--本文经《美国外科病理学杂志》授权发布，其他媒体转载或引用须经《美国外科病理学杂志》同意，否则追究法律责任。
 

　　帕姆单抗是治疗非小细胞肺癌唯一一种程序性细胞死亡1/程序性死亡配体1(programmed cell death 1/programmed death-ligand i1，PD-1/PD-L1)抑制剂，为伴随22C3PharmDx诊断分析的抑制剂。尽管在许多研究中，22C3和Ventana的SP263似乎产生了重叠的结果，但它们在临床临界值（1%和50%)上存在差异。考虑到在临床实践中由于使用的不同克隆号抗体之间经过训练的病理学家间的差异，我们在一个大的非小细胞肺癌病例队列中提供了22C3和SP263分析的可靠比较。根据制造商的说明，在Dako Link-48平台上对22C3和Ventana Benchmark Ultra平台上对SP263进行了198例肺切除标本组织微阵列序列切片的染色，还制定了在Ventana平台上运行22C3抗体的方案。病理学家对于22C3抗体在1%和50%临界值的判读结果均高于SP263的判读结果。对于各自平台上使用的的22C3和SP263抗体，我们发现，在两个临界值的阳性病例比例存在显著的统计学差异；在50%临界值，大约一半的SP263阳性病例被2位病理医生定义为22C3阴性。当22C3和SP263两种抗体均在Ventana平台上运行时，也观察到了显著的差异。在两个平台上同时进行22C3抗体染色则差异最小。通过22C3和SP263的分析显示，由于在PD-L1阳性病例的临界值判断中出现差异，导致可能适用于帕姆单抗治疗患者的遗漏。

Am J Surg Pathol 2018;42:1384—1389

美国外科病理学杂志中文版2019年第二期摘要NO.3

(刘月平 翻译/审校）

　　©2018 Wolters Kluwer Health

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