文章：

PD-L1状态作为膀胱尿路上皮癌一线治疗预测性生物标志物的临床价值正在消失

The Vanishing Clinical Value of PD-L1 Status as a Predictive Biomarker in the First-Line Treatment of Urothelial Carcinoma of the Bladder

原文发布日期：17 April 2024

DOI: 10.3390/cancers16081536

类型: Article

开放获取: 是

英文摘要：

Background: Our study endeavors to elucidate the clinical implications of PD-L1 positivity in individuals afflicted with advanced urothelial carcinoma of the bladder (UCB). Methods: Patients with advanced UCB were prospectively enrolled following a radical cystectomy (RC) performed within January 2017 to December 2022 at our tertiary referral center. The clinical outcome, defined as the progression-free survival (PFS) and overall survival (OS) on systemic treatment, was analyzed using an χ2-test, Mann–Whitney U-test, the Kaplan–Meier method, and a log-rank test. Results: A total of 648 patients were included following an RC performed within January 2017 to December 2022. Their PD-L1 status was analyzed with the primary PD-L1-specific antibody (clone SP263, Ventana) and defined both by the CPS and IC-score in 282 patients (43.5%) with a high risk (pT3–pT4 and/or lymph node involvement) or metastatic UCB. While the median PFS was significantly prolonged 5-fold in PD-L1+ patients, we found no difference in OS, regardless of PD-L1 status, or treatment regimen. Conclusions: While PD-L1 positivity indicates prolonged PFS, the presence of PD-L1 does not influence OS rates, suggesting its limited usefulness as a prognostic biomarker in bladder cancer. However, the positive correlation between an PD-L1 status and a sustained response to ICI treatments indicates its potential role as a predictive biomarker. Further research is required to understand how the predictive value of PD-L1 positivity may extend to the use of ICIs in combination with antibody-drug conjugates.

摘要翻译： 

背景：本研究旨在阐明PD-L1阳性对晚期膀胱尿路上皮癌（UCB）患者的临床意义。方法：前瞻性纳入2017年1月至2022年12月期间在我院三级转诊中心接受根治性膀胱切除术（RC）的晚期UCB患者。采用χ²检验、Mann-Whitney U检验、Kaplan-Meier法和时序检验，分析以全身治疗的无进展生存期（PFS）和总生存期（OS）定义的临床结局。结果：共纳入2017年1月至2022年12月期间接受RC的648例患者。使用PD-L1特异性抗体（克隆SP263，Ventana）分析其PD-L1状态，并在282例（43.5%）高风险（pT3-pT4和/或淋巴结受累）或转移性UCB患者中，通过CPS和IC评分进行定义。结果显示，PD-L1阳性患者的中位PFS显著延长5倍，但无论PD-L1状态或治疗方案如何，OS均无差异。结论：PD-L1阳性虽可预示PFS延长，但其存在不影响OS率，提示其作为膀胱癌预后生物标志物的价值有限。然而，PD-L1状态与免疫检查点抑制剂（ICI）治疗的持续反应呈正相关，表明其作为预测性生物标志物的潜在作用。未来需进一步研究PD-L1阳性预测价值是否可扩展至ICI联合抗体药物偶联物的应用。

原文链接：

The Vanishing Clinical Value of PD-L1 Status as a Predictive Biomarker in the First-Line Treatment of Urothelial Carcinoma of the Bladder