Terrenato Irene, Arena Vincenzo, Pizzamiglio Sara, Pennacchia Ilaria, Perracchio Letizia, Buglioni Simonetta, Ercolani Cristiana, Sperati Francesca, Costarelli Leopoldo, Bonanno Elena, Baldini Daniela, Candia Silvia, Crescenzi Anna, Dal Mas Antonella, Di Cristofano Claudio, Gomes Vito, Grillo Lucia Rosalba, Pasquini Paola, Pericoli Maria Nicoletta, Ramieri Maria Teresa, Di Stefano Domenica, Ruco Luigi, Scarpino Stefania, Vitolo Domenico, d'Amati Giulia, Paradiso Angelo, Verderio Paolo, Mottolese Marcella
Pathology Department, Regina Elena National Cancer Institute, Via Elio Chianesi 53, Rome, 00144, Italy.
J Exp Clin Cancer Res. 2013 Aug 21;32(1):58. doi: 10.1186/1756-9966-32-58.
An External Quality Assessment (EQA) program was developed to investigate the state of the art of HER2 immunohistochemical determination in breast cancer (BC) in 16 Pathology Departments in the Lazio Region (Italy). This program was implemented through two specific steps to evaluate HER2 staining (step 1) and interpretation (step 2) reproducibility among participants.
The management activities of this EQA program were assigned to the Coordinating Center (CC), the Revising Centers (RCs) and the Participating Centers (PCs). In step 1, 4 BC sections, selected by RCs, were stained by each PC using their own procedures. In step 2, each PC interpreted HER2 score in 10 BC sections stained by the CC. The concordance pattern was evaluated by using the kappa category-specific statistic and/or the weighted kappa statistic with the corresponding 95% Jackknife confidence interval.
In step 1, a substantial/almost perfect agreement was reached between the PCs for scores 0 and 3+ whereas a moderate and fair agreement was observed for scores 1+ and 2+, respectively.In step 2, a fully satisfactory agreement was observed for 6 out of the 16 PCs and a quite satisfactory agreement was obtained for the remaining 10 PCs.
Our findings highlight that in the whole HER2 evaluation process the two intermediate categories, scores 1+ and 2+, are less reproducible than scores 0 and 3+. These findings are relevant in clinical practice where the choice of treatment is based on HER2 positivity, suggesting the need to share evaluation procedures within laboratories and implement educational programs.
开展了一项外部质量评估（EQA）计划，以调查意大利拉齐奥地区16个病理科乳腺癌（BC）中HER2免疫组织化学检测的技术水平。该计划通过两个特定步骤实施，以评估参与者之间HER2染色（步骤1）和判读（步骤2）的可重复性。
该EQA计划的管理活动分配给协调中心（CC）、审核中心（RCs）和参与中心（PCs）。在步骤1中，由审核中心挑选的4个BC切片由每个参与中心使用各自的程序进行染色。在步骤2中，每个参与中心对由协调中心染色的10个BC切片的HER2评分进行判读。通过使用kappa类别特异性统计量和/或加权kappa统计量以及相应的95%刀切法置信区间来评估一致性模式。
在步骤1中，参与中心之间对于0分和3+分达成了实质性/几乎完美的一致性，而对于1+分和2+分分别观察到中等和一般的一致性。在步骤2中，16个参与中心中有6个观察到完全令人满意的一致性，其余10个参与中心获得了相当令人满意的一致性。
我们的研究结果表明，在整个HER2评估过程中，两个中间类别，即1+分和2+分，比0分和3+分的可重复性更低。这些结果在基于HER2阳性选择治疗的临床实践中具有相关性，表明需要在各实验室之间共享评估程序并实施教育计划。
