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. 2025 Oct;32(10):1449-1459.
doi: 10.1111/iju.70162. Epub 2025 Jul 2.

Response to First-Line Chemotherapy Predicts Response to Maintenance Avelumab Therapy in Japanese Patients With Advanced Urothelial Carcinoma

Satoshi Inoue  1 , Akira Hayakawa  2 , Mikinori Kobayashi  3 , Yuriko Nagasaka  4 , Takanao Omi  5 , Noritoshi Shamoto  6 , Fumihiro Ito  7 , Takuma Yuba  8 , Yuri Yuguchi  9 , Hideji Kawanishi  10 , Kosuke Tochigi  2 , Shusuke Akamatsu  1
Affiliations

Response to First-Line Chemotherapy Predicts Response to Maintenance Avelumab Therapy in Japanese Patients With Advanced Urothelial Carcinoma

Satoshi Inoue et al. Int J Urol. 2025 Oct.

Abstract

Objectives: The association between the response to first-line chemotherapy and maintenance of avelumab remains unclear. We identified factors associated with the response to avelumab in patients with advanced urothelial carcinoma using real-world data.

Methods: We retrospectively enrolled 100 patients with advanced urothelial carcinoma treated with maintenance avelumab therapy between March 2021 and April 2024 at Nagoya University and nine affiliated hospitals. The complete/partial-response group was defined as patients with complete response or partial response as the best response to first-line chemotherapy. The stable disease group was defined as patients with stable disease as the best response to first-line chemotherapy.

Results: Seven patients (7.0%) achieved complete response, 65 (65.0%) achieved partial response, and 28 (28.0%) achieved stable disease as the best response to first-line chemotherapy. Regarding avelumab therapy, the complete/partial-response group had significantly better progression-free survival than the stable disease group (median: 11.1 vs. 3.2 months, p < 0.001). In multivariate analyses, the best response to first-line chemotherapy was the only independent risk factor for progression-free survival (hazard ratio = 1.844, 95% confidence interval = 1.002-3.394; p = 0.049). Overall survival was significantly shorter in the stable disease group than in the complete/partial-response group (median: 14.1 months vs. not reached, p < 0.001). Multivariate analyses revealed significant associations between poor overall survival and performance status (hazard ratio = 2.175, 95% confidence interval = 1.030-4.592; p = 0.042) and the best response to first-line chemotherapy (hazard ratio = 4.174, 95% confidence interval = 1.975-8.824; p < 0.001).

Conclusions: The best response to first-line chemotherapy may predict the clinical outcome of patients with advanced urothelial carcinoma treated with avelumab.

Keywords: avelumab; carcinoma; immunotherapy; prognosis; risk factors.

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Conflict of interest statement

Shusuke Akamatsu is an Editorial Board member of the International Journal of Urology and a co‐author of this article. To minimize bias, he was excluded from all editorial decision‐making related to the acceptance of this article for publication. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Clinical responses to first‐line (1 L) chemotherapy and avelumab treatment. (a) Frequency of best overall response to avelumab in all patients, the CR/PR group, and the SD group. Kaplan–Meier curve for time to progression‐free survival (PFS) and overall survival (OS) in patients. (b) PFS of all patients. (c) PFS of all patients according to the best response to first‐line (1 L) chemotherapy. (d) OS of all patients. (e) OS of all patients according to the best response to 1 L chemotherapy. CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease.
FIGURE 2
FIGURE 2
Kaplan–Meier curve for time to additional progression‐free survival (a) and additional overall survival (b) in patients who received 1 year of avelumab.
See this image and copyright information in PMC

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