2019版中国乳腺癌HER-2检测指南对HER-2免疫组化检测结果为不确定的浸润性乳腺癌荧光原位杂交检测结果判读的影响及临床意义  

Impact and clinical value of the revised 2019 Chinese HER-2 testing guidelines on the detect result evaluation of invasive breast cancer cases with equivocal HER-2 immunostaining by using fluorescence in situ hybridization

作　　者：张岚[1] 王伟伟 姜国忠[1] 张延平[1] Zhang Lan;Wang Weiwei;Jiang Guozhong;Zhang Yanping(Department of Pathology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China)

机构地区：[1]郑州大学第一附属医院病理科,450000

出　　处：《中华肿瘤杂志》2021年第8期833-837,共5页Chinese Journal of Oncology

基　　金：河南省科技攻关项目(192102310057)。

摘　　要：目的探讨2019版中国乳腺癌人表皮生长因子受体2(HER-2)检测指南对浸润性乳腺癌免疫组化(IHC)检测HER-2(++)患者荧光原位杂交(FISH)检测结果判读的影响及其临床意义。方法选取2019年5—11月郑州大学第一附属医院收治的569例浸润性乳腺癌患者,根据2014版和2019版乳腺癌HER-2检测指南IHC检测结果判读均为HER-2(++)。进一步行HER-2/17号染色体着丝粒(CEP17)双探针FISH检测,分别根据2014版和2019版乳腺癌HER-2检测指南对检测结果进行判读,分析2019版指南对HER-2检测结果判读的影响。结果根据2014版指南判读,569例患者中,HER-2阳性139例(24.43%),HER-2阴性363例(63.80%),不确定67例(11.78%)。根据2019版指南判读,569例患者中,第1组115例(20.21%),第2组9例(1.58%),第3组15例(2.64%),第4组67例(11.78%),第5组363例(63.80%);HER-2阳性130例(22.85%),HER-2阴性439例(77.15%)。与2014版指南比较,根据2019版指南判读后HER-2阳性率由24.43%(139/569)降低为22.85%(130/569),差异无统计学意义(χ^(2)=0.394,P=0.577);HER-2阴性率由63.80%(363/569)增加到77.15%(439/569),差异有统计学意义(χ^(2)=24.392,P<0.05)。43例IHC不完整的弱至中等强度细胞膜染色、根据2014版指南判读为HER-2(++)、根据2019版指南判读为HER-2(+)的患者,其FISH检测结果根据2014版指南判读,HER-2阳性1例(2.33%),不确定6例(13.95%),HER-2阴性36例(83.72%);根据2019版指南判读,43例患者均为HER-2阴性。结论按照2019版指南判读IHC检测HER-2(++)患者的FISH检测结果,部分患者由根据2014版指南判读的HER-2(++)变为HER-2(+),使FISH检测的HER-2阳性率出现小幅度降低,HER-2阴性率升高,并消除了FISH检测不确定的结果,为筛选HER-2靶向治疗获益患者提供了更为明确的参考。Objective To investigate the impact and clinical significance of the revised 2019 Chinese HER-2 testing guidelines on the detecting result evaluation of invasive breast cancers with equivocal HER-2 immunostaining by using fluorescence in situ hybridization(FISH).Methods A total of 569 cases of invasive breast cancers with HER-2(++)immunostaining evaluated according to the immunohistochemistry(IHC)guidelines of 2014 edition and 2019 edition from May to November 2019 were collected and further detected by FISH.The results of HER-2/CEPl7 double probe were respectively interpreted according to both the 2014 and 2019 Chinese HER-2 testing guidelines and the results were compared.Results According to the 2014 guidelines,the number of HER-2 positive,equivocal and negative cases were 139(24.43%),67(11.78%),and 363(63.80%),respectively.Whereas according to the 2019 guidelines,115 cases(20.21%)were the first group,9 cases(1.58%)were the second group,15 cases(2.64%)were the third group,67 cases(11.78%)were the fourth group,and 363 cases were(63.80%)the fifth group,of which 130 cases(22.85%)were positive and 439 cases(77.15%)were negative by FISH detecting.Compared with the guideline of 2014 edition,the HER-2 positive rate of FISH detection reduced from 24.43%(139/569)to 22.85%(130/559)according to the application of the guideline of 2019 edition,but the difference was not statistically significant(P=0.567),while the negative rate increased from 63.80%(363/569)to 77.15%(439/569),with a statistically significant difference(P<0.05).Forty-three cases with incomplete weak to medium intensity of IHC membrane staining which were HER-2(++)according to 2014 guideline were changed to IHC(+)on the basis of the 2019 guideline.According to the FISH guideline of 2014 edition,1 case(2.33%)was positive,6 cases(13.95%)was equivocal and 36 cases(83.72%)was negative,while according to the 2019 FISH guideline,all of the 43 cases were negative.Conclusions According to the guideline of 2019 edition,a proportion of cases changes from HER-2(++)to(

关 键 词：乳腺肿瘤 人表皮生长因子受体2 免疫组织化学 荧光原位杂交 指南 

分 类 号：R737.9[医药卫生—肿瘤]