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美国临床肿瘤学会和美国病理医师学会于2010年首次发表乳腺癌雌激素和孕激素受体免疫组织化学检测指南。 2020年1月13日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表美国斯坦福大学、盐湖城山际医疗、美国临床肿瘤学会、北卡罗来纳大学、圣裘德医疗中心、密歇根大学、德克萨斯大学MD安德森癌症中心、安娜堡双子集团、哈佛大学医学院、达纳法伯癌症研究所、耶鲁大学癌症中心、康奈尔大学威尔医学院、缅因癌症医学中心、国家癌症研究所、霍普金斯大学、英国伦敦大学皇家马斯登医院、澳大利亚昆士兰大学、昆士兰病理学中心、加拿大萨斯喀彻温省卫生厅、萨斯喀彻温大学、意大利米兰大学、欧洲肿瘤研究院联合起草的美国临床肿瘤学会和美国病理医师学会乳腺癌雌激素和孕激素受体检测指南更新。 美国临床肿瘤学会和美国病理医师协会召集多学科国际专家组，首先对2008年1月1日～2019年4月30日发表的随机对照研究、系统回顾、荟萃分析、临床实践指南进行检索，随后根据这些医学文献证据对乳腺癌雌激素和孕激素受体检测指南的推荐意见进行更新。 专家组仍然推荐采用已被证实的免疫组织化学方法对乳腺浸润癌进行雌激素受体检测，以此作为预测哪些患者可对内分泌治疗获益的标准，并不推荐采用其他检测方法实现该目的。 雌激素受体阳性的定义：乳腺癌标本的肿瘤细胞核雌激素受体免疫反应染色阳性比例≥1%。 不过，专家组承认，对于肿瘤细胞核雌激素受体免疫反应染色阳性比例仅1%～10%的乳腺癌，内分泌治疗获益的证据极少。 对于肿瘤细胞核雌激素受体免疫反应染色阳性比例仅1%～10%的标本，应该归入新的报告分类：雌激素受体弱阳性，并附推荐意见。 雌激素受体阴性的定义：乳腺癌标本的肿瘤细胞核雌激素受体免疫反应染色阳性比例<1%。 对于雌激素受体免疫反应染色初步结果为弱阳性或阴性的病例，为了提高效率、促进检测结果的解读和报告，推荐增加措施，包括针对实验室具体情况建立标准操作流程，以描述实验室用于确认或判定结果的额外步骤。 对于雌激素受体免疫反应染色阳性比例为0%～10%染色的病例，应该报告对照组的状态。 类似原则适用于孕激素受体检测，主要用于雌激素受体阳性乳腺癌的预后。 推荐对乳腺导管原位癌进行雌激素受体检测，以确定内分泌疗法的可能获益，以减少将来的乳腺浸润癌风险，而对乳腺导管原位癌进行孕激素受体检测则被认为可选项目。 J Clin Oncol. 2020 Jan 13. [Epub ahead of print] Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, Hayes DF, Lakhani SR, Chavez-MacGregor M, Perlmutter J, Perou CM, Regan MM, Rimm DL, Symmans WF, Torlakovic EE, Varella L, Viale G, Weisberg TF, McShane LM, Wolff AC. Stanford University School of Medicine, Stanford, CA; Intermountain Healthcare, Salt Lake City, UT; Royal Marsden Hospital, London, United Kingdom; American Society of Clinical Oncology, Alexandria, VA; University of North Carolina, Chapel Hill, NC; St Jude Medical Center, Fullerton, CA; University of Michigan, Ann Arbor, MI; University of Queensland, Brisbane, Queensland, Australia; Pathology Queensland, Brisbane, Queensland, Australia; MD Anderson Cancer Center, Houston, TX; Gemini Group, Ann Arbor, MI; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Yale Cancer Center, New Haven, CT; Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada; University of Saskatchewan, Saskatoon, Saskatchewan, Canada; Weill Cornell Medicine, New York, NY; European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; University of Milan, Milan, Italy; Maine Center for Cancer Medicine, Scarborough, ME; National Cancer Institute, Rockville, MD; Johns Hopkins University, Baltimore, MD. PURPOSE: To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists estrogen (ER) and progesterone receptor (PgR) testing in breast cancer guideline. METHODS: A multidisciplinary international Expert Panel was convened to update the clinical practice guideline recommendations informed by a systematic review of the medical literature. RECOMMENDATIONS: The Expert Panel continues to recommend ER testing of invasive breast cancers by validated immunohistochemistry as the standard for predicting which patients may benefit from endocrine therapy, and no other assays are recommended for this purpose. Breast cancer samples with 1% to 100% of tumor nuclei positive should be interpreted as ER positive. However, the Expert Panel acknowledges that there are limited data on endocrine therapy benefit for cancers with 1% to 10% of cells staining ER positive. Samples with these results should be reported using a new reporting category, ER Low Positive, with a recommended comment. A sample is considered ER negative if < 1% or 0% of tumor cell nuclei are immunoreactive. Additional strategies recommended to promote optimal performance, interpretation, and reporting of cases with an initial low to no ER staining result include establishing a laboratory-specific standard operating procedure describing additional steps used by the laboratory to confirm/adjudicate results. The status of controls should be reported for cases with 0% to 10% staining. Similar principles apply to PgR testing, which is used primarily for prognostic purposes in the setting of an ER-positive cancer. Testing of ductal carcinoma in situ (DCIS) for ER is recommended to determine potential benefit of endocrine therapies to reduce risk of future breast cancer, while testing DCIS for PgR is considered optional. Additional information can be found at www.asco.org/breast-cancer-guidelines. PMID: 31928404 DOI: 10.1200/JCO.19.02309
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