运用《乳腺癌HER2检测指南(2019版)》对免疫组织化学检测HER2不确定表达状态的再评估  

Reevaluation of equivocal HER2 status detected by immunohistochemistry according to the 2019 guidelines for HER2 detection

作　　者：徐伟铭[1] 张玲娜[1] 金海丽 周晶晶[1] 王紫怡 翁寿向[1] 李玉晶[1] 周嫔[1] 甘梅富[1] Xu Weiming;Zhang Lingna;Jin Haili;Zhou Jingjing;Wang Ziyi;Weng Shouxiang;Li Yujing;Zhou Pin;Gan Meifu(Department of Pathology,Taizhou Hospital of Zhejiang Province,Taizhou 317000,China)

机构地区：[1]浙江省台州医院病理科,317000

出　　处：《中华病理学杂志》2020年第11期1152-1157,共6页Chinese Journal of Pathology

基　　金：浙江省台州市科技计划(1802ky08)。

摘　　要：目的探讨《乳腺癌HER2检测指南(2019版)》对HER2基因扩增状态的检测结果影响及其临床意义。方法根据2014版《乳腺癌HER2检测指南》判读标准选取浙江省台州恩泽医疗中心病理学部2013—2019年所有免疫组织化学(IHC)检测HER2不确定(2+)并行荧光原位杂交(FISH)技术检测的浸润性乳腺癌548例,运用2019版指南对IHC结果和HER2/CEPl7双探针FISH检测结果进行重新评判并分组。结果548例IHC HER22+的浸润性乳腺癌中,按照2014版检测指南,FISH检测结果为HER2阳性96例(17.52%)、不确定81例(14.78%)、阴性371例(67.70%);而根据新的2019版检测指南评判,IHC检测有10例(1.82%)被判读为1+,FISH检测结果第2组2例直接判为阴性,第4组原本不确定的病例也均判为阴性,最终548例FISH检测结果为HER2阳性94例(17.15%)、阴性454例(82.85%)。结论应用2019版指南后,IHC HER22+数量略有下降,FISH检测结果因为第2组和第4组的病例解释发生变化,导致HER2阳性率略有下降,从而对2014版本判定的不确定病例进行了重新分类。总体来说,新版指南更加合理、可操作性更好。Objective To understand the effects and clinical significance of the 2019 guidelines for the human epidermal growth factor receptor 2(HER2)detection.Methods According to the 2014 guidelines,548 cases of invasive breast cancer with equivocal HER2(2+)detected by immunohistochemistry(IHC)in Taizhou Enze Medical Center,Zhejiang Province,China from 2013 to 2019 were selected.The results of IHC and HER2/CEPl7 double-probe were reevaluated and divided into groups according to the 2019 guidelines for the comparative analysis.Results Among the 548 IHC HER2(2+)invasive breast cancers,the number of positive,equivocal and negative cases for HER2 were 96(17.52%),81(14.78%)and 371(67.70%),respectively,according to the 2014 guidelines.However,according to the 2019 guidelines,10 cases(1.82%)were reclassified as IHC 1+,2 cases in the group 2 were reclassified as negative,and all the originally equivocal cases in group 4 were reclassified as negative.Finally,the total number of positive and negative cases for HER2 were 94(17.15%)and 454(82.85%),respectively.Conclusions After applying the 2019 guidelines,the number of IHC 2+cases decreases,and the positive rate for HER2 also decreases slightly due to the reevaluation change in groups 2 and 4,leading to reclassification of the cases that were deemed equivocal according to the 2014 guidelines.In general,the new 2019 guidelines are more reasonable and easier to use.

关 键 词：乳腺肿瘤 基因 ERBB-2 原位杂交 荧光 免疫组织化学 

分 类 号：R737.9[医药卫生—肿瘤]