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Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany.

乳腺癌HER2检测质量评估:德国一项大规模多中心观察性研究中影响HER2阳性率的因素

Rüschoff J,Lebeau A,Kreipe H,Sinn P,Gerharz CD,Koch W,Morris S,Ammann J,Untch M,
阅读:1049 Modern PathologyFeb 2017; 30 (2): 158 - 313:217-226 

Abstract

Despite >10 years of routine human epidermal growth factor receptor 2 (HER2) testing in breast cancer, testing quality is still an issue. Guidelines recommend assessing HER2 positivity rates as a quality indicator; however, the extent to which patient- or tumor-related factors influence HER2 positivity is still unknown. The present study analyzed these influences to identify pathology centers with HER2 positivity rates unexplained by patient- or tumor-related factors. This observational, prospective study monitored routine HER2 testing at 57 institutes of pathology in Germany (January 2013-August 2014). Data collected included HER2 test result, patient- and tumor-related factors, sample source, and method of sample retrieval. Factors influencing HER2 positivity rates were identified by multiple logistic regression. Individual center effects were assessed in an extended multiple logistic regression model by their statistical significance after adjusting for the combined effect of patient- or tumor-related covariates and multiple testing. Analyses included 15 332 invasive breast cancer samples. Histologic grade showed the strongest influence on HER2 positivity, followed by hormone receptor status, histologic subtype, age, and nodal status (all P<0.0001). The overall HER2 positivity rate across centers was 14.4% (range 7.1-27.3%). A statistically significant center effect on the HER2 positivity rate was identified for three centers (P<0.05), with a trend toward a center effect for a further three (P<0.2). This study, the first of its kind, highlights that assessing HER2 testing quality with HER2 positivity rates should include standardized assessment of patient- or tumor-related characteristics to identify centers with HER2 testing quality issues more effectively. As treatment options for HER2-positive breast cancer continue to evolve, identifying the right patients is key.

摘要

尽管乳腺癌HER2常规检测已经进行了10年以上,可是检测质量仍然存在问题。各种指南均建议将评价HER2阳性率作为质量指标,然而,病人或肿瘤相关的因素对HER2阳性的影响程度尚未可知。这项研究分析了这些影响因素,以找出那些HER2阳性率不能用患者或肿瘤相关因素解释的病理中心。这项前瞻性观察研究监测了德国57所病理机构的常规HER2检测(2013年1月-2014年8月)。收集的数据包括HER2检测结果,患者和肿瘤相关因素,样本来源,取回样本的方法。影响HER2阳性率的因素通过多元逻辑回归进行识别。通过调整多元逻辑回归模型,适应病人或肿瘤相关协从变量的综合效应,利用扩展了的多元逻辑回归模型并多次检测,根据它们的统计学意义,对每家机构的中心效应进行评价。分析包括15332个侵入性的乳腺癌样本。组织学评分对HER2阳性的影响最强,其次是激素受体状况,组织学亚型,年龄,淋巴结情况(全部P<0.0001)。各中心总体的HER2阳性率是14.4%(变化范围7.1-27.3%)。3家机构对HER2阳性率的中心效应有显著的统计学意义(P<0.05),另有3家有产生中心效应的趋势(P<0.02)。本研究是同类研究中的首例,强调用HER2阳性率评价HER2检测质量时应当包括对病人或肿瘤相关因素的标准化评价,以更有效的辨别出有HER2检测质量问题的机构。随着HER2阳性乳腺癌的治疗方法不断进步,正确的识别病人成了关键。

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