Abstract
There are currently five programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) of the bladder. For platinum-ineligible patients, testing of tumor specimens for PD-L1 expression is required. However, scoring of PD-L1 immunohistochemistry is complex due to different antibodies used, the requirement to score expression in different cellular compartments and intratumoral heterogeneity. It can also be difficult to obtain and test longitudinal tumor samples, which would be desirable to monitor treatment responses and tumor evolution under treatment-induced selective pressure. In the present proof-of concept study, we provide evidence that PD-L1 can be detected in the urine of patients with non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). Urine PD-L1 levels were significantly higher in NMIBC and MIBC patients when compared to patients with various non-malignant urological diseases. Further prospective and independent studies are required to assess the value of PD-L1 in the urine as a novel biomarker with potential for the early detection, prediction and therapeutic monitoring of patients with UC of the bladder.
Highlights
There are currently five programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) of the bladder
Antibodies engineered to block PD-L1 or PD-1 have demonstrated therapeutic efficacy in patients with locally advanced or metastatic BCa11 leading to currently five PD-1/PD-L1 inhibitors approved for these patients[12]
What is the source of PD-L1 in the urine of bladder cancer (BCa) patients? To address this point, we prospectively collected urine from nine patients with urothelial carcinoma of the bladder and analyzed the specimens for urine PD-L1 levels, urine cytology and PD-L1 protein expression in urine exosomes (Supplementary Information, Fig. S1)
Summary
There are currently five programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) of the bladder. Further prospective and independent studies are required to assess the value of PD-L1 in the urine as a novel biomarker with potential for the early detection, prediction and therapeutic monitoring of patients with UC of the bladder. Antibodies engineered to block PD-L1 or PD-1 have demonstrated therapeutic efficacy in patients with locally advanced or metastatic BCa11 leading to currently five PD-1/PD-L1 inhibitors approved for these patients[12]. Two of these five PD-1/PD-L1 inhibitors, pembrolizumab and atezolizumab, are approved as first line agents in platinum-ineligible patients but require PD-L1 testing of the tumor tissue. In the present proof-of concept study, we analyzed whether PD-L1 can be detected in the urine of BCa patients to provide a simple, cost-effective and reliable biomarker to monitor and potentially help diagnose patients with BCa
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