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Read this today, hope it helps.
Use of Genomic Assays
Identification of molecular markers with prognostic significance may help patients avoid treatment that is unlikely to be successful. Clinical studies have demonstrated that adding adjuvant chemotherapy to tamoxifen in the treatment of node-negative, hormone receptor–positive breast cancer improves disease outcome. However, treatment with tamoxifen alone is associated with a 15% likelihood of distant recurrence at 10 years in this population, suggesting that 85% of these patients would do well without the addition of cytotoxic chemotherapy while avoiding the adverse events inherent to such treatment.[1] Nevertheless, the current National Comprehensive Cancer Network[2] and St Gallen[3] clinical practice guidelines, utilizing classic histopathologic and immunohistochemical prognostic markers, categorize less than 10% of these patients at a risk of recurrence low enough to forgo adjuvant chemotherapy.
OncotypeDX is a genetic test developed in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP). The specific goal of this collaboration was to identify a set of reproducible prognostic factors for patients with node-negative, ER-positive breast cancer who had been treated with tamoxifen for 5 years. Notably, this assay was designed to identify continuous risk factors rather than dichotomous ones, with the understanding that the biologic spectrum of breast cancer is a continuous process rather than a fixed, immutable entity. Three independent cohorts were used to examine 250 genes by individual quantitative real-time polymerase chain reaction, and 16 cancer genes were selected based on their robustness as prognosticators.
A mathematical algorithm known as recurrence score was developed based on expression levels of these 16 cancer genes. An independent clinical cohort from the tamoxifen arm of NSABP trial B-14 was used to assess the utility of this algorithm. The investigators found that recurrence score was a valid measure of continuous risk, with an increased score correlating significantly with increased risk of locoregional and distant relapse, as well as death.[4] This relatively novel technology allows clinicians to assess risk and potential benefit from therapy and helps avoids undertreatment or overtreatment.
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