CT 引导下经胸穿刺活检评估 PD-L1 表达：22C3 与 SP263 检测方法的比较。
CT-guided transthoracic needle biopsy for evaluation of PD-L1 expression: Comparison of 22C3 and SP263 assays.
机构信息
Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Division of Pulmonology, Department of Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
出版信息
Thorac Cancer. 2019 Jul;10(7):1612-1618. doi: 10.1111/1759-7714.13126. Epub 2019 Jun 24.
BACKGROUND
Although there have been several studies on concordance of different assays testing programmed cell death ligand-1 (PD-L1) expression using surgical specimens, studies using real-world biopsy specimens are scarce. However, many of the non-small cell lung cancer (NSCLC) cases requiring immunotherapy and thus PD-L1 testing are unresectable having to rely on small biopsy results. Therefore, we sought to assess the concordance of two diagnostic assays (22C3 and SP263) in evaluating PD-L1 expression using specimens from CT-guided transthoracic needle biopsy (TNB) specimens in a routine clinical setting.
METHODS
A total of 202 NSCLC cases that underwent CT-guided TNB from April 2017 to February 2018 were retrospectively reviewed. Biopsy specimens tested with both 22C3 and SP263 assays were included. Concordance of PD-L1 expression levels determined by two assays was assessed using intraclass correlation coefficient, and the agreement of dichotomized values at various cutoffs (1%, 25%, and 50%) were assessed using Cohen's κ coefficient of agreement.
RESULTS
A total of 80 patients (M:F = 47:33, mean age: 68.0 years) were included in the study. Concordance of PD-L1 expression levels was high (intraclass coefficient: 0.892) between 22C3 and SP263 assays. Agreements at cutoff levels of 1%, 25%, and 50% were also good, with κ values of 0.878, 0.698, and 0.790, respectively. Positive percent agreement was 93.2%, 100.0%, and 95.2% for agreements at 1%, 25%, and 50%.
CONCLUSION
There is a high concordance of PD-L1 expression evaluated with 22C3 and SP263 assays using CT-guided TNB specimens.
背景
虽然已经有几项研究探讨了使用手术标本检测程序性细胞死亡配体-1（PD-L1）表达的不同检测方法的一致性，但使用真实活检标本的研究却很少。然而，许多需要免疫治疗和 PD-L1 检测的非小细胞肺癌（NSCLC）病例都是不可切除的，只能依靠小活检结果。因此，我们试图评估两种诊断检测方法（22C3 和 SP263）在评估 CT 引导下经胸穿刺活检（TNB）标本中 PD-L1 表达的一致性，这些标本是在常规临床环境下获得的。
方法
回顾性分析了 2017 年 4 月至 2018 年 2 月期间接受 CT 引导下 TNB 的 202 例 NSCLC 病例。包括用 22C3 和 SP263 检测的活检标本。使用组内相关系数评估两种检测方法确定的 PD-L1 表达水平的一致性，并使用 Cohen's κ 系数评估不同截断值（1%、25%和 50%）的二分值的一致性。
结果
共纳入 80 例患者（男：女=47：33，平均年龄：68.0 岁）。22C3 和 SP263 检测方法之间 PD-L1 表达水平的一致性很高（组内系数：0.892）。在 1%、25%和 50%的截断值水平上的一致性也很好，κ 值分别为 0.878、0.698 和 0.790。对于 1%、25%和 50%的一致性，阳性百分率分别为 93.2%、100.0%和 95.2%。
结论
使用 CT 引导 TNB 标本评估 22C3 和 SP263 检测方法时，PD-L1 表达具有高度一致性。
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