OBJECTIVES The main objective was to investigate the relationship between Programmed cell Death-ligand 1 (PD-L1) expression levels and the frequency of primary resistance to Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) in treatment naïve advanced EGFR-mutant lung adenocarcinoma patients. MATERIALS AND METHODS From 2012-2017, we enrolled advanced EGFR-mutant lung adenocarcinoma patients who displayed primary resistance to EGFR-TKI therapy, along with patients with disease control, and patients experiencing either stable disease or partial response to EGFR-TKI treatment. RESULTS Sixty-six patients were enrolled as the primary resistance group, while 57 patients were included as the disease control group. Fifteen-five (22.7%) patients had a PD-L1 Tumor Proportion Score (TPS) ≧50% in the primary resistance group, with only one patient (1.8%) having that score in the disease control group (P＜0.001). Twenty (30.3%) patients had a PD-L1 ≧25% in the primary resistance group, with 2 (3.5%) patients having that level in the disease control group (P＜0.001). Thirty (45.5%) patients had a PD-L1 ≧1% in the primary resistance group, with 7 (12.3%) patients at that level in the disease control group (P = 0.001). Patients with a PD-L1≧1% displayed a higher incidence of primary resistance to EGFR-TKIs than those with a PD-L1＜1% (Odds Ratio (OR), 5.95; 95% Confidence Interval (CI), 2.35-15.05; P＜0.001). The phenomenon existed still when the cutoff value was changed to both 25% (OR, 11.96; 95% CI, 2.65-53.87; P = 0.001) and 50% (OR, 16.47; 95% CI, 2.10-129.16; P = 0.008). The estimated median Progression-free Survival (PFS) rate was 7.3 months in patients with a PD-L1＜1%, 2.1 months in patients with a PD-L1≧1%, 1.8 months in patients with a PD-L1≧25%, and 1.6 months in patients with a PD-L1≧50%. CONCLUSIONS Treatment for advanced EGFR-mutant lung adenocarcinoma patients displaying a higher PD-L1 expression level experienced a higher frequency of primary resistance to EGFR-TKIs.

中文翻译：

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PD-L1的高表达与未治疗过的EGFR突变的肺腺癌患者对EGFR-TKIs的原发耐药有关。

目的主要目的是研究未经治疗的晚期EGFR-PD中程序性细胞死亡配体1（PD-L1）表达水平与对表皮生长因子受体（EGFR）-酪氨酸激酶抑制剂（TKI）的原发耐药频率之间的关系。突变型肺腺癌患者。材料与方法从2012年至2017年，我们招募了对EGFR-TKI治疗表现出主要耐药性的晚期EGFR突变型肺腺癌患者，以及患有疾病控制的患者，以及对EGFR-TKI治疗表现出稳定疾病或部分反应的患者。结果66例患者被纳入原发性耐药组，而57例患者被纳入疾病控制组。在主要抵抗力组中，有15例（22.7％）患者的PD-L1肿瘤比例评分（TPS）≥50％，在疾病对照组中只有一名患者（1.8％）具有该评分（P ＜0.001）。在原发性耐药组中有20名（30.3％）患者的PD-L1≥25％，在疾病对照组中有2名（3.5％）患者的PD-L1≥25％（P ＜0.001）。在原发性耐药组中有30名（45.5％）患者的PD-L1≥1％，在疾病对照组中有7名（12.3％）患者达到该水平（P = 0.001）。与PD-L1 ＜1％的患者相比，PD-L1≥1％的患者对EGFR-TKIs的原发耐药率更高（几率（OR）为5.95； 95％可信区间（CI）为2.35-15.05） ； P ＜0.001）。当临界值更改为25％（OR，11.96; 95％CI，2.65-53.87; P = 0.001）和50％（OR，16.47; 95％CI，2.10-129.16; P = 0.008）时，仍然存在该现象。 ）。PD-L1 ＜1％的患者的估计中位无进展生存期（PFS）为7.3个月，PD-L1≥1％的患者为2.1个月，PD-L1≥25％的患者为1.8个月，PD-L1≥50％的患者为1.6个月。结论显示较高PD-L1表达水平的晚期EGFR突变肺腺癌患者的治疗对EGFR-TKIs的原发耐药率较高。