乳腺癌HER2检测指南2019版与2014版对HER2过表达患者分类影响比较  

Comparison of HER2 expression classification in 392 patients with breast cancer between 2019 and 2014 version of HER2 testing guidelines in breast cancer

作　　者：吴颖 吴坤河[1] 阮红民[1] 凌月仙[1] 郜红艺[1] WU Ying;WU Kun-he;RUAN Hong-min;LING Yue-xian;GAO Hong-yi(Department of Pathology,Guangdong Women and Children Hospital,Guangzhou 511400 R.China)

机构地区：[1]广东省妇幼保健院病理科

出　　处：《中华肿瘤防治杂志》2019年第24期1876-1882,共7页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的2019版乳腺癌人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)检测指南发布,本研究探讨其对HER2状态分类的影响。方法选取广东省妇幼保健院2014-01-01-2018-12-31确诊为浸润性乳腺癌并且HER2免疫组化结果为2+的392例患者,采用荧光标记原位杂交(fluorescence in situ hybridization,FISH)法检测HER2基因扩增情况,分别按照2014版和2019版乳腺癌HER2检测指南对HER2的FISH结果进行分析,比较两版指南HER2阴性和阳性率的变化,同时对各临床病理参数及赫赛汀疗效进行单因素分析(Pearsonχ^2检验),对差异有统计学意义的参数再行多因素二元Logistic回归分析。结果与2014版指南相比,2019版指南使HER2阴性率从70.1%(275/392)增加至81.6%(320/392),阳性率由21.7%(85/392)减少至17.6%(69/392),差异有统计学意义,χ^2=36.044,P<0.001。45例(11.5%)患者的HER2状态被重新分类,其中29例HER2状态由不确定变为阴性,另外16例则由阳性变为阴性。HER2状态改变的病例组中17号染色体拷贝数异常的发生率为53.3%(24/45),高于HER2状态未改变组(8.4%,29/345),差异有统计学意义,χ^2=68.915,P<0.001。HER2状态由阳性变为阴性组患者赫赛汀的治疗有效率为31.3%(5/16),低于HER2状态未发生改变阳性组的64.6%(42/65),差异有统计学意义,χ^2=3.949,P=0.015。HER2状态的重新定义与肿瘤大小(χ^2=31.178,P<0.001)和淋巴结转移(χ^2=46.811,P<0.001)相关,但只有赫赛汀疗效是HER2状态改变的独立影响因素,OR=0.199,P=0.013。结论2019版乳腺癌HER2检测指南将提高HER2阴性率,并且取消FISH结果为不确定的类别,为HER2状态的判定提供了更明确的指导和建议。OBJECTIVE 2019 human epidermal growth factor receptor 2(HER2)testing guidelines in breast cancer have just been published recently.Little is known whether it changed the interpretation of HER2 status.Therefore,this study intends to explore the impact of 2019 guidelines on the HER2 status designation.METHODS A total of 392 invasive breast cancer cases with HER2(2+)by immunohistochemistry between January 1 st,2014 and December 31 st,2018 in Guangdong Women and Children Hospital were enrolled in this study.HER2 gene amplification was detected by FISH and the results were analyzed by 2014 and 2019 guidelines respectively to compare the changes of HER2 negative rate and positive rate.Clinicalpathological parameters and the therapeutic effective rate of Herceptin were analyzed by single factor analysis(Pearsonχ^2 test).The parameters with statistical significance were analyzed by multivariate logistic regression analysis.RESULTS Compared to 2014 guidelines,the HER2 negative rate increased from 70.1%(275/392)to 81.6%(320/392)and the positive rate decreased from 21.7%(85/392)to 17.6%(69/392)(χ^2=36.044,P<0.001)by 2019 guidelines.HER2 status were reclassified in 45 cases(11.5%),of which 29 cases changed from equivocal to negative and16 cases changed from positive to negative.The incidence of chromosome 17 copy number abnormalities in the group of HER2 status changed was higher than that in the HER2 status unchanged group(53.3%vs 8.4%,χ^2=68.915,P<0.001).The therapeutic effective rate of Herceptin in the group with HER2 status changed from positive to negative was lower than that in HER2 remained positive group(31.3%vs 64.6%,χ^2=3.949,P=0.015).HER2 status redefinition were correlated with tumor size(χ^2=31.178,P<0.001)and lymph node metastasis(χ^2=46.811,P<0.001),but only Herceptin efficacy was an independent factor for HER2 status change(OR=0.199,P=0.013).CONCLUSION 2019 HER2 testing guidelines in breast cancer increase HER2 negative rate and eliminate the FISH equivocal category,which may provide much clearer guida

关 键 词：乳腺癌 人类表皮生长因子受体2 荧光原位杂交 赫赛汀 

分 类 号：R737.9[医药卫生—肿瘤]