Trial reportCancer medicine2025
Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Subgroup Analyses of Post-Marketing Surveillance Data by Age, Prior Chemotherapy Regimen, and Best Overall Response to Prior Chemotherapy.
Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Trial
- Real-World Use of Avelumab First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma in Japan: Treatment Patterns, Effectiveness, and Safety.International journal of urology : official journal of the Japanese Urological Association · 2026Review
- Real-World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance.Cancer medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
introductionAvelumab maintenance therapy was approved in Japan for curatively unresectable urothelial carcinoma (UC) without progression after prior platinum-based chemotherapy (PBC) based on results from the JAVELIN Bladder 100 phase 3 trial. We report post hoc analyses of post-marketing surveillance (PMS) data in subgroups defined by age, prior PBC regimen, and best overall response (BOR) to prior PBC.
methodsPatients with curatively unresectable UC who received ≥ 1 dose of avelumab maintenance in Japan between February and December 2021 were evaluated. The primary objective was to evaluate safety based on prespecified adverse drug reactions (ADRs). The secondary objective was to evaluate effectiveness, including time to treatment failure (TTF; discontinuation for any reason) and overall survival (OS).
resultsThe analysis population included 453 patients. In patients aged ≤ 64 (n = 75), 65 to 74 (n = 198), or ≥ 75 (n = 180) years, prespecified ADRs occurred in 17 (22.7%), 69 (34.9%), and 58 (32.2%); median TTF was 4.8, 4.4, and 4.9 months; and 12-month OS rates were 77.6%, 82.7%, and 72.6%, respectively. In patients with prior cisplatin + gemcitabine (n = 267), carboplatin + gemcitabine (n = 163), or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (n = 9) treatment, prespecified ADRs occurred in 93 (34.8%), 45 (27.6%), and 3 (33.3%); median TTF was 4.6, 4.6, and 5.1 months; and 12-month OS rates were 79.6%, 73.8%, and 88.9%, respectively. In patients with prior complete response (n = 47), partial response (n = 242), or stable disease (n = 149), prespecified ADRs occurred in 16 (34.0%), 79 (32.6%), and 45 (30.2%); median TTF was 5.2, 4.6, and 4.6 months; and 12-month OS rates were 89.4%, 76.3%, and 75.8%, respectively. DISCUSSION: In this PMS population, safety and effectiveness were observed with avelumab maintenance therapy across subgroups defined by age, prior PBC regimen, or BOR to prior PBC. Findings support the favorable benefit-risk profile of avelumab maintenance in clinical practice.
trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: UMIN 43435).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.