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, Pitsburgh, 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.
Arch Pathol Lab Med. 2014 Feb;138(2):241-56. doi: 10.5858/arpa.2013-0953-SA. Epub 2013 Oct 7.
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.
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.
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.
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.
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，并将其作为浸润性乳腺癌的预测标志物加以利用。
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。
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 HER2 的准确性。该指南已经由这两个组织进行了审查和批准。
更新委员会建议所有浸润性（早期或复发）乳腺癌患者都应根据一项或多项 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，即当（在观察到肿瘤面积的 >10%的连续和同质肿瘤细胞中）存在蛋白过表达（IHC）或基因扩增（HER2 拷贝数或 ISH 基于计数至少 20 个细胞内的区域的 HER2/CEP17 比值）的证据时。如果结果不确定（修订标准），应使用替代检测方法进行反射检测（IHC 或 ISH）。如果结果与其他组织病理学发现不一致，应考虑重复检测。实验室应在足够大且具有代表性的标本集上展示与经过验证的 HER2 检测的高一致性。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卫生系统合作，以确保最高质量的检测。
