回顾性基于人群的 HER2 免疫组化和荧光原位杂交在乳腺癌中的比较：2007 年美国临床肿瘤学会/美国病理学家学院标准的影响。
A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas: impact of 2007 American Society of Clinical Oncology/College of American Pathologists criteria.
机构信息
From the Department of Pathology, Yale School of Medicine, New Haven, Connecticut (Drs Schalper, Kumar, Hui, Rimm, and Gershkovich) and Servicio de Anatomia Patologica, Clinica Alemana de Santiago, Chile (Dr Schalper).
出版信息
Arch Pathol Lab Med. 2014 Feb;138(2):213-9. doi: 10.5858/arpa.2012-0617-OA. Epub 2013 Oct 28.
CONTEXT
In 2007 the American Society of Clinical Oncology/College of American Pathologists made new recommendations for HER2 testing and redefined HER2 positivity.
OBJECTIVE
To analyze results from simultaneous HER2 testing with immunohistochemistry and fluorescence in situ hybridization (FISH) in 2590 invasive breast carcinomas between 2002 and 2010, using 2 scoring systems.
DESIGN
Cases from between 2002 and 2006 were scored by using original US Food and Drug Administration criteria (N = 1138) and those from between 2007 and 2010 were evaluated according to American Society of Clinical Oncology/College of American Pathologists criteria (N = 1452). Concordance between testing methods and clinicopathologic associations were determined.
RESULTS
Overall concordance between immunohistochemistry/FISH in the 9-year period was 96.2% (κ = 0.82), and positive concordance was lower. After 2007, the proportion of HER2/neu-positive and HER2/neu-negative cases was not significantly changed when using immunohistochemistry (10.5% versus 8.9%, P = .22 and 69.4% versus 63%, P = .13, respectively), but the number of equivocal cases was higher (19.9% versus 28%, P < .001). While the proportion of negative cases by FISH remained unchanged after 2007 (86.5% versus 88.2%, P = .76), the number of positive cases was lower (13.4% versus 9.2%, P < .001). In addition, 38 cases (2.6%) were FISH equivocal, 16 of which were also equivocal by immunohistochemistry. Overall, immunohistochemistry/FISH concordance was 95.9% between 2002 and 2006 (κ = 0.82) and 96.4% after 2007 (κ = 0.82). However, an approximately 13% lower positive assay concordance was noted in the last period.
CONCLUSIONS
Application of American Society of Clinical Oncology/College of American Pathologists recommendations is associated with comparable overall immunohistochemistry/FISH concordance, reduced positive concordance, and increased equivocal results.
背景
2007 年，美国临床肿瘤学会/美国病理学家学院对 HER2 检测提出了新的建议，并重新定义了 HER2 阳性。
目的
分析 2002 年至 2010 年间使用 2 种评分系统对 2590 例浸润性乳腺癌进行同时进行免疫组化和荧光原位杂交（FISH）检测的结果，采用 2 种评分系统。
设计
2002 年至 2006 年的病例采用美国食品和药物管理局（FDA）的原始标准进行评分（N=1138），2007 年至 2010 年的病例采用美国临床肿瘤学会/美国病理学家学院（ASCO/CAP）标准进行评分（N=1452）。确定检测方法与临床病理相关性之间的一致性。
结果
9 年间免疫组化/FISH 的总一致性为 96.2%（κ=0.82），阳性一致性较低。2007 年后，HER2/neu 阳性和 HER2/neu 阴性病例的比例用免疫组化检测时没有显著变化（10.5%比 8.9%，P=0.22 和 69.4%比 63%，P=0.13），但不确定病例的数量更高（19.9%比 28%，P<0.001）。2007 年后，FISH 检测的阴性病例比例保持不变（86.5%比 88.2%，P=0.76），但阳性病例的数量较低（13.4%比 9.2%，P<0.001）。此外，38 例（2.6%）FISH 结果不确定，其中 16 例免疫组化结果也不确定。总的来说，2002 年至 2006 年免疫组化/FISH 一致性为 95.9%（κ=0.82），2007 年后为 96.4%（κ=0.82）。然而，在最后一个时期，阳性检测的一致性约低 13%。
结论
应用 ASCO/CAP 推荐的方法与整体免疫组化/FISH 一致性相当，但阳性一致性降低，不确定结果增加。
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