Xu Bin, Shen Jianguo, Guo Wenhao, Zhao Wenhe, Zhuang Yiyu, Wang Linbo
Department of Surgical Oncology, Zhejiang University Medical School Affiliated Sir Run Run Shaw Hospital, 3 East Qingchun Road, Hangzhou, Zhejiang 310016, China.
Department of pathology, Zhejiang University Medical School Affiliated Sir Run Run Shaw Hospital, 3 East Qingchun Road, Hangzhou, Zhejiang 310016, China.
Pathol Res Pract. 2019 Feb;215(2):251-255. doi: 10.1016/j.prp.2018.10.035. Epub 2018 Nov 2.
Recently, the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) updated the guidelines on HER2 testing for invasive breast cancer. Little is known about the impact of the guidelines update. We aimed to study the impact of the 2018 ASCO/CAP HER2 testing guidelines update. We compared the HER2 FISH results interpreted by 2013 and 2018 ASCO/CAP guidelines in 331 cases of invasive breast cancers. We also analyzed the pathological features and clinical outcomes of these cases. In comparing to the 2013 ASCO/CAP guidelines, the HER2 negative rate was increased significantly from 62.5% to 75.8%(P < 0.05), and 13.3% changed from equivocal to negative by the 2018 guidelines. Our findings indicate that the guidelines update significantly increased the rate of negative results. The reclassification of the equivocal results by the 2018 guidelines is the main reason for this change. Patients with HER2 equivocal results were associated with larger tumor size and higher Ki67 index than those with negative results, while clinical outcomes were similar between them.
最近，美国临床肿瘤学会/美国病理学家学会（ASCO/CAP）更新了浸润性乳腺癌HER2检测指南。关于该指南更新的影响知之甚少。我们旨在研究2018年ASCO/CAP HER2检测指南更新的影响。我们比较了331例浸润性乳腺癌中依据2013年和2018年ASCO/CAP指南解读的HER2 FISH结果。我们还分析了这些病例的病理特征和临床结局。与2013年ASCO/CAP指南相比，HER2阴性率从62.5%显著增至75.8%（P＜0.05），并且依据2018年指南，13.3%的结果从可疑变为阴性。我们的研究结果表明，指南更新显著提高了阴性结果的比例。2018年指南对可疑结果的重新分类是这一变化的主要原因。HER2结果可疑的患者与HER2结果阴性的患者相比，肿瘤体积更大，Ki67指数更高，而他们之间的临床结局相似。
