American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer
American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer
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DOI：
10.1200/jco.2009.25.6529
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发表时间：
2010-06-01
影响因子：
45.3
通讯作者：
Wolff, Antonio C.
中科院分区：
文献类型：
--
作者：
Hammond, M. Elizabeth H.;Hayes, Daniel F.;Wolff, Antonio C.
目的探讨提高乳腺癌免疫组化（IHC）雌激素受体（ER）和孕激素受体（PgR）检测的准确性，以及这些受体作为预测指标的应用价值。方法美国临床肿瘤学会和美国病理学家学会召集了一个国际专家小组，与安大略省癌症护理中心合作，对文献进行了系统的回顾和评估，并提出了最佳IHC ER/PgR检测性能的建议。结果目前全球范围内的ER和PgR检测中，高达20%的IHC检测结果可能不准确（假阴性或假阳性）。大多数测试问题都是由于分析前变量、阳性阈值和解释标准的变化而发生的。建议专家小组建议对所有浸润性乳腺癌和乳腺癌复发进行ER和PgR检测。提出了一种依赖于准确、可重复分析性能的测试算法。指定了可靠地减少测定变化的元素。如果在预期的内部（正常上皮细胞）和外部对照存在反应性的情况下，样品中至少有1%的肿瘤核呈阳性，则建议将ER和PgR检测视为阳性。大量随机临床试验的综述证实，内分泌治疗对er阴性侵袭性乳腺癌患者没有益处。该指南由美国临床肿瘤学会和美国病理学家学会合作制定，并经邀请和同意在《临床肿瘤杂志》和《病理与实验室医学档案》上联合发表。版权所有(C) 2010美国临床肿瘤学会和美国病理学家学院。版权所有。未经美国临床肿瘤学会或美国病理学家学会的书面许可，不得以任何形式或任何电子或机械方式（包括影印、录音或任何信息存储和检索系统）复制或传播本文件的任何部分。
PurposeTo develop a guideline to improve the accuracy of immunohistochemical (IHC) estrogen receptor ( ER) and progesterone receptor (PgR) testing in breast cancer and the utility of these receptors as predictive markers.MethodsThe American Society of Clinical Oncology and the College of American Pathologists convened an international Expert Panel that conducted a systematic review and evaluation of the literature in partnership with Cancer Care Ontario and developed recommendations for optimal IHC ER/PgR testing performance.ResultsUp to 20% of current IHC determinations of ER and PgR testing worldwide may be inaccurate ( false negative or false positive). Most of the issues with testing have occurred because of variation in preanalytic variables, thresholds for positivity, and interpretation criteria.RecommendationsThe Panel recommends that ER and PgR status be determined on all invasive breast cancers and breast cancer recurrences. A testing algorithm that relies on accurate, reproducible assay performance is proposed. Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal ( normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials.This guideline was developed through a collaboration between American Society of Clinical Oncology and College of American Pathologists and has been published jointly by invitation and consent in both the Journal of Clinical Oncology and the Archives of Pathology & Laboratory Medicine. Copyright (C) 2010 American Society of Clinical Oncology and College of American Pathologists. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without written permission by American Society of Clinical Oncology or College of American Pathologists.