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Objective ― HER-2/neu assay in gastric cancers is routinely evaluated by immunohistochemistry and fluorescent in situ hybridization methods because the monoclonal antibody trastuzumab developed against HER-2/neu give rise to significant improving on the survival. In the HER-2/neu evaluation, some problems related to the sampling process, analysis method, tumor biology and heterogeinity are encountered. Our aim in the present study was to analyze these evaluation problems on endoscopic biopsy samples and resection materials of our cases with gastric carcinoma. Material and Methods ― The study included 109 gastric cancer cases. The analyses were realized on the resection materials of the 109 cases and the endoscopic mucosa biopsies of 43 out of these 109 cases. Immunohistochemistry was applied on mucosa biopsies and, tumor sections of resections, while fluorescent in situ hybridization was performed on tumor sections of resections (21 cases). The assays results were compared with each other and clinicopathological parameters. Results ― Our rate of HER-2/neu positivity (IHC3+ and IHC2+/FISH+ cases) was 6.42%. The compatibility rate between the rates of overexpression and amplification in resections was 90.5% while the compatibility ratio between the overexpression rates of mucosa samples and resections was 95.4%. The false negativity rate on mucosa biopsies was detected as 4.65%. HER-2/neu status was not correlated with unfavorable clinicopatological features. Conclusion ― Our gene positivity rate was near the lower limit of the range reported in the literature. Our compatibility rate between the results of immunohistochemistry and fluorescent in situ hybridization was over 90%. However our false negativity rate in mucosa biopsy analysis was low according to the literature. In order to preclude false negativity arising from tumor heterogeinity, we think that immunohistochemistry should be applied on the whole section.

HER-2/neu gene analysis on endoscopic biopsy samples and gastric resection materials in gastric carcinomas