Background:A prognostic marker in patients with non-small-cell lung cancer (NSCLC) treated with anti-PD-1/PD-L1 antibodies must be established. This study explored serum cytokeratin fraction 21–1 (CYFRA 21-1), which represents a squamous cell histology, as a prognostic factor in anti-PD-1/PD-L1 antibody treatment, stratifying by histology and treatment regimen.Methods:This study retrospectively evaluated patients with advanced NSCLC without driver mutations receiving anti-PD-1/PD-L1 antibodies between November 2015 and March 2023. Cutoff values for CYFRA 21-1 and carcinoembryonic antigen (CEA) were 3.5 and 5.0 ng/mL, respectively. The Kaplan–Meier method and a log-rank test were conducted. The Cox proportional hazards model was utilized for univariate and multivariate analyses.Results:This study included 258 patients. The squamous NSCLC group demonstrated a shorter overall survival (OS) than the non-squamous NSCLC group (median, 17.8 vs. 23.7 months,p= 0.141). Patients with high serum CYFRA 21-1 and CEA levels exhibited a significantly shorter OS than those with normal levels (median, 11.7 vs. 32.7 months,p< 0.005; 15.8 vs. 29.7 months,p< 0.005). The multivariate analysis identified a performance status (PS) of ≥2, a PD-L1 expression of ≥50%, and a serum CYFRA 21-1 of >3.5 ng/mL as independent prognostic factors. Patients with high serum CYFRA 21-1 levels exhibited a significantly shorter OS even focusing on non-squamous NSCLC, anti-PD-1/PD-L1 antibody and chemotherapy combination therapy, or anti-CTLA-4 antibody combination therapy.Conclusion:Serum CYFRA 21-1 is a poor prognostic marker for patients with NSCLC receiving anti-PD-1/PD-L1 antibody treatment even when stratifying by histology or treatment regimen.
背景：在接受抗PD-1/PD-L1抗体治疗的非小细胞肺癌（NSCLC）患者中，必须建立预后标志物。本研究探讨了代表鳞状细胞组织学的血清细胞角蛋白片段21-1（CYFRA 21-1）作为抗PD-1/PD-L1抗体治疗预后因素的作用，并按组织学类型和治疗方案进行了分层分析。 方法：本研究回顾性评估了2015年11月至2023年3月期间接受抗PD-1/PD-L1抗体治疗、无驱动基因突变的晚期NSCLC患者。CYFRA 21-1和癌胚抗原（CEA）的截断值分别为3.5 ng/mL和5.0 ng/mL。采用Kaplan-Meier法和时序检验进行分析，并利用Cox比例风险模型进行单变量和多变量分析。 结果：本研究共纳入258例患者。鳞状NSCLC组的总生存期（OS）短于非鳞状NSCLC组（中位OS：17.8个月 vs. 23.7个月，p=0.141）。血清CYFRA 21-1和CEA水平高的患者，其OS显著短于水平正常的患者（中位OS：11.7个月 vs. 32.7个月，p<0.005；15.8个月 vs. 29.7个月，p<0.005）。多变量分析确定，体能状态（PS）≥2、PD-L1表达≥50%以及血清CYFRA 21-1 >3.5 ng/mL是独立的预后因素。即使在仅关注非鳞状NSCLC、抗PD-1/PD-L1抗体联合化疗或抗CTLA-4抗体联合治疗的患者中，血清CYFRA 21-1水平高的患者也表现出显著更短的OS。 结论：血清CYFRA 21-1是接受抗PD-1/PD-L1抗体治疗的NSCLC患者的不良预后标志物，即使在按组织学类型或治疗方案分层后亦是如此。
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