Oncological Outcomes and Safety Profiles of Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinoma.
5 affiliations
- 1Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
- 2Department of Urology, The Jikei University School of Medicine, Tokyo, Japan.
- 3Department of Urology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
- 4Department of Urology, National Hospital Organization Iwakuni Clinical Center, Yamaguchi, Japan.
- 5Department of Urology, Shimane University Hospital, Shimane, Japan.
Abstract
Objectives
Perioperative immunotherapy has become the standard of care in patients with high-risk muscle-invasive urothelial carcinoma (MIUC). This study aimed to clarify oncological outcomes and safety profiles of adjuvant nivolumab therapy in MIUC, focusing on upper tract urothelial carcinoma (UTUC).Methods
This multicenter study comprised 97 patients undergoing removal of primary tumors, followed by adjuvant nivolumab therapy with a potential follow-up period ≥ 12 months. Patients were divided according to the primary tumor location: bladder cancer (BC), n = 66 (68%); UTUC, n = 31 (32%). Multivariable Cox regression analyses were applied to identify prognostic factors for disease-free survival (DFS).Results
Before surgery, 38% of patients had an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m², but this proportion increased to 57% at nivolumab initiation with 19% of UTUC having eGFR < 30. The overall DFS at 6 months was 61.5%. DFS did not differ significantly between BC and UTUC (p = 0.83). On multivariable analyses, a higher absolute eosinophil count was significantly associated with worse DFS (HR 2.24; 95% CI, 1.24-4.03, p = 0.007), while primary tumor location was not. Immune-related adverse events (irAEs) of adrenal insufficiency and hypophysitis occurred in 8% and 4% of patients, respectively, with grade ≥ 3 occurring at 3.3-18.3 months.Conclusions
Adjuvant nivolumab therapy may provide comparable oncological outcomes between BC and UTUC. Baseline eosinophil count was an independent prognosticator for DFS. The incidences of adrenal insufficiency and hypophysitis appeared higher in our real-world data. Clinicians should recognize these irAEs due to nonspecific symptoms and considerable variability in time of onset.
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BibTeX
@article{katayama2026oncological,
title = {{Oncological Outcomes and Safety Profiles of Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinoma.}},
author = {Satoshi Katayama and Tatsushi Kawada and Keiichiro Mori and Kosuke Iwatani and Shota Inoue and Tomofumi Watanabe and Ichiro Tsuboi and Tomoaki Yamanoi and Takehiro Iwata and Kazuma Tsuboi and Wataru Murao and Tetsuya Nakada and Kohei Ogawa and Akihiro Matsukawa and Takafumi Yanagisawa and Shingo Nishimura and Kensuke Bekku and Koichiro Wada and Takahiro Kimura and Motoo Araki},
journal = {International journal of urology : official journal of the Japanese Urological Association},
year = {2026},
month = oct,
doi = {10.1111/iju.70664},
url = {https://europepmc.org/article/MED/42897807},
note = {CC BY},
}
RIS
TY - JOUR
TI - Oncological Outcomes and Safety Profiles of Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinoma.
AU - Satoshi Katayama
AU - Tatsushi Kawada
AU - Keiichiro Mori
AU - Kosuke Iwatani
AU - Shota Inoue
AU - Tomofumi Watanabe
AU - Ichiro Tsuboi
AU - Tomoaki Yamanoi
AU - Takehiro Iwata
AU - Kazuma Tsuboi
AU - Wataru Murao
AU - Tetsuya Nakada
AU - Kohei Ogawa
AU - Akihiro Matsukawa
AU - Takafumi Yanagisawa
AU - Shingo Nishimura
AU - Kensuke Bekku
AU - Koichiro Wada
AU - Takahiro Kimura
AU - Motoo Araki
PY - 2026
DA - 2026/10/01
JO - International journal of urology : official journal of the Japanese Urological Association
DO - 10.1111/iju.70664
UR - https://europepmc.org/article/MED/42897807
AB - Objectives Perioperative immunotherapy has become the standard of care in patients with high-risk muscle-invasive urothelial carcinoma (MIUC). This study aimed to clarify oncological outcomes and safety profiles of adjuvant nivolumab therapy in MIUC, focusing on upper tract urothelial carcinoma (UTUC).Methods This multicenter study comprised 97 patients undergoing removal of primary tumors, followed by adjuvant nivolumab therapy with a potential follow-up period ≥ 12 months. Patients were divided according to the primary tumor location: bladder cancer (BC), n = 66 (68%); UTUC, n = 31 (32%). Multivariable Cox regression analyses were applied to identify prognostic factors for disease-free survival (DFS).Results Before surgery, 38% of patients had an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m², but this proportion increased to 57% at nivolumab initiation with 19% of UTUC having eGFR < 30. The overall DFS at 6 months was 61.5%. DFS did not differ significantly between BC and UTUC (p = 0.83). On multivariable analyses, a higher absolute eosinophil count was significantly associated with worse DFS (HR 2.24; 95% CI, 1.24-4.03, p = 0.007), while primary tumor location was not. Immune-related adverse events (irAEs) of adrenal insufficiency and hypophysitis occurred in 8% and 4% of patients, respectively, with grade ≥ 3 occurring at 3.3-18.3 months.Conclusions Adjuvant nivolumab therapy may provide comparable oncological outcomes between BC and UTUC. Baseline eosinophil count was an independent prognosticator for DFS. The incidences of adrenal insufficiency and hypophysitis appeared higher in our real-world data. Clinicians should recognize these irAEs due to nonspecific symptoms and considerable variability in time of onset.
SN - 0919-8172
SN - 1442-2042
ER -