Wang Xinran, He Jiankun, Li Jinze, Wu Chun, Yue Meng, Niu Shuyao, Jia Ying, Jia Zhanli, Cai Lijing, Liu Yueping
Department of Pathology, The Fourth Hospital of Hebei Medical University, No. 12 Jiankang Road, Shijiazhuang, 050011, Hebei, China.
J Cancer Res Clin Oncol. 2024 Jan 28;150(2):43. doi: 10.1007/s00432-023-05595-0.
Given real-world limitations in programmed death-ligand 1 (PD-L1) testing, concordance studies between PD-L1 assays are needed. We undertook comparisons of PD-L1 assays (DAKO22C3, Ventana SP263, Ventana SP142, E1L3N) among observers in esophageal squamous cell carcinoma (ESCC) to provide information on the analytical and clinical comparability of four PD-L1 IHC assays.
Paraffin embedded samples of 50 cases of esophageal squamous cell carcinoma were obtained, satined with all four PD-L1 assays. PD-L1 was evaluated by 68 pathologists from 19 different hospitals. PD-L1 expression was assessed for combined positive score (CPS).
The expression sensitivity of SP263 was the highest in ESCC, followed by 22C3, E1L3N and SP142. Taking CPS 10 as the critical value, inter-observer concordance for CPS scores among 68 physicians was assessed for the 22C3, SP263, SP142, and E1L3N assays, yielding values of 0.777, 0.790, 0.758, and 0.782, respectively. In the comparison between assays, the overall CPS scores concordance rates between 22C3 and SP263, SP142, and E1L3N were 0.896, 0.833, and 0.853, respectively. 22C3 and SP263 have high concordance, with OPA of 0.896, while E1L3N and SP142 have the highest concordance, with OPA of 0.908.
In ESCC, the concordance of PD-L1 evaluation among observers is good, and the immune cell score is still an important factor affecting the concordance of interpretation among observers. Cases near the specific threshold are still the difficult problem of interpretation. SP263 had the highest CPS score of the four assays. SP263 cannot identify all 22C3 positive cases, but had good concordance with 22C3.E1L3N and SP142 showed high concordance.
鉴于程序性死亡配体1（PD-L1）检测在现实世界中的局限性，需要对PD-L1检测方法之间进行一致性研究。我们对食管鳞状细胞癌（ESCC）观察者中的PD-L1检测方法（DAKO22C3、Ventana SP263、Ventana SP142、E1L3N）进行了比较，以提供关于四种PD-L1免疫组化检测方法的分析和临床可比性的信息。
获取50例食管鳞状细胞癌的石蜡包埋样本，用所有四种PD-L1检测方法进行检测。由来自19家不同医院的68名病理学家对PD-L1进行评估。评估PD-L1表达的综合阳性评分（CPS）。
SP263在ESCC中的表达敏感性最高，其次是22C3、E1L3N和SP142。以CPS 10为临界值，对68名医生中22C3、SP263、SP142和E1L3N检测方法的CPS评分观察者间一致性进行评估，分别得出0.777、0.790、0.758和0.782的值。在检测方法之间的比较中，22C3与SP263、SP142和E1L3N之间的总体CPS评分一致性率分别为0.896、0.833和0.853。22C3和SP263具有高度一致性，重叠百分比一致性（OPA）为0.896，而E1L3N和SP142具有最高的一致性，OPA为0.908。
在ESCC中，观察者间PD-L1评估的一致性良好，免疫细胞评分仍是影响观察者间解读一致性的重要因素。接近特定阈值的病例仍是解读的难题。SP263是四种检测方法中CPS评分最高的。SP263不能识别所有22C3阳性病例，但与22C3具有良好的一致性。E1L3N和SP142显示出高度一致性。
