Lacroix-Triki Magali, Mathoulin-Pelissier Simone, Ghnassia Jean-Pierre, Macgrogan Gaetan, Vincent-Salomon Anne, Brouste Véronique, Mathieu Marie-Christine, Roger Pascal, Bibeau Frédéric, Jacquemier Jocelyne, Penault-Llorca Frédérique, Arnould Laurent
Department of Pathology, Institut Claudius Regaud, 20-24 rue du pont Saint Pierre, 31052 Toulouse Cedex, France.
Eur J Cancer. 2006 Nov;42(17):2946-53. doi: 10.1016/j.ejca.2006.06.020. Epub 2006 Sep 20.
The accurate determination of HER-2 in invasive breast cancer has become a critical issue, particularly in the context of the results of recent trastuzumab (Herceptin((R))) adjuvant trials. This multicentre study evaluated inter-observer reproducibility in interpretation of HER-2 immunostains performed in different laboratories according to their in-house technique. A total of 74 HER-2 immunostains were evaluated by 16 pathologists and by a central review committee. As determined by central review, the HER-2 score was 0 in 33 cases (44%), 1+ in 10 cases (13%), 2+ in 9 cases (12%) and 3+ in 23 cases (31%). The overall kappa value was good (kappa=0.75). Agreement was excellent for the 0/1+ group (kappa=0.85) and for the 3+ group (kappa=0.82). As expected, the score 2+ group showed poor agreement (kappa=0.38). A quality assurance process showed that ring studies and adherence to national guidelines greatly improve inter-observer reproducibility.
浸润性乳腺癌中HER-2的准确检测已成为一个关键问题，特别是在近期曲妥珠单抗（赫赛汀）辅助治疗试验结果的背景下。这项多中心研究根据不同实验室的内部技术，评估了HER-2免疫染色解读中的观察者间可重复性。16名病理学家和一个中央审查委员会对总共74例HER-2免疫染色进行了评估。经中央审查确定，HER-2评分在33例（44%）中为0，10例（13%）中为1+，9例（12%）中为2+，23例（31%）中为3+。总体kappa值良好（kappa=0.75）。0/1+组（kappa=0.85）和3+组（kappa=0.82）的一致性极佳。正如预期的那样，2+评分组的一致性较差（kappa=0.38）。质量保证过程表明，环形研究和遵循国家指南可大大提高观察者间的可重复性。
