目的 运用2013版美国临床肿瘤学会(ASCO)/美国病理医师学院(CAP)乳腺癌HER2检测指南,回顾性地对1 501例浸润性乳腺癌(IBC)的HER2的免疫组织化学(IHC)及荧光原位杂交(FISH)检测结果进行再评估,分析2013版指南对检测结果判读的影响.方法 按照2007版ASCO/CAP指南全面规范手术标本处理及HER2检测技术流程.所有IBC手术标本均常规行HER2IHC检测,对IHC检测显示HER2不确定的患者推荐其行FISH检测.参照两版指南,分别评估1 501例IBC患者的HER2检测结果.结果 1 501例行IHC染色,其中348例行FISH检测.两版指南评估HER2状态阳性率分别为23.05％、23.52％;不确定率分别为11.59％、12.52％;阴性率分别为65.36％、63.96％.采用2013版指南后,阳性率和不确定率分别增加0.47％、0.93％,而阴性率减少1.40％.其中IHC检测结果的阳性率分别为17.99％、18.12％(+0.13％)、不确定率分别为32.51％、32.91％(+0.40％),阴性率分别为49.50％、48.97％(-0.53％);FISH检测结果的阳性率分别为27.59％、29.02％(+1.43％),不确定率分别为1.15％、及3.74％(+2.59％),阴性率分别为71.26％、67.24％(-4.02％).结论 2013版ASCO/CAP指南的采用将使乳腺癌HER2检测阳性率及不确定率有所提高,阴性率下降,尤其对FISH检测结果的影响较大,由于采用HER2平均拷贝数指标,阳性和不确定病例将增加.本组数据中IHC判读结果的变化与指南的预测一致,而FISH判读结果的变化尚需进一步探讨.%Objective To retrospectively evaluate the HER2 status of 1 501 invasive breast cancer (IBC) by immunohistochemistry (IHC) and fluorescent in situ hybridizaion (FISH),and to compare and analyze the changes and their effects,using the 2007 and 2013 American Society of Clinical Oncology/ College of American Pathologist (ASCO/CAP) HER2 testing guidelines.Methods Tissue handling and HER2 testing were performed according the 2007 ASCO/CAP guideline recommendations.The HER2 status of all newly diagnosed IBC were routinely assessed by IHC,and reflex FISH assay was done on all the IHC equivocal (IHC 2 +) cases.The HER2 status of 1 501 cases of IBC was re-evaluated according to these two criteria.Results Using the 2007 and 2013 ASCO/CAP criteria,the overall positive,equivocal and negative rates of HER2 over-expression and/or amplification in the 1 501 IBCs were 23.05％ and 23.52％,11.59％ and 12.52％,and 65.36％ and 63.96％,respectively.The positive and equivocal rates increased by 0.47％ and 0.93％ respectively,but the negative rate decreased by 1.40％ when using the new criteria.For HER2 IHC staining using the 2007 and 2013 guidelines,the positive,equivocal and negative rates were 17.99％ and 18.13％ (+0.13％),32.51％ and 32.91％ (+0.40％) and 49.50％ and 48,97％ (-0.53％),respectively.FISH for HER2 amplification was done in 348 of the 1 501 IBCs,and using the 2007 and 2013 guidelines,the positive,equivocal and negative rates were 27.59％ and 29.02％ (+1.43％),1.15％ and 3.74％ (+2.59％) and 71.26％ and 67.24％ (-4.02％),respectively.Conclusions The application of 2013 ASCO/CAP guideline could lead to an increase in positive and equivocal rates,and a decrease in negative rate.The influence could be more prominent for the evaluation of FISH result,and would raise the positive and equivocal rates since a mean HER2 copy number is used in the new criteria.Our re-estimation of IHC result was concordant with the prediction of the guideline.
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