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：
10.1043/1543-2165-134.6.907
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发表时间：
2010-06
影响因子：
4.6
通讯作者：
M. E. Hammond;Daniel F. Hayes;M. Dowsett;D. C. Allred;K. Hagerty;S. Badve;P. Fitzgibbons;G. Francis
中科院分区：
文献类型：
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作者：
M. E. Hammond;Daniel F. Hayes;M. Dowsett;D. C. Allred;K. Hagerty;S. Badve;P. Fitzgibbons;G. Francis
目的：为提高乳腺癌免疫组织化学（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标志物的应用，制定一项指南。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，多达20%的ER和PgR 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。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。
PURPOSE To 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. METHODS The 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. RESULTS Up 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. RECOMMENDATIONS The 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.