Antonio C. Wolff, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore; Lisa M. McShane, National Cancer Institute, Bethesda, MD; M. Elizabeth H. Hammond, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City, UT; David G. Hicks, University of Rochester Medical Center, Rochester, NY; Mitch Dowsett, Royal Marsden Hospital, London, United Kingdom; Kimberly H. Allison, Stanford University Medical Center, Stanford; Patrick Fitzgibbons, St Jude Medical Center, Fullerton; Michael F. Press, University of Southern California, Los Angeles, CA; Donald C. Allred, Washington University School of Medicine, St Louis, MO; John M.S. Bartlett, Ontario Institute for Cancer Research; Wedad Hanna, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Michael Bilous, University of Western Sydney and Healthscope Pathology, Sydney, New South Wales, Australia; Robert B. Jenkins, Mayo Clinic, Rochester, MN; Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, VA; Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Patricia A. Spears, North Carolina State University, Raleigh, NC; Gail H. Vance, Indiana University Medical Center, Indianapolis, IN; Giuseppe Viale, University of Milan, European Institute of Oncology, Milan, Italy; and Daniel F. Hayes, University of Michigan Comprehensive Cancer Care Center, Ann Arbor, MI.
J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.
PURPOSE: To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. METHODS: ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. RESULTS: The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. RECOMMENDATIONS: The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to > 10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing. This guideline was developed through a collaboration between the American Society of Clinical Oncology and the College of American Pathologists and has been published jointly by invitation and consent in both Journal of Clinical Oncology and the Archives of Pathology & Laboratory Medicine.
目的：更新美国临床肿瘤学会（ASCO）/美国病理学家协会（CAP）关于乳腺癌人表皮生长因子受体 2（HER2）检测的指南建议，以提高 HER2 检测的准确性及其作为浸润性乳腺癌预测标志物的实用性。
方法：ASCO/CAP 召集了一个更新委员会，其中包括 2007 年指南的共同作者，以进行系统的文献回顾并更新最佳 HER2 检测建议。
结果：更新委员会确定了需要澄清的标准和领域，以提高免疫组织化学（IHC）或原位杂交（ISH）检测的 HER2 检测的准确性。该指南已经由两个组织进行了审查和批准。
建议：更新委员会建议在所有浸润性（早期或复发）乳腺癌患者中，根据一项或多项 HER2 检测结果（阴性、不确定或阳性）确定 HER2 状态（HER2 阴性或阳性）。检测标准定义了 HER2 阳性状态，当（在肿瘤面积中观察到> 10%的连续和同质肿瘤细胞）存在蛋白过表达（IHC）或基因扩增（HER2 拷贝数或 HER2/CEP17 比值通过 ISH 计数面积内至少 20 个细胞）时。如果结果不确定（修订标准），应使用替代检测方法（IHC 或 ISH）进行反射性检测。如果结果与其他组织病理学发现不一致，应考虑重复检测。实验室应在足够大和具有代表性的标本上，展示与经验证的 HER2 检测具有高度一致性。检测必须在经过 CAP 或其他认证实体认证的实验室中进行。更新委员会敦促提供者和医疗系统合作，以确保最高质量的检测。本指南是由美国临床肿瘤学会与美国病理学家协会合作制定的，并由 Journal of Clinical Oncology 和 Archives of Pathology & Laboratory Medicine 联合邀请和同意共同发表。
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