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Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes

Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US)

Version: January 2008

Discussion

Using the analytical framework described, we evaluated the evidence available on three commercially available gene expression based assays, and on the gene expression profiles underlying these tests. Specifically, our review focused on the MammaPrint® assay, based on the 70-gene prognostic signature developed by van't Veer and colleagues, on the Oncotype DX™ assay, based on the 21-gene profile developed by Paik and colleagues, and on the Breast Cancer Profiling (BCP) assay, based on the two-gene ratio signature developed by Ma et al.

Results

In a study defined as providing direct evidence of improvement in outcomes, the use of the test in decisionmaking is compared to not using the test, with health outcomes as an endpoint, generally in the form of an RCT. There is currently no direct evidence that the investigated gene expression profiling tests lead to improvement in outcomes in any subset of women diagnosed with breast cancer. Two ongoing RCTs aim to provide almost direct evidence for Oncotype DX™, and for MammaPrint®. These studies are described at the end of this chapter.

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