Yang Xin, Jiang Lili, Jin Yan, Li Peng, Hou Yingyong, Yun Jingping, Wu Chunyan, Sun Wenyong, Fan Xiangshan, Kuang Dong, Wang Weiya, Ni Jinsong, Mao Anhua, Tang Wenmin, Liu Zhenhua, Wang Jiali, Xiao Suijun, Li Yuan, Lin Dongmei
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Pathology, Peking University Cancer Hospital & Institute, Beijing, China.
Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
J Cancer. 2021 Oct 28;12(24):7390-7398. doi: 10.7150/jca.63003. eCollection 2021.
This study aimed to investigate the prevalence of tumor programmed death-ligand 1 (PD-L1) expression in Chinese patients with advanced Non-Small Cell Lung Cancer (NSCLC). Tumor tissues with histologically confirmed stage IIIB/IV NSCLC were retrospectively obtained from 10 centers in China. PD-L1 expression was determined using the PD-L1 IHC 22C3 pharmDx kit (Agilent, Santa Clara, CA, USA) and the samples were repetitively assayed with the PD-L1 IHC 22C3 Ab concentrate (Agilent, Santa Clara, CA, USA). Out of 901 patients who met the inclusion criteria, 879 (97.6%) had evaluable PD-L1 data. The number of patients with a PD-L1 tumor proportion score (TPS) < 1%, 1-49%, and ≥ 50% (corresponding to PD-L1 non-expression, low expression, and high expression) was 424 (48.2%), 266 (30.3%), and 189 (21.5%), respectively. PD-L1 expression was more likely to be found in patients younger than 75 years, men, current or former smokers, those with good performance status (PS) scores, and those with a wild-type epidermal growth factor receptor (EGFR). PD-L1 TPS ≥ 50% and ≥ 1% were respectively 28.0% and 50.2% among patients negative for both EGFR mutation and anaplastic lymphoma kinase (ALK) rearrangement. PD-L1 expression determined using the 22C3 antibody concentrate and pharmDx kit had comparable results. The prevalence of PD‑L1 expression in advanced NSCLC was consistent with that reported in the global EXPRESS study. Age, gender, smoking history, PS scores, and EGFR/ALK mutation status affected PD-L1 expression. The 22C3 antibody concentrate appears to be an alternative reagent for the PD-L1 assay.
本研究旨在调查中国晚期非小细胞肺癌（NSCLC）患者肿瘤程序性死亡配体1（PD-L1）的表达情况。从中国10个中心回顾性获取组织学确诊为IIIB/IV期NSCLC的肿瘤组织。使用PD-L1免疫组化22C3检测试剂盒（美国加利福尼亚州圣克拉拉市安捷伦公司）测定PD-L1表达，并使用PD-L1免疫组化22C3抗体浓缩液（美国加利福尼亚州圣克拉拉市安捷伦公司）对样本进行重复检测。在901例符合纳入标准的患者中，879例（97.6%）有可评估的PD-L1数据。PD-L1肿瘤比例评分（TPS）<1%、1%-49%和≥50%（分别对应PD-L1无表达、低表达和高表达）的患者数量分别为424例（48.2%）、266例（30.3%）和189例（21.5%）。PD-L1表达更常见于年龄小于75岁的患者、男性、当前或既往吸烟者、体能状态（PS）评分良好的患者以及具有野生型表皮生长因子受体（EGFR）的患者。在EGFR突变和间变性淋巴瘤激酶（ALK）重排均为阴性的患者中，PD-L1 TPS≥50%和≥1%的比例分别为28.0%和50.2%。使用22C3抗体浓缩液和检测试剂盒测定的PD-L1表达结果具有可比性。晚期NSCLC中PD-L1表达情况与全球EXPRESS研究报告的一致。年龄、性别、吸烟史、PS评分以及EGFR/ALK突变状态影响PD-L1表达。22C3抗体浓缩液似乎是PD-L1检测的一种替代试剂。
