| Summary: | Oncotype DX (ODX) is a gene expression profiling test designed to measure the 10-year risk of tumor recurrence in early breast cancer following initial diagnosis. The risk of tumor recurrence is reported as a 21-gene signature or recurrence score (RS) on a scale of 0-100; this RS is then translated into one of three categories of risk: low (RS<18), intermediate (RS 18-30), or high (RS>30). In the adjuvant setting, results from gene expression profiling tests aim to complement traditional prognostic information obtained from clinicopathologic findings by adding better risk stratification, which may then assist in the identification of patients most likely to benefit from adjuvant chemotherapy. Initially developed in women with estrogen receptor-positive (ER+) and lymph node-negative (LN) early invasive breast cancer, the use of ODX has since expanded into other settings, including the lymph node-positive (LN+) population. Because invasive breast cancer is LN at diagnosis in 65% of women and is where the bulk of the evidence base for ODX resides, it is unclear to what extent, if any, the less commonly-presenting LN+ population may benefit from ODX testing in the adjuvant treatment setting
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