Trial reportInternational journal of clinical oncology2022
Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis.
Trial report in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02603432 (A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A phase 3, multicenter, multinational, randomized, open-label, parallel-arm study of avelumab (msb0010718c) plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after completion of first-line platinum-containing chemotherapy
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effects of different exercise interventions on lower back pain: a systematic review and meta-analysis.Frontiers in physiology · 2025Pooled it
- Trial
- Adjuvant nivolumab versus placebo following radical surgery for high-risk muscle-invasive urothelial carcinoma: a subgroup analysis of Japanese patients enrolled in the phase 3 CheckMate 274 trial.Japanese journal of clinical oncology · 2023Trial
- 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
- Article
- JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan.ESMO real world data and digital oncology · 2025Article
- JAVEMACS-D: claims database analysis of avelumab maintenance therapy for advanced urothelial carcinoma in Japan.Scientific reports · 2025Observational
- Article
- 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
- Efficacy and safety of adjuvant nivolumab after radical surgery for high-risk urothelial carcinoma: a preliminary report of real-world data from a single institution.International journal of clinical oncology · 2024Article
- Review
- J-AVENUE: A retrospective, real-world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first-line maintenance therapy in Japan.International journal of urology : official journal of the Japanese Urological Association · 2024Article
- Summary of the Clinical Practice Guidelines for Upper Tract Urothelial Carcinoma 2023 by the Japanese Urological Association.International journal of urology : official journal of the Japanese Urological Association · 2024Review
- Oral manifestation associated with avelumab.Oral oncology reports · 2024Article
- Hyperprogressive disease after avelumab maintenance therapy in a patient with advanced ureter cancer: A case report.Urology case reports · 2022Article
- Clinical evidence and insights supporting the use of avelumab first-line maintenance treatment in patients with advanced urothelial carcinoma in the Asia-Pacific region.Asia-Pacific journal of clinical oncology · 2022Review
- Survival and Safety Outcomes of Avelumab Maintenance Therapy for Advanced Urothelial Carcinoma from a Single-Center Experience.In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe phase 3 JAVELIN Bladder 100 trial showed significantly prolonged overall survival (OS) with avelumab as first-line (1L) maintenance therapy + best supportive care (BSC) vs BSC alone in patients with advanced urothelial carcinoma (UC) that had not progressed with 1L platinum-containing chemotherapy. Efficacy and safety were assessed in patients enrolled in Japan.
methodsPatients with locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L platinum-containing chemotherapy were randomized to avelumab (10 mg/kg intravenously every 2 weeks) + BSC or BSC alone. The primary endpoint was OS, and secondary endpoints included progression-free survival (PFS) and safety.
resultsIn Japanese patients (n = 73) randomized to avelumab + BSC (n = 36) or BSC alone (n = 37), median OS was 24.7 months (95% CI, 18.2-not estimable) vs 18.7 months (95% CI, 12.8-33.0), respectively (HR, 0.81 [95% CI, 0.41-1.58]), and median PFS was 5.6 months (95% CI, 1.9-9.4) vs 1.9 months (95% CI, 1.9-3.8), respectively (HR, 0.63 [95% CI, 0.36-1.11]). In the avelumab + BSC and BSC-alone arms, grade ≥ 3 treatment-emergent adverse events (AEs) occurred in 50.0% vs 8.1%, including grade ≥ 3 treatment-related AEs in 13.9% vs 0%, respectively. Efficacy and safety results in Japanese patients were generally consistent with findings in the overall trial population.
conclusionAvelumab 1L maintenance treatment showed a favorable benefit-risk balance in Japanese patients, supporting avelumab 1L maintenance as a new standard of care in Japanese patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy.
trial registrationClinicaltrials.gov NCT02603432.
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