Background:Nivolumab plus chemotherapy has shown significant benefits in advanced gastric cancer (AGC) patients with PD-L1 combined positive score (CPS) 5 or higher. However, real-world data on its efficacy across different PD-L1 expression levels are limited.Methods:We conducted a retrospective analysis of 143 AGC patients treated with first-line nivolumab plus chemotherapy. Patients were stratified by PD-L1 CPS. Progression-free survival (PFS), overall survival (OS), and clinical factors affecting outcomes were evaluated.Results:Among 143 patients, 87 (60.8%) were classified as PD-L1 CPS < 5 and 56 (39.2%) as CPS ≥ 5. The PD-L1 ≥ 5 group had a higher proportion of dMMR and TMB-high. Notably, patients in the PD-L1 < 5 group also derived a PFS benefit from chemotherapy plus nivolumab, achieving a median PFS of 6.8 months, although outcomes were further enhanced in the PD-L1 ≥ 5 group with statistical significance (10.0 months; HR 0.56,p= 0.004). Although the PD-L1 ≥ 5 group showed a higher median OS compared with the PD-L1 < 5 group (26.2 vs. 18.8 months), the difference was not statistically significant (p= 0.234). Exploratory analyses demonstrated a stepwise trend toward improved survival with increasing PD-L1 cutoffs, with the most pronounced benefit observed in the PD-L1 ≥ 25 subgroup (PFS HR 0.28,p= 0.012; OS HR 0.21,p= 0.031).Conclusions:This real-world study suggests that nivolumab plus chemotherapy may benefit AGC patients across various PD-L1 expression levels, with trends favoring higher expression. These findings warrant further investigation in larger real-world studies to optimize patient selection and treatment strategies.
背景：纳武利尤单抗联合化疗在程序性死亡配体1（PD-L1）联合阳性评分（CPS）≥5的晚期胃癌患者中已显示出显著获益。然而，关于其在不同PD-L1表达水平患者中疗效的真实世界数据仍较为有限。 方法：我们对143例接受一线纳武利尤单抗联合化疗的晚期胃癌患者进行回顾性分析。根据PD-L1 CPS对患者进行分层，评估无进展生存期（PFS）、总生存期（OS）以及影响预后的临床因素。 结果：在143例患者中，87例（60.8%）为PD-L1 CPS < 5，56例（39.2%）为CPS ≥ 5。PD-L1 ≥ 5组中错配修复缺陷（dMMR）和肿瘤突变负荷高（TMB-high）患者比例更高。值得注意的是，PD-L1 < 5组患者同样从化疗联合纳武利尤单抗治疗中获得PFS获益，中位PFS达6.8个月，而PD-L1 ≥ 5组的疗效进一步改善且具有统计学意义（10.0个月；HR 0.56，p=0.004）。尽管PD-L1 ≥ 5组中位OS较PD-L1 < 5组更长（26.2个月 vs. 18.8个月），但差异无统计学意义（p=0.234）。探索性分析显示，随着PD-L1截断值的提高，生存获益呈现阶梯式改善趋势，其中PD-L1 ≥ 25亚组的获益最为显著（PFS HR 0.28，p=0.012；OS HR 0.21，p=0.031）。 结论：本真实世界研究表明，纳武利尤单抗联合化疗可能使不同PD-L1表达水平的晚期胃癌患者获益，且表达水平越高获益趋势越明显。这些发现值得在更大规模的真实世界研究中进一步验证，以优化患者选择和治疗策略。
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