Background: We performed this meta-analysis study to evaluate the concordance and discordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in detecting HER2 alteration in human breast cancer.
Methods: As a meta-analysis, the present study evaluated the available data from previous studies on the HER2 gene detected by IHC and FISH. To indicate the meta-analysis results, a forest plot was used.
Results: We identified 172 citations, for which our inclusion criteria were met by 18 articles, representing 6629 cases. The overall concordance and discordance rate between IHC staining with score 0/1+ and FISH for detection failure of HER2 expression was 96 and 4 %, respectively. The present study showed that the overall proportion of FISH positive and negative rate for IHC score 2+ for detection of HER2 expression was 36 and 64 %, respectively; and 91 and 9 % for 3+ IHC scores.
Conclusion: The results of this study show that IHC score 0/1+ and 3+ cannot be completely considered as negative and positive breast cancer test, respectively. Therefore, we suggest a valid and complementary test, the same as FISH, to explore HER2 expression.
Keywords: Breast cancer; Fluorescence in situ hybridization; HER2; Immunohistochemistry; Meta-analysis.