Authors' recommendations: It is estimated that more than 220,000 new cases of breast cancer will be diagnosed in 2012, making breast cancer the most common malignancy among women in the United States. While the 5-year survival rate for breast cancer localized to the breast is more than 98%, it drops to approximately 24% for women with distant metastases. Breast cancer prognosis and treatment selection are often influenced by specific patient traits and tumor characteristics, such as patient age, menopausal status, tumor size, tumor grade, lymph node involvement, and the expression of the estrogen receptor (ER) and other tumor markers. Patients with early-stage, ER-positive breast cancer are typically offered adjuvant hormone therapy (i.e., treatment with tamoxifen), as this leads to a significant decrease in the risk of distant recurrence. Adjuvant chemotherapy may further reduce the risk of recurrence in some of these patients and lead to improved overall survival. However, because of the significant adverse effects that may occur with cytotoxic chemotherapy, the risks of treatment must be weighed against the potential benefits. While clinical guidelines and computational algorithms based on clinical and pathological factors are available to guide decisions regarding adjuvant chemotherapy, these appear to be of limited effectiveness because of the inherent biological diversity of breast cancers. Therefore, to facilitate the selection of patients who will preferentially benefit from adjuvant chemotherapy, several genomic tests have been developed that use specific gene expression patterns in breast tumors to determine a patient's risk of disease recurrence. While most of these assays involve methods to measure levels of RNA, the Mammostrat test uses immunohistochemistry (IHC) to analyze the expression patterns of five proteins that function in cell cycle regulation, cell differentiation, stress response, and/or nutrient transport. The proteins evaluated in this test, which is designed specifically for patients with nodenegative, ER-positive breast cancer, are tumor protein p53 (TP53), transfer RNA (tRNA) methyltransferase 2 homolog A (TRMT2A), carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), N-myc downstream-regulated gene 1 (NDRG1), and solute carrier family 7 member 5 (SLC7A5). Using a proprietary algorithm, the IHC staining patterns of all five biomarkers are correlated with the risk of distant recurrence over a 10-year period, with patients categorized into three risk groups (low, moderate, and high). It is expected that patients with a high risk of recurrence may choose adjuvant chemotherapy, while patients with a low risk of recurrence may decline such aggressive treatment.

Project Status: Completed

Year Published: 2012

URL for published report: The report may be purchased from:http://www.hayesinc.com/hayes/crd/?crd=14305

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: 2012 Winifred S. Hayes, Inc