@article{TAU155868,
author = {Hiromitsu Watanabe and Gaku Ishikawa and Shinya Watanabe and Shunsuke Watanabe and Kyohei Watanabe and Yuto Matsushita and Keita Tamura and Daisuke Motoyama and Teruo Inamoto},
title = {Clinical benefits, tolerability, and risk factors of adjuvant nivolumab for muscle-invasive bladder cancer},
journal = {Translational Andrology and Urology},
volume = {15},
number = {7},
year = {2026},
keywords = {},
abstract = {Background: In recent years, perioperative-sequential therapies have arisen for muscle-invasive bladder cancer (MIBC) treatment strategies. We are able to select more variable regimens for bladder cancer patients. This study aims to compare clinical outcomes in patients with MIBC who underwent robot-assisted radical cystectomy (RARC) followed by adjuvant nivolumab versus those who did not receive it.Methods: This retrospective single-center study included 60 patients with MIBC who underwent RARC between January 2017 and September 2025. Thirty patients who received adjuvant nivolumab (Nivo group), and 30 patients who did not (no-Nivo group). Disease-free survival (DFS), cancer-specific survival (CSS), and immune-related adverse events (irAEs) were evaluated. Survival analyses were performed using Kaplan-Meier curves and Cox proportional hazards regression models. Inverse probability of treatment weighting was used to adjust for baseline characteristics.Results: Median DFS was significantly longer in the Nivo compared with no-Nivo group [26.0 vs. 9.4 months, respectively; adjusted hazard ratio (aHR): 0.44; 95% confidence interval (CI): 0.22–0.88; P=0.02]. However, CSS did not differ significantly between them (aHR: 0.40; 95% CI: 0.14–1.10; P=0.08). Multivariable analysis identified ≥ pT3, pN+, and absence of nivolumab therapy as independent risk factors for poor DFS. Notably, pN+ remained a significant predictor of shorter DFS even in patients receiving nivolumab (aHR: 4.22; 95% CI: 1.19–15.1). irAEs occurred in 36.6% of patients in the Nivo group, with 13.3% experiencing grade ≥3 events, and three patients discontinued treatment due to toxicity.Conclusions: Adjuvant nivolumab significantly improved DFS in patients with high-risk MIBC in real-world practice; however, patients with pN+ remained at high risk for recurrence despite nivolumab, suggesting the need for more intensive therapeutic strategies in this subgroup.},
issn = {2223-4691}, url = {https://tau.amegroups.org/article/view/155868}
}