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CancerQuest > Introduction to Patient Information > Introduction to Cancer Detection and Diagnosis > Molecular Detection and Analysis of Cancer > Oncotype DX® for Breast Cancer

Oncotype DX® for Breast Cancer

Oncotype DX^® for Breast Cancer

What the test does.

Oncotype DX^® for breast cancer was developed by Genomic Health.⁽¹⁾ The purpose of the test is to predict how likely breast cancer is to return (recur) within 10 years.  The test is performed on a sample of tumor tissue collected during biopsy/lumpectomy/mastectomy.  The test measures the activity of 16 genes that have been shown to be important in the growth and/or spread of breast cancer and the activity of 5 reference (unrelated) genes.

Which patients should consider Oncotype DX^®:

Women of any age who were recently diagnosed with Stage I or II lymph node negative, estrogen receptor positive (ER+) breast cancer can consider testing in order to help determine whether chemotherapy would be of benefit to them.

Post-menopausal women recently diagnoses with lymph node positive cancer may also be able to use the test.

What are results of Oncotype DX^®

The main result of the testing is a Recurrence Score^®.  The score is reported on a scale of 0-100, based on the activity levels of the 21 genes.   The score is used to make two different predictions.

1. What is the likelihood that the breast cancer will return at a distant site (i.e. lungs, liver, etc.) within 10 years if the patient takes only tamoxifen.
2. What would the benefit be to the patient of adding chemotherapy to their treatment?

The results contain graphs that include the patient’s result.  Any patient who is not confident in their ability to interpret the results should discuss them with a qualified individual.  The predictions are based on clinical trials using OncoTypeDX^®.  All patients in the studies used to validate the test took tamoxifen, a hormonal breast cancer treatment.^(2)(3)(4)

In general, patients with low Recurrence Scores^® are less likely to have their cancer recur and less likely to benefit from the addition of chemotherapy to their treatment.   In the studies done to prove the accuracy of the Oncotype DX® test, the chemotherapy drugs used were methotrexate and fluorouracil with or without cyclophosphamide.

The report also includes detailed information on the results for three of the 21 genes examined in the test.  They are 1) the estrogen receptor (ER), 2) the progesterone receptor (PR), and 3) the epidermal growth factor receptor 2 (HER2).   The ER and HER2 genes are specifically listed out because the levels of the protein products of these genes are linked to responses to hormonal and antibody-based treatments for breast cancer.

The cost of this test is covered by many insurance companies and is recommended for specific types of patients by the American Society for Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).⁽⁵⁾⁽⁶⁾

References for this page:

1. Oncotype DX® for breast cancer. Genomic Health Website. [http://www.oncotypedx.com/en-US/Breast.aspx]
2. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.N Engl J Med. 2004 Dec 30;351(27):2817-26. Epub 2004 Dec 10. [http://www.nejm.org/doi/full/10.1056/NEJMoa041588] [PUBMED]
3. Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010 Jan;11(1):55-65. Epub 2009 Dec 10. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970314-6/abstract] [PUBMED]
4. Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino JP, Geyer CE Jr, Wickerham DL, Wolmark N. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006 Aug 10;24(23):3726-34. Epub 2006 May 23. [http://jco.ascopubs.org/content/24/23/3726.abstract] [PUBMED]
5. NCCN Guidelines for breast cancer: Oncotype DX recommendation. Accessed 12-07-2011 [http://www.nccn.com/files/cancer-guidelines/breast/index.html#/22/zoomed]
6. Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S, Somerfield MR, Hayes DF, Bast RC Jr; American Society of Clinical Oncology. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007 Nov 20;25(33):5287-312. Epub 2007 Oct 22. [http://jco.ascopubs.org/content/25/33/5287.abstract] [PUBMED]