2019版乳腺癌HER-2检测指南对FISH可疑阳性病例判读及其预后分析

2019 edition of breast cancer HER-2 detection guidelines for the interpretation and prognosis analysis of FISH suspicious positive cases

目的比较2014版与2019版乳腺癌HER-2检测指南的差异,探讨2014版指南免疫组化HER-22+、FISH结果为可疑阳性病例的临床病理特征,及两版指南不同判读结果与患者预后的关系。方法收集浸润性乳腺癌(invasive breast cancer,IBC)3483例,依据2014版指南免疫组化HER-22+、FISH检测诊断为可疑阳性93例,根据2019版指南进行重新判读。收集该93例患者临床病理资料并随访,分析不同指南判读对患者预后的影响。结果3483例IBC中,免疫组化HER-20为635例(18.23%),HER-21+为544例(15.62%),HER-22+为1419例(40.74%),HER-23+为885例(25.41%)。1419例HER-22+行FISH检测,2014版指南判读阳性212例,阴性1114例,可疑93例。其中,2014版指南判读93例可疑病例经2019版指南重新判读改为阴性,两版指南判读结果差异有显著性(P<0.05)。93例患者中行抗HER-2治疗7例(7.53%),出现复发转移1例(1.08%);未行抗HER-2治疗组86例(92.47%),出现复发转移3例(3.23%),Kaplan-Meier生存分析Log-rank检验显示差异无统计学意义(χ^(2)=1.471,P=0.225)。这类患者是否行抗HER-2治疗,其预后及生存时间差异无统计学意义(P>0.05)。结论2019版乳腺癌HER-2检测指南对可疑阳性病例进行重新分类,在临床实践应用中具有更好的适用性。

Purpose To compare the differences between the 2014 version and the 2019 version of the guideline for HER-2 detection of breast cancer,and to explore the relationship between HER-2 expression and clinicopathological characteristics and prognosis of breast patients that the result of immunohistochemistry(IHC)is 2+,and the result of fluorescence in situ hybridization(FISH)is suspected to be positive.Methods The invasive breast cancer(IBC)cases were collected and the cases diagnosed as HER-2 suspected positive by FISH test according to the 2014 version of the guidelines were re-interpreted according to the 2019 version of the guidelines,and 93 cases were diagnosed as negative for HER-2.The clinicopathological data of the 93 patients were collected and followed up to analyze the impact of different guidelines on the prognosis of the patients.Results Among 3483 patients with invasive breast cancer,immunohistochemical HER-20 was 635(18.23%),HER-21+was 544(15.62%),HER-22+was 1419(40.74%),and HER-23+was 885 cases(25.41%).1419 cases of HER-22+were tested by FISH,and the 2014 guidelines interpreted 212 cases as positive,1114 cases as negative,and 93 cases as suspicious.Among them,93 suspicious patients interpreted by the 2014 version of the HER-2 guideline were changed to negative after re-interpretation of the 2019 version of the guideline.After statistical analysis,the interpretation results of the two versions of the guidelines were significantly different(P<0.05).Among the 93 patients,7 cases(7.53%)received anti-HER-2 treatment,in which 1 case(1.08%)had recurrence and metastasis.86 cases(92.47%)did not receive anti-HER-2 treatment,in which 3 cases(3.23%)had recurrence and metastasis.Using the Log-rank test in Kaplan-Meier survival analysis,the difference was not statistically significant(χ^(2)=1.471,P=0.225).Whether or not these patients received anti-HER-2 treatment,there was no statistically significant difference in prognosis and survival time(P>0.05).Conclusion The 2019 breast cancer HER-2 detection guidelines reclassify suspected positive cases and have better applicability in clinical practice.