Lymphovascular invasion and nodal positivity may identify candidates for adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma.

OBJECTIVE: To identify patients with high-risk muscle-invasive urothelial carcinoma (MIUC) who derive greater benefit from adjuvant nivolumab after radical surgery. PATIENTS AND METHODS: This single-center retrospective study included 246 patients with high-risk MIUC who underwent radical surgery between 2018 and 2025. High-risk disease was defined according to the CheckMate 274 trial criteria. The real-world oncological outcomes of patients who received adjuvant nivolumab (n = 51) were compared with those of a contemporary control cohort (n = 51) and a historical control cohort (n = 144). Prognostic factors for disease-free survival (DFS) in nivolumab-naïve patients were evaluated using multivariate Cox regression analysis. DFS for the entire cohort was stratified according to significant prognostic factors and nivolumab use. RESULTS: The adjuvant nivolumab cohort showed favorable oncological outcomes compared to both the contemporary and historical control cohorts. Multivariate analysis identified lymphovascular invasion (LVI) and nodal positivity as independent prognostic factors in nivolumab-naïve patients. In patients with LVI or nodal positivity, those who received adjuvant nivolumab had a significantly improved DFS compared with those who did not (hazard ratio 0.40; 95% confidence interval, 0.22-0.73; log-rank P = 0.002). However, in patients with neither LVI nor nodal positivity, DFS did not differ significantly according to adjuvant nivolumab use (P = 0.66). CONCLUSION: Our findings suggest that LVI and nodal positivity may help identify patients with high-risk MIUC who are more likely to benefit from adjuvant nivolumab. These pathological features may serve as practical markers for patient selection; however, further validation is required before clinical implementation.