Asia-Pacific journal of clinical oncology
November 11, 2025 · via Europe PMC
Real-World Efficacy of Postoperative Adjuvant Nivolumab in High-Risk Urothelial Carcinoma: A Retrospective Comparative Study in an Asian Population.
Nakagawa R, Naito R, Izumi K, +12 more, Mizokami A.
AI summary — for doctors, generated from the abstract only
In a Japanese real-world comparison with historical controls, adjuvant nivolumab after radical surgery for high-risk urothelial carcinoma was associated with substantially better recurrence-free survival.
What was studied
A retrospective single-institution study of 158 patients after radical surgery for high-risk urothelial carcinoma: 20 received adjuvant nivolumab and 138 historical controls received no adjuvant therapy.
Key findings
- RFS HR 0.21 (0.10-0.42); multivariable HR 0.18
- OS not significantly different (HR 0.32, p=0.22)
- 55% completed 1 year of therapy; 25% discontinued for AEs (including 3 ILD cases)
Clinical relevance
This is consistent with CheckMate 274 in an Asian population. The very small treated group and historical controls make the effect size unreliable.
Who should care
Limitations
Small treated group (n=20), historical controls, different follow-up durations and single center.
Adjuvant nivolumab appears beneficial in Asian patients too, though this study is small.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Purpose
To evaluate the real-world effectiveness of adjuvant nivolumab following radical surgery in patients with high-risk urothelial carcinoma, using historical data for comparison.
Materials and methods
Patients who underwent radical surgery at our institution were retrospectively analyzed. They were divided into two groups: one group received adjuvant nivolumab, and the other received no adjuvant therapy. Oncological outcomes, adverse events, and treatment completion rates were assessed.
Results
A total of 158 patients were included: 20 in the adjuvant nivolumab group and 138 in the control group. The median observation periods were 20.4 months in the nivolumab group and 36.7 months in the control group. The nivolumab group showed significantly improved recurrence-free survival compared to the control group (hazard ratio: 0.21; 95% confidence interval: 0.10-0.42; p = 0.01). Although overall survival tended to improve in the nivolumab group, the difference was not statistically significant (hazard ratio: 0.32; 95% confidence interval: 0.01-1.01; p = 0.22). Multivariate analysis confirmed adjuvant nivolumab as a significant favorable prognostic factor for recurrence-free survival (hazard ratio: 0.18; 95% confidence interval: 0.044-0.73; p = 0.017). One-year treatment was completed in 55.0% of patients. Adverse events led to discontinuation in 25.0%, with major events including interstitial lung disease (three patients), hormonal disorders such as isolated adrenocorticotropic hormone deficiency (2), rash (3), hypothyroidism (1), and hepatitis (1).
Conclusion
Adjuvant nivolumab demonstrated clinical benefit in Asian patients with high-risk urothelial carcinoma in a real-world setting.
DOI
10.1111/ajco.70051
PMID
41220193
PMCID
PMC13568861
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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