Krusche C A, von Wasielewski R, Rüschoff J, Fisseler-Eckhoff A, Kreipe H H
Institut für Pathologie, Medizinische Hochschule Hannover, Carl-Neuberg-Strasse 1, 30625, Hannover.
Pathologe. 2008 Jul;29(4):315-20. doi: 10.1007/s00292-008-1004-4.
In the age of personalized medicine, and in addition to typing and grading, breast cancer pathologists are now also involved in determining biomarkers such as steroid hormone receptors and Her-2, which are of the utmost importance in adjuvant therapy. In order to assure quality of these biomarker assays, external proficiency testing has been implemented in Germany. Since 2002 trials have been conducted annually, with up to 180 participating laboratories. More than 85% of all participants achieved good results in clearly negative and positive cases seen in daily practice. If at all, discordant results were observed in the rarer low steroid-hormone receptor expressing tumors and Her-2 borderline cases (2+). Regular participation in interlaboratory testing leads to significantly improved immunohistochemical results, particularly in these problematic cases. Tissue microarrays (TMA) with 20-24 different breast cancer samples including cell lines meant that a huge number of pathologists were challenged with identical samples, providing the prerequisite for comparability. Participation is recommended for pathology departments involved in the service for breast units. The organizational frame work of the trials is described here. The confidence of cooperating disciplines in breast cancer biomarkers assessed by pathologists will be fostered by external proficiency testing as presented here.
在个性化医疗时代，除了进行分型和分级外，乳腺癌病理学家现在还参与确定生物标志物，如类固醇激素受体和Her-2，这些在辅助治疗中至关重要。为确保这些生物标志物检测的质量，德国已开展外部能力验证测试。自2002年起，每年都会进行测试，参与实验室多达180家。在日常实践中，超过85%的参与者在明确的阴性和阳性病例中取得了良好结果。如果有差异结果，通常出现在罕见的低类固醇激素受体表达肿瘤和Her-2临界病例（2+）中。定期参与实验室间测试可显著改善免疫组化结果，尤其是在这些疑难病例中。包含20 - 24种不同乳腺癌样本（包括细胞系）的组织微阵列（TMA）意味着大量病理学家面对相同样本，为可比性提供了前提条件。建议参与乳腺科服务的病理科参加。本文描述了测试的组织架构。正如本文所述，外部能力验证测试将增强合作学科对病理学家评估的乳腺癌生物标志物的信心。
