Abstract
HER2-positive metastatic colorectal cancer (mCRC) is a distinct subtype for which HER2-targeted therapy is established. HER2 intratumoral heterogeneity (ITH), containing two types of heterogeneity–genetic heterogeneity (GH, a mixture of HER2 positive and negative tumor cells) and non-genetic heterogeneity (NGH, a mixture of HER2 positive tumor cells and amplified HER2 gene tumor cells without HER2 protein expression)– is a predictor of response to HER2-targeted treatment in breast cancer (BC). Here, using samples with mCRC, we evaluated the diagnostic accuracy of the Gene-Protein Assay (GPA), an assay assessing HER2 ITH by a combined HER2 immunohistochemistry (IHC) and bright-field HER2 in situ hybridization (ISH) on the same tissue section, and the frequency of HER2 ITH and heterogeneous patterns.
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