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The assessment of human epidermal growth factor receptor 2 ( HER 2) status is crucial for selecting patients with gastric cancer who may benefit from  HER 2‐targeted therapy. Accurate assessment using biopsy specimens is important for patients with advanced‐stage cancer. Intratumoral heterogeneity of  HER 2, however, is a major challenge in  HER 2 testing. Here, we aimed to examine whether assessment of  HER 2 status could be accurately carried out with currently used methods, namely, immunohistochemistry ( IHC ),  FISH , and dual‐color  in situ  hybridization ( DISH ). Human epidermal growth factor receptor 2 status was evaluated in 108 biopsy tissues from patients with gastric adenocarcinoma and 70 matched surgical specimens by  IHC ,  FISH , and  DISH ;  HER 2 amplification was detected in 11 (10.2%) out of 108 biopsy specimens. The  IHC  and  FISH  results were well correlated, and  FISH  and  DISH  results were consistent for all cases. The overall concordance rate of  HER 2 status between biopsy tissues and surgical specimens was 91.4%. All six discordant cases were false negative on biopsy; of these cases, five showed  HER 2 heterogeneity on surgical resection. Assessment of the  HER 2 status of biopsy tissues could predict the status of the whole tumor; however, a proportion of these cases may be discordant because of intratumoral heterogeneity.

cancer science

Significant intratumoral heterogeneity of human epidermal growth factor receptor 2 status in gastric cancer: A comparative study of immunohistochemistry,  FISH , and dual‐color  in situ  hybridization