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. 2025 Jun 2;8(6):e2514427.
doi: 10.1001/jamanetworkopen.2025.14427.

Clinical Outcomes in Patients With Muscle-Invasive Urothelial Carcinoma Treated With Nivolumab

Regina Barragán-Carrillo  1 , Hedyeh Ebrahimi  1 , William S John  2 , Sarah Lucht  2 , Taavy A Miller  2 , Prathamesh Pathak  2 , Emily Bland  2 , Sarah Gordon  2 , JaLyna Laney  2 , Andrew J Klink  2 , Bruce Feinberg  2 , Nisha Singh  3 , Carmelo Alonso  3 , Miraj Y Patel  3 , Lisa Rosenblatt  3 , Xin Yin  3 , Alexander Chehrazi-Raffle  1
Affiliations

Clinical Outcomes in Patients With Muscle-Invasive Urothelial Carcinoma Treated With Nivolumab

Regina Barragán-Carrillo et al. JAMA Netw Open. .

Abstract

Importance: Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed.

Objective: To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting.

Design, setting, and participants: This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records.

Exposures: Diagnosis of MIUC and receipt of adjuvant nivolumab.

Main outcomes and measures: Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.

Results: Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free.

Conclusions and relevance: This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. Further research with extended follow-up is needed to elucidate long-term clinical outcomes of adjuvant nivolumab.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Barragán-Carrillo reported receiving personal fees from Pfizer, Ipsen, Exelixis, and Bayer during the conduct of the study. Dr Lucht reported being an employee of Cardinal Health and as such was not compensated directly by Bristol Myers Squibb (BMS) during the conduct of the study. Dr Klink reported receiving grants from BMS during the conduct of the study. Dr Feinberg reported being an employee of Cardinal Health during the conduct of the study. Dr Singh reported being an employee of BMS during the conduct of the study. Dr Alonso reported receiving personal fees from BMS outside the submitted work. Dr Patel reported receiving personal fees from BMS as an employee outside the submitted work. Dr Rosenblatt reported being an employee of BMS and receiving personal fees and owning stock in BMS outside the submitted work. Dr Yin reported being an employee of and receiving personal fees from BMS during the conduct of the study. Dr Chehrazi-Raffle reported receiving personal fees from Easai, Exelixis, and Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Treatment Sequencing, Including Neoadjuvant Therapy, Among Patients With Muscle-Invasive Urothelial Carcinoma Treated With Adjuvant Nivolumab
1L indicates first line; 2L, second line; DDMVAC, dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin.
Figure 2.
Figure 2.. Survival of Patients With Muscle-Invasive Urothelial Carcinoma From Initiation of Adjuvant Nivolumab
Graphs show Kaplan-Meier curves for overall survival (A) and disease-free survival (B). NE indicates not estimable; NR, not reported.
See this image and copyright information in PMC

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