Abstract
PurposeThe aim of this study is to investigate the prognostic role of programmed death ligand-1 (PD-L1) on tumor-infiltrating immune cells (TIICs) in patients after radical cystectomy (RC) for bladder cancer (BCa).Materials and MethodsWe retrospectively reviewed 92 “high-risk” (≥pT3a and/or pN+) patients who underwent RC for BCa, without adjuvant chemotherapy (AC), between April 2014 and December 2019. PD-L1 on TIICs was measured only using the VENTANA (SP-142) immunohistochemistry assay. Patients were categorized into three groups based to the percentage of the tumor area covered by PD-L1 on TIICs: IC0 (<1%), IC1 (≥1% and <5%), and IC2/3 (≥5%). Positive PD-L1 was defined as IC2/3 (≥5%). Kaplan–Meier survival analysis was used to illustrate recurrence-free survival (RFS), and Cox proportional hazard models were used to identify predictive factors of tumor recurrence.ResultsWithin the cohort, the proportions of PD-L1 IC0, IC1, and IC2/3 were 21.7%, 23.9%, and 54.4%, respectively. At follow-up (mean 31.3 months), tumor recurrence was identified in 49 patients (53.3%). Using multivariable analysis, tumor stage (pT4; P=0.005), positive lymph nodes (P=0.021), and positive PD-L1 on TIICs (P=0.010) were independent predictors of tumor recurrence. The 2- and 3-year RFS rates were 67.7% and 64.2% in negative PD-L1 on TIICs, while 27.8% and 22.3% in positive PD-L1 on TIICs, respectively.ConclusionsPositive PD-L1 on TIICs was significantly associated with poorer RFS in “high-risk” patients after RC without AC. Our results support the use of adjuvant immunotherapy in “high-risk” patients with positive PD-L1 on TIICs after RC.
Highlights
The guidelines of European Association of Urology (EAU) on muscle-invasive bladder cancer (MIBC) recommend cisplatin-based combination adjuvant chemotherapy (AC) after radical cystectomy (RC) in high-risk patients (≥pT3a and/or pN+) if they did not receive neoadjuvant chemotherapy (NAC) [1]
In this study, we examined programmed death ligand-1 (PD-L1) on tumorinfiltrating immune cells (TIICs) in RC specimens to investigate the prognostic role of PD-L1 on TIICs as a predictive biomarker by analyzing the correlation with tumor recurrence in “high-risk” patients after RC
We excluded patients who were diagnosed with pT0-2N0 bladder cancer (BCa) following RC (n = 173) and who received NAC and/or radiation therapy or intravesical Bacillus CalmetteGuérin (BCG) instillation (n = 65)
Summary
The guidelines of European Association of Urology (EAU) on muscle-invasive bladder cancer (MIBC) recommend cisplatin-based combination adjuvant chemotherapy (AC) after radical cystectomy (RC) in high-risk patients (≥pT3a and/or pN+) if they did not receive neoadjuvant chemotherapy (NAC) [1]. About a third of patients only experience adverse events related to AC without treatment benefits [5]. For this reason, a novel strategy using immune checkpoint inhibitors is emerging as a promising therapeutic approach because of their relatively lower toxicities compared to chemotherapy [6, 7]. There are few studies on predictive biomarkers that can be used to choose patients suitable for adjuvant immunotherapy
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