刘月平：河北医科大学第四医院（河北省肿瘤医院）病理科主任、病理教研室主任、主任医师、教授、博士生导师、中华医学会病理学分会青年委员会副主任委员、中国老年保健协会病理学工作者委员会副主任委员、中国抗癌协会肿瘤标志专业委员会常务委员、中国研究型医院学会超微与分子病理学专业委员会常务委员、中国老年医学学会病理分会常务委员、河北省抗癌协会肿瘤标志专业委员会主任委员、中华医学会病理学分会乳腺病理学组委员、中国抗癌协会肿瘤病理专业委员会青年委员。
编者按：2018年7月10日，美国临床肿瘤学会《临床肿瘤学杂志》正式发表美国临床肿瘤学会和美国病理学会临床实践指南专项更新：乳腺癌HER2检测。刘月平教授对全文进行翻译如下：
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J Clin Oncol. 2018 Jul 10;36(20):2105-2122.
Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.
Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M.
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore; National Cancer Institute, Bethesda, MD; Intermountain Healthcare and University of Utah School of Medicine, Salt Lake City, UT; Stanford University School of Medicine, Stanford; St Jude Medical Center, Fullerton; University of Southern California, Los Angeles, CA; American Society of Clinical Oncology, Alexandria, VA; Ontario Institute for Cancer Research; Sunnybrook Health Sciences Centre and Women's College Hospital, Toronto, Ontario, Canada; Western Sydney University and Australian Clinical Laboratories, Sydney, New South Wales, Australia; The University of Nottingham, Nottingham; The Royal Marsden NHS Foundation Trust, London, United Kingdom; Mayo Clinic, Rochester, MN; Cancer Information and Support Network, Raleigh, NC; Indiana University School of Medicine, Indianapolis, IN; University of Milan and Istituto Europeo di Oncologia, Milan, Italy.
PURPOSE: To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline.
METHODS: Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations.
RECOMMENDATIONS: Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in > 10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not 'must') be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended work-up for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/chromosome enumeration probe 17 [CEP17] ratio ≥ 2.0; average HER2 copy number < 4.0="" signals="" per="" cell),="" ish="" group="" 3="" (her2/cep17="" ratio="">< 2.0;="" average="" her2="" copy="" number="" ≥="" 6.0="" signals="" per="" cell),="" and="" ish="" group="" 4="" (her2/cep17="" ratio="">< 2.0;="" average="" her2="" copy="" number="" ≥="" 4.0="" and="">< 6.0="" signals="" per="" cell).="" the="" diagnostic="" approach="" includes="" more="" rigorous="" interpretation="" criteria="" for="" ish="" and="" requires="" concomitant="" ihc="" review="" for="" dual-probe="" ish="" groups="" 2="" to="" 4="" to="" arrive="" at="" the="" most="" accurate="" her2="" status="" designation="" (positive="" or="" negative)="" based="" on="" combined="" interpretation="" of="" the="" ish="" and="" ihc="" assays.="" the="" expert="" panel="" recommends="" that="" laboratories="" using="" single-probe="" ish="" assays="" include="" concomitant="" ihc="" review="" as="" part="" of="" the="" interpretation="" of="" all="" single-probe="" ish="" assay="">
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