The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically evaluate the ability of the level of HER2 expression or gene amplification in breast cancer tumors to serve as a prognostic and a predictive factor in the metastatic and adjuvant settings, to assess the reliability of the methods of measuring HER2 expression or gene amplification in the laboratory, and to make recommendations regarding the interpretation of test results. The Task Force is a multidisciplinary panel of 24 experts in breast cancer representing the disciplines of medical oncology, pathology, radiation oncology, surgical oncology, epidemiology, and patient advocacy. Invited members included members of the NCCN Breast Cancer Panel and other needed experts selected solely by the NCCN. During a 2-day meeting, individual task force members provided didactic presentations critically evaluating important aspects of HER2 biology and epidemiology: HER2 as a prognostic and predictive factor; results from clinical trials in which trastuzumab was used as a targeted therapy against HER2 in the adjuvant and metastatic settings; the available testing methodologies for HER2, including sensitivity, specificity, and ability to provide prognostic and predictive information; and the principles on which HER2 testing should be based. Each task force member was charged with identifying evidence relevant to their specific expertise and presentation. Following the presentations, an evidence-based consensus approach was used to formulate recommendations relating to the pathologic and clinical application of the evidence to breast cancer patient evaluation and care. In areas of controversy, this process extended beyond the meeting to achieve consensus. The Task Force concluded that accurate assignment of the HER2 status of invasive breast cancer is essential to clinical decision making in the treatment of breast cancer in both adjuvant and metastatic settings. Formal validation and concordance testing should be performed and reported by laboratories performing HER2 testing for clinical purposes. If appropriate quality control/assurance procedures are in place, either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods may be used. A tumor with an IHC score of 0 or 1+, an average HER2 gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or greater is considered HER2 positive. A tumor with an IHC score of 2+ should be further tested using FISH, with HER2 status determined by the FISH result. Tumor samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are considered to be borderline, and strategies to assign the HER2 status of such samples are proposed.

译文

乳腺癌工作组的NCCN HER2测试是为了严格评估乳腺癌肿瘤中HER2表达或基因扩增水平在转移和辅助环境中作为预后和预测因素的能力,评估实验室中测量HER2表达或基因扩增方法的可靠性,并就测试结果的解释提出建议。该工作组是由24位乳腺癌专家组成的多学科小组,代表医学肿瘤学,病理学,放射肿瘤学,外科肿瘤学,流行病学和患者倡导等学科。受邀成员包括NCCN乳腺癌小组的成员以及NCCN单独挑选的其他所需专家。在为期2天的会议中,个别工作组成员提供了教学报告,批判性地评估了HER2生物学和流行病学的重要方面: HER2作为预后和预测因素; 曲妥珠单抗在辅助和转移环境中被用作针对HER2的靶向治疗的临床试验结果; HER2可用的测试方法,包括敏感性,特异性以及提供预后和预测信息的能力; 以及HER2测试应基于的原则。每个工作队成员都负责确定与其特定专业知识和陈述相关的证据。演讲结束后,使用基于证据的共识方法来制定有关证据在乳腺癌患者评估和护理中的病理和临床应用的建议。在有争议的领域,这一进程超出了会议的范围,以达成共识。工作组得出结论,准确分配浸润性乳腺癌的HER2状态对于辅助和转移性乳腺癌治疗的临床决策至关重要。正式验证和一致性测试应由进行HER2测试的实验室进行并报告,以用于临床目的。如果有适当的质量控制/保证程序,则可以使用免疫组织化学 (IHC) 或荧光原位杂交 (FISH) 方法。IHC评分为0或1 + 、平均HER2基因/染色体17比率小于1.8、或平均HER2基因拷贝数/细胞数为4或更少 (由FISH测定) 的肿瘤被认为是HER2阴性。IHC评分为3 + 、FISH平均HER2基因/17号染色体比率大于2.2或HER2基因拷贝/细胞平均数为6或更大的肿瘤被认为是HER2阳性。IHC评分为2 + 的肿瘤应使用FISH进一步检测,HER2状态由FISH结果确定。具有1.8至2.2的平均HER2基因/染色体比率或HER2基因拷贝/细胞的平均数在大于4至小于6的范围内的肿瘤样品被认为是临界的,并且提出了分配此类样品的HER2状态的策略。

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