The efficacy of immune checkpoint inhibitor (ICI) therapy concerning programmed death ligand 1 (PD-L1) status is well established in patients diagnosed with non-small cell lung cancer (NSCLC). However, there remains a paucity of evidence regarding the efficacy concerning tumor mutational burden (TMB) in both clinical trials and real-world data (RWD). In the current article, clinicopathological and molecular epidemiological data were meticulously collected, and treatment modalities were meticulously recorded. The final analysis included a study population of 194 patients. Median age was 67 years (range 37–86), with the majority being male (71.13%), and 85.71% of patients were either current or former smokers at diagnosis. Adenocarcinoma accounted for most diagnoses (71.65%), followed by squamous cell carcinoma (24.23%). In terms of PD-L1 status, 42.78% had an expression level below 1%, 28.35% had an expression between 1–49%, and 28.87% had an expression above 50%. The TMB ranged from 0 to 75, with a median of 10.31 (range 0–75) for PD-L1 expression below 1%, with a median of 9.73 (range 0.95–39.63) for PD-L1 expression between 1–49%, and a median of 9.72 (range 0.95–48) for PD-L1 expression above 50%. Corresponding to patients with low PDL-1 less than 1% and low TMB (0–5), the median overall survival (mOS) was 16 (p= 0.18), and 15 months (p= 0.22), patients with medium PDL-1 (1–49%) and medium TMB (5–10), the mOS was 15 (p= 0.18) and 16 months (p= 0.22), patients with high PDL-1 (>50) and high TMB (>10), the mOS was 24 (p= 0.18) and 21 (p= 0.22) months. This study represents the largest academic RWD dataset concerning PD-L1 and TMB status in patients with locally advanced and metastatic NSCLC.
免疫检查点抑制剂（ICI）疗法在程序性死亡配体1（PD-L1）表达状态不同的非小细胞肺癌（NSCLC）患者中的疗效已得到充分证实。然而，关于肿瘤突变负荷（TMB）疗效的临床研究及真实世界数据（RWD）证据仍显不足。本研究系统收集了患者的临床病理学与分子流行病学数据，并详细记录了治疗方案。最终分析共纳入194例患者，中位年龄67岁（范围37-86岁），男性占71.13%，确诊时当前或既往吸烟者达85.71%。组织学类型以腺癌为主（71.65%），其次为鳞状细胞癌（24.23%）。PD-L1表达水平方面，42.78%患者表达低于1%，28.35%表达介于1-49%，28.87%表达高于50%。TMB分布范围为0-75，其中PD-L1表达<1%组中位TMB为10.31（范围0-75），PD-L1表达1-49%组中位TMB为9.73（范围0.95-39.63），PD-L1表达≥50%组中位TMB为9.72（范围0.95-48）。生存分析显示：PD-L1低表达（<1%）且TMB低水平（0-5）患者中位总生存期（mOS）为16个月（p=0.18），PD-L1中等表达（1-49%）且TMB中等水平（5-10）患者mOS为15个月（p=0.18），PD-L1高表达（≥50%）且TMB高水平（>10）患者mOS达24个月（p=0.18）。本研究构建了目前关于局部晚期及转移性NSCLC患者PD-L1与TMB状态的最大规模学术性真实世界数据集。
肿瘤(癌症)患者之家