e16562 Background: Adjuvant nivolumab improves outcomes in high-risk muscle-invasive bladder cancer (MIBC) when initiated within 120 days of radical cystectomy, but optimal timing in real-world practice remains uncertain. Postoperative recovery, neoadjuvant chemotherapy (NAC), and logistical barriers often delay treatment. We evaluated whether earlier initiation of adjuvant nivolumab is associated with improved survival outside of clinical trials. Methods: We performed a retrospective cohort study using the TriNetX database (2017–2024), including adults with bladder cancer who underwent radical cystectomy followed by adjuvant nivolumab. Patients who underwent neoadjuvant chemotherapy were excluded. Patients were stratified by time from cystectomy to nivolumab initiation: <60 days vs 60–180 days. Cohorts were propensity score matched (1:1) on age, sex, race, comorbidities, and treatment history. Overall survival (OS) and time to next treatment (TTNT) were evaluated using Kaplan–Meier methods and log-rank testing. Results: In the primary analysis, both matched cohorts included 114 patients initiating nivolumab <60 days and 60–180 days after cystectomy. At 1 year, OS was significantly higher in the < 60-day group (88% vs 75%; p = 0.009). At 3 years, earlier initiation of nivolumab < 60 was still associated with a significantly higher OS (72% vs 53%; p = 0.016). No significant difference in TTNT was observed (56 vs 56 days; p = 0.808). Conclusions: Early initiation of adjuvant nivolumab within 60 days of radical cystectomy is associated with improved overall survival in real-world bladder cancer patients. These findings support timely postoperative initiation of immunotherapy when clinically feasible. These results should be interpreted cautiously due to the limited sample size. Further studies incorporating a larger sample size are warranted.
Chan et al. (Thu,) studied this question.