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Drugs blocking programmed death ligand‐1 ( PD ‐L1) have shown unprecedented activity in metastatic and unresectable bladder cancer. The purpose of the present study was to investigate the expression, clinical significance and association of  PD ‐L1 with tumor‐infiltrating lymphocytes ( TIL ) in resectable urothelial cell carcinoma of the bladder ( UCB ). In this retrospective study, 248  UCB  patients who received radical cystectomy or transurethral resection were examined. Immunohistochemistry was used to evaluate  PD ‐L1 expression and stromal  CD 8 +   TIL , Th1 orientation T cell (T‐bet + ) and  PD ‐1 +   TIL  densities within the intratumoral regions and associated stromal regions. Of the 248 specimens, 23% showed  PD ‐L1 expression in tumor cells and 55% in tumor‐infiltrating immune cells.  CD 8 +   TIL , T‐bet +   TIL  and  PD ‐1 +   TIL  were distributed throughout the tumor tissues and were more frequently distributed in stromal regions than in intratumoral regions.  PD ‐L1 +  tumor cells and  PD ‐L1 +  immune cells were positively associated with aggressive clinical features (all  P  < .05). Both  PD ‐L1 +  tumor cells and  PD ‐L1 +  immune cells were associated with poorer recurrence‐free and overall survival (all  P  < .05). Multivariate analysis showed that  PD ‐L1 +  immune cells were an independent prognostic factor for overall ( P  = .001) and recurrence‐free survival ( P  = .024). Notably, high stromal  CD 8 +   TIL  and  PD ‐1 +   TIL  density were associated with poorer overall survival ( P  = .031 and  P  = .001, respectively). In the stroma,  CD 8 +   TIL  density has strong positive association with  PD ‐L1 +  immune cells and  PD ‐1 +   TIL  density (all  P  < .0001). These results suggested that an exhausted immune state occurred in the tumor stroma in  UCB . Further clinical development of immune‐checkpoint inhibitors may be effective for resectable patients with  UCB .

Programmed death ligand‐1 is associated with tumor infiltrating lymphocytes and poorer survival in urothelial cell carcinoma of the bladder