FISH和IHC检测HER2基因及蛋白在乳腺癌诊治中的应用

DETECTION OF HER-2 GENE BY FISH AND IHC IN DIAGNOSIS AND TREATMENT OF BREST CANCER

目的对比研究免疫组织化学（IHC）与荧光原位杂交（FISH）方法检测乳腺癌中C-erbB-2蛋白表达和HER2基因扩增,评估两种方法的实际应用价值。方法 IHC和FISH法分别检测58例乳腺癌组织中C-erbB-2蛋白表达和HER2基因扩增状况,并进行一致性分析。结果IHC检测蛋白阳性2＋和3＋共22例,占总病例的37.9%,58例乳腺癌中FISH检测出HER2基因扩增17例,占29.3%。IHC检测C-erbB-2蛋白3＋的12例中11例HER2基因扩增阳性,1例无扩增;C-erbB-2蛋白2＋者10例,其中5例可见HER2基因扩增;C-erbB-2蛋白1＋者11例HER2基因扩增仅1例。C-erbB-2蛋白阴性病例共25例均未检测到基因扩增。结果显示IHC检测C-erbB-2蛋白与FISH检测HER2基因扩增状态有较高的一致性（k=0.681,P〈0.01）,C-erbB-2蛋白阴性和3＋标本与HER2基因扩增阳性率比较差异无统计学意义（P〉0.05）;而C-erbB-2蛋白1＋和2＋病例与其HER2基因扩增差异具有统计学意义（P〈0.05）。结果 IHC检测C-erbB-2蛋白强阳性（3＋）和阴性（0）与HER2基因扩增有较高的一致性,可作为临床是否应用Herceptin治疗的依据,而C-erbB-2蛋白2＋和1＋病例必须进一步行HER2基因扩增检测。

Objective To compare the clinical significance between detecting C-erbB2 protein expression by immunohistochemistry（IHC） and detecting Her-2 gene amplification by flurescence in situ hybridization（FISH） in breast cancer.Methods The expression of C-erbB2 protein and Her-2 gene amplification in 58 cases of breast cancer were detected by IHC and FISH respectively,and the concordance between them was analyzed.Results Of 58 cases,the expression of C-erbB2 protein was strongly and moderately positive in 22 cases（37.9%）,and the Her-2 gene amplification existed in 17 cases（29.3%）.In 12 cases where the expression of C-erbB2 protein was strongly positive by IHC,Her-2 gene amplification exsited in 11 cases.In 10 cases where the expression of C-erbB2 was moderately positive,Her-2 gene amplification exsited in 5 cases.In 11 C-erbB2 weakly positive cases,Her-2 gene amplication exsited in only 1 case.But in 25 C-erbB2 negative cases,none was amplied.Those data showed good concordance between the two methods,（κ=0.681,P0.01）.In addition,for the cases with strongly positive or negative expression,the difference between IHC and FISH was not statistically significant（P0.05）,but for the cases with moderately and weakly positive expression,the difference was statistically significant（P0.05）.Conclusion There is favourable concordance between Her-2 gene amplification and strongly positive or negative c-erB2 expression.It can be a evidence to decide whether use herceptin in clinical therapy or not.But for the moderately and weakly positive cases,FISH must be applied.