In the expanding landscape of immune checkpoint inhibitors (CPI) in high-risk (HR) non-muscle-invasive bladder cancer (NMIBC), the role of programmed death ligand 1 (PD-L1) as prognostic and predictive is increasingly significant. However, data evaluating its variability and susceptibility to Bacillus Calmette–Guérin (BCG) therapy in HR NMIBC patients is scarce. This retrospective study analyzed 126 HR NMIBC tissue samples from 63 patients (38× BCG-treated, 25× BCG-naïve) at two time points to assess PD-L1 expression using the ‘combined positivity score’ (CPS) with the 22C3 DAKO antibody method and correlated it with clinicopathological parameters. A CPS > 10 defined PD-L1 positivity. The impact of initial PD-L1 status and its change over time on time-to-recurrence, progression-free survival, and overall survival (TTR, PFS, OS) was analyzed using Kaplan–Meier and Cox proportional hazard models. BCG treatment significantly increased PD-L1 expression (5.31 vs. 0.22,p= 0.0423), with PD-L1 positive cases rising post-treatment in the BCG group and remaining unchanged in BCG-naïve patients. Multivariate analysis including T-stage, CIS, grading, tumor size, multifocality, age, and sex revealed a significant correlation between PD-L1 status change to positivity and improved TTR (p= 0.03). Our findings demonstrate a potential modulation of the PD-L1 status by an intravesical BCG therapy. However, its prognostic value appears limited.
在高危非肌层浸润性膀胱癌免疫检查点抑制剂应用不断拓展的背景下，程序性死亡配体1的预后与预测价值日益凸显。然而，关于PD-L1在高危非肌层浸润性膀胱癌患者中的表达异质性及其对卡介苗治疗敏感性的研究数据仍较为匮乏。本回顾性研究通过22C3 DAKO抗体法采用"联合阳性评分"系统，对63例高危非肌层浸润性膀胱癌患者（38例接受卡介苗治疗，25例未接受治疗）在两个时间点采集的126份组织样本进行PD-L1表达分析，并将其与临床病理参数进行相关性研究。研究将CPS>10定义为PD-L1阳性状态。通过Kaplan-Meier法和Cox比例风险模型分析初始PD-L1状态及其动态变化对无复发生存期、无进展生存期和总生存期的影响。结果显示卡介苗治疗显著提升PD-L1表达水平（5.31 vs. 0.22，p=0.0423），治疗组患者PD-L1阳性病例数治疗后显著增加，而未治疗组保持稳定。纳入T分期、原位癌、分级、肿瘤大小、多灶性、年龄和性别等多因素分析表明，PD-L1状态转为阳性与改善的无复发生存期显著相关（p=0.03）。本研究证实膀胱内卡介苗治疗可能调控PD-L1表达状态，但其预后价值似乎有限。
肿瘤(癌症)患者之家