摘要目的 通过比较双色银染原位杂交(DSISH)和免疫组织化学检测胃癌HER2基因扩增和蛋白表达结果的一致性和差异性,探讨DSISH检测胃癌HER2基因状态的应用价值.方法 采用DSISH与免疫组织化学检测230例胃癌组织中HER2状态.结果 230例胃癌组织中,DSISH检测HER2基因扩增43例,无扩增187例,HER2基因扩增率为18.7％ (43/230);免疫组织化学检测HER2蛋白无表达115例,1+ 69例,2+ 15例,3+31例,HER2蛋白阳性表达率为13.5％(31/230).其中43例HER2基因扩增的胃癌组织中,HER2蛋白无表达2例,1+ 10例,2+2例,3+ 29例;187例HER2基因无扩增的胃癌组织中,HER2蛋白无表达113例,1+ 59例,2+ 13例,3+2例.DSISH检测胃癌HER2基因扩增与免疫组织化学检测HER蛋白表达的总体符合率为93.5％(201/215),具有高度的一致性(Kappa=0.767,P＜0.01).结论 DSISH可以应用于胃癌HER2基因检测,并与免疫组织化学检测结果具有高度的一致性;由于HER2表达存在异质性,当免疫组织化学检测胃癌HER2蛋白2+时,应该进一步检测HER2基因扩增情况.

abstractsObjective To investigate the concordance of dual-color silver enhanced in-situ hybridization (DSISH) and immunohistochemistry (IHC) in the detection of HER2 gene amplification and expression and to evaluate the values of DSISH in detecting HER2 gene status in gastric carcinoma.Methods By using automated DSISH and IHC,HER2 gene status was detected in 230 cases of gastric cancer.Results Among the 230 cases of gastric carcinoma tested by DSISH,43 cases were positive and 187 cases were negative; HER2 gene amplification rate was 18.7％ (43/230).The expression of HER2 protein was negative,weakly,moderately and strongly positive in 115,69,15 and 31 cases,respectively,by IHC.HER2 protein positive rate was 13.5 ％ (31/230).Of the 43 HER2 gene amplification cases by DSISH,2,10,2 and 29 cases were negative,weakly,moderately and strongly positive by IHC; Of the 187 HER2 negative cases by DSISH,113,59,13 and 2 cases were negative,weakly,moderately and strongly positive by IHC,respectively.The overall concordance of HER2 status in the investigation between IHC and DSIDH was 93.5％ (201/215),with a high consistency (Kappa coefficient 0.767,P ＜ 0.01).Conclusions DSISH can be applied to detect the HER2 gene status in gastric cancer and it also has a high consistency with the result of IHC.In addition,due to frequent heterogeneous expression of HER2,cases with moderate HER2 protein expression may need further assessment by DSISH.