Prognostic Value of Programmed Death Ligand-1 Expression on Tumor-Infiltrating Immune Cells in Patients Treated with Cisplatin-Based Combination Adjuvant Chemotherapy Following Radical Cystectomy for Muscle-Invasive Bladder Cancer: A Retrospective Cohort Study.

Purpose To investigate the prognostic value of programmed death ligand-1 (PD-L1) expression in tumor-infiltrating immune cells (ICs) in men treated with adjuvant chemotherapy (AC) following radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC). Materials and Methods We retrospectively reviewed 219 “high-risk” (≥pT3a and/or pN+) patients who underwent RC and received cisplatin-based AC for MIBC between March 2015 and September 2019. PD-L1 expression was measured using the VENTANA (SP-142) immunohistochemistry assay and categorized into the three groups according to the percentage of the tumor area covered by PD-L1 expression on ICs: IC0 (<1%), IC1 (≥1% and <5%), and IC2/3 (≥5%). Positive PD-L1 expression was defined as IC2/3 (≥5%). Kaplan–Meier survival analysis was used to assess recurrence-free survival (RFS), and Cox proportional hazard models were applied to identify factors predicting tumor recurrence. Results In the entire cohort, the overall prevalence of PD-L1 IC0, IC1, and IC2/3 was 13.2%, 27.4%, and 59.4%, respectively. During the mean follow-up of 32.5 months, tumor recurrence was detected in 115 (52.5%) patients. On multivariable analysis, tumor stage (≥pT3; P=0.032), positive lymph nodes (P=0.001), and positive PD-L1 on ICs (P=0.005) were independent predictors of tumor recurrence. The 3 year RFS was 54.7% in patients with negative PD-L1 and 31.7% in patients with positive PD-L1. Conclusion PD-L1 is widely expressed in ICs. Positive PD-L1 on ICs was significantly associated with shorter RFS in patients treated with cisplatin-based AC following RC. The present results support the use of adjuvant immunotherapy in “high-risk” patients with PD-L1-expressing ICs.