免疫组织化学法与荧光原位杂交技术检测乳腺癌HER-2状态一致性的对比研究

A comparison of IHC and FISH in the evaluation of HER-2 status in breast cancer patients

目的对比研究免疫组织化学法(IHC)与荧光原位杂交技术(FISH)检测乳腺癌人类表皮生长因子受体2(HER-2)蛋白表达和基因状态的一致性,并评价其临床意义。方法采用IHC法及FISH法分别检测1 032例乳腺癌患者术后石蜡包埋标本的HER-2蛋白表达和HER-2基因状态,并进行对比分析。结果 1 032例乳腺癌患者术后石蜡包埋标本,用IHC检测HER-2蛋白表达阳性者373例,占36.1%(373/1 032);表达阴性者659例,占63.9%(659/1 032)。FISH检测HER-2基因扩增325例,占31.5%(325/1 032);基因非扩增707例,占68.5%(707/1 032)。373例HER-2蛋白为阳性的患者中,HER-2基因扩增293例,符合率为78.6%(293/373);659例HER-2蛋白为阴性的患者中,HER-2基因非扩增627例,符合率为95.1%(627/659)。2种方法检测结果比较一致性较好(Kappa=0.758 1,P<0.000 1)。结论 IHC检测乳腺癌HER-2蛋白与FISH检测HER-2基因结果一致性较高。

ObjectiveTo investigate HER-2/neu gene amplification by FISH in breast carcinoma tissue specimens and compared the results with that of immunohistochemical(IHC)analysis.MethodsIHC and FISH were used to detect the expression of HER-2 protein and amplification of HER-2 gene,respectively,in paraffin-embedded tissues from 1 032 patients with breast cancer,the conformity between the results obtained by IHC and FISH was studied.ResultsAmong 1 032 cases of paraffin-embedded specimens of breast cancer patients,373 cases(36.1%)were positive by IHC,while 659 cases were negative(63.9%);HER-2 gene amplification was found in 325 patients(31.5%)by FISH,gene non-amplification in 707 cases(68.5%).In 373 patients whose HER-2 proteins were positive,HER-2 gene amplification was found in 293 cases,resulted in a coincidence of 78.6%(293/373).In 659 patients whose HER-2 proteins were negative,HER-2 gene non-amplification was found in 627 cases,resulted in a coincidence of 95.1%(627/659).The kappa test result showed that(Kappa=0.7581,P<0.000 1),there was good agreement between the two methods.ConclusionThere were a high coincidence between the HER-2 gene examined by FISH and the HER-2 protein detected with IHC.