests look at the genes in the tumor.

    Genomic tests are a way to look specifically at your tumor for information to help guide your treatment options. There are several genomic tests currently available. This article focuses on the Oncotype DX® breast recurrence score test. This test helps determine if having chemotherapy in addition to endocrine therapy after surgery will lower your risk of the cancer coming back .

    The Oncotype DX® test is endorsed by all major cancer research/treatment organizations, including the National Comprehensive Cancer Network and the American Society of Clinical Oncology . It has been studied extensively and has proven to be a valuable tool in guiding treatment planning for individuals with certain types of breast cancer.

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    Oncotype Dx Score Is 15 Or Lower And Lymph Node

    For premenopausal women with lymph node-negative breast cancer, if the Oncotype DX score is 15 or lower, its unlikely chemotherapy would add much benefit to treatment. So, the use of hormone therapy alone is recommended .

    In this way, Oncotype DX may help some women with ER-positive breast cancer avoid chemotherapy and its side effects.

    Oncotype In Node Negative Early Stage Breast Cancer

    The results from a group of 1,626 patients with a Recurrence Score between 0 and 10 demonstrated that 99.3 percent of node-negative, estrogen receptor-positive, HER2-negative patients who met accepted guidelines for recommending chemotherapy in addition to hormonal therapy had no distant recurrence at five years after treatment with hormonal therapy alone. Outcomes were excellent irrespective of patient age, tumor size, and tumor grade.1

    Many women with the most common type of early stage breast cancer likely do not need chemotherapy after surgery according to the results of the Trial Assigning IndividuaLized Options for Treatment study involving more than 10,000 women with hormone receptor positive, HER2-negative that had not spread to lymph nodes. The study was presented the 2018 American Society of Clinical Oncology meeting and published in the New England Journal of Medicine.3

    Historically only 1 in 10 women with ESBC treated with chemotherapy benefited from that treatment. Physicians however had no way to determine which patient benefited, therefore 9 women received chemotherapy unnecessarily. The results of the current study suggest that chemotherapy can be avoided in about 70% of patients with node negative ESBC.

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    Chemotherapy Improves The Prognosis Of High

    Oncotype DX has been used to decide the use of adjuvant chemotherapy in ER+ breast cancer. We thus performed multivariable Cox regression analysis to examine whether chemotherapy improved the prognosis of patients. As shown in Table , we found that high-risk patients benefited from chemotherapy with the risk of overall death decreasing by 40% after chemotherapy use as compared to high-risk patients with no/unknown chemotherapy use .2). Patients with intermediate-risk also benefited from chemotherapy use compared to intermediate-risk patients with no/unknown chemotherapy use .2). In contrast, chemotherapy was not associated with prolonged OS for patients with low-risk .

    Looking Into A Biological Crystal Ball

    Breast Cancer Recurrence Prediction with Oncotype DX Test

    Several studies are currently looking into the possibility of diagnosing breast cancer at the cellular level. There is hope that someday researchers will be able to identify a turning point when biological substances become cancerous, thus leading to development of methods for detecting warning signals.

    The National Cancer Institute alone has funded research into at least a half-dozen tests that involve examining typical and irregular proteins, molecules, genes, and other biological matter. One such large clinical trial in progress is a blood test. By analyzing concealed patterns of protein in blood, investigators propose being able to distinguish malignant tissues from benign ones.

    Although this blood test is currently being tested only for ovarian cancer, researchers are hopeful the technology, once proven, could be adapted to other cancers. If everything goes well, investigators plan to compare the outcome of the trial with other blood test research around the country of other cancers.

    One such study to detect breast cancer by looking at blood cells has already ended. The results? The blood test was 95% successful in spotting malignancies. The complete report is currently being reviewed for publication in a medical journal.

    Everything looks extremely excitingbut we want to move cautiously, says Lance Liotta, MD, PhD, a principal investigator of the Clinical Proteomics Program, and chief of the laboratory of pathology at the National Cancer Institute.

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    Oncotype Dx Predicts Chemotherapy Benefit In Node

    Among women with node-positive, hormone receptor-positive breast cancer, use of the Oncotype DX test identifies a subset of women who do not appear to benefit from adjuvant anthracycline-based chemotherapy.6

    To assess the test among women with node-positive, hormone receptor-positive breast cancer, researchers evaluated information from 367 patients. Some patients received adjuvant therapy with tamoxifen alone, and some received tamoxifen plus anthracycline-based chemotherapy.

    • The addition of chemotherapy to tamoxifen significantly improved breast cancer survival among women with a high Recurrence Score .
    • The addition of chemotherapy did not improve breast cancer survival among women with a low Recurrence Score.
    • Women with an intermediate or high Recurrence Score had a two- to threefold increase in recurrence risk compared to women with a low Recurrence Score.

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    Gep Tests For Breast Cancer

    There a number of GEP tests. The National Institute for Health and Clinical Excellence has assessed some of these. It recommends that the following tests should be an option for some people with breast cancer to help decide whether chemotherapy is needed after surgery:

    • EndoPredict
    • Oncotype DX Breast Recurrence Score
    • Prosigna

    NICE recommend these tests for people with intermediate grade breast cancer with all of the following:

    • stage 1 or 2 disease
    • no cancer cells in the lymph nodes
    • oestrogen receptors in their cancer cells
    • their cancer cells have a small number of HER2 receptors

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