Trial reportEuropean urology2022
Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial.
Trial report in European urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03219333 (A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.
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.
A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Enfortumab Vedotin With or Without Pembrolizumab in Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Antibody-drug conjugates as game changers in bladder cancer: current progress and future directions.Frontiers in immunology · 2025Pooled it
- Efficacy and safety of the first-line systemic treatments in patients with advanced-stage urothelial carcinoma: a systematic review and network meta-analysis.Frontiers in oncology · 2024Pooled it
- Fibroblast growth factor receptor 3 mutation attenuates response to immune checkpoint blockade in metastatic urothelial carcinoma by driving immunosuppressive microenvironment.Journal for immunotherapy of cancer · 2023Pooled it
- Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Infectious Complications of Antibody-Drug Conjugates: A Review of Safety Data from FDA-Approved Agents.Current oncology reports · 2026Review
- Toripalimab plus disitamab vedotin versus tislelizumab-based combination in advanced urothelial carcinoma: a real-world comparative study.BMC cancer · 2026Article
- Bioinformatics profiling of NECTIN4 in lung cancer and comparative evaluation of NECTIN4-targeted ⁶⁸Ga-N188 and ¹⁸F-FDG PET/CT.Journal of translational medicine · 2026Article
- Antibody-Drug Conjugates in Oncology: Principles, Clinical Development, and Future Directions.MedComm · 2026Review
- Assessing the patient reported outcomes (PROs) of enfortumab vedotin plus pembrolizumab versus platinum-based chemotherapy in patients with advanced urothelial carcinoma in the EV-302 study.Translational andrology and urology · 2026Article
- A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers.Molecular cancer · 2024Review
- The Relationship Between the Number of Chronic Diseases and Health-Related Quality of Life Among Middle-Aged and Older Adults in Rural Areas of Yunnan Province, China: moderating Effect of Health Lifestyle.Journal of multidisciplinary healthcare · 2024Article
- Post-marketing drug safety surveillance of enfortumab vedotin: an observational pharmacovigilance study based on a real-world database.Frontiers in immunology · 2024Observational
- Advances in Diagnosis and Therapy for Bladder Cancer.Cancers · 2022Review
- Quality-of-Life Outcomes in Female Patients With Ileal Conduit or Orthotopic Neobladder Urinary Diversion: 6-Month Results of a Multicenter Prospective Study.Frontiers in oncology · 2022Article
- Systematic review of recent advancements in antibody-drug and bicycle toxin conjugates for the treatment of urothelial cancer.Therapeutic advances in urologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundThe EV-201 trial (NCT03219333) demonstrated a clinically meaningful and durable response rate and a tolerable safety profile with enfortumab vedotin (EV) in patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) treated with prior PD-1/PD-L1 inhibitor therapy and platinum-containing chemotherapy (cohort 1). Patient-reported outcome (PRO) measures were included in EV-201 as exploratory endpoints.
objectiveTo evaluate PRO data for cohort 1 of EV-201 to better understand the relationship between EV therapy and health-related quality of life (HRQoL). DESIGN, SETTING, AND
participantsEnrolled patients with LA/mUC who received EV were invited to electronically complete two HRQoL instruments (EORTC QLQ-C30 and EQ-5D-3L) at baseline and day 1 of each cycle until treatment discontinuation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patient demographics, completion and compliance rates, and PRO scores were analysed using descriptive statistics. Selected EORTC QLQ-C30 scores were analysed post hoc using a repeated-measures mixed model. RESULTS AND LIMITATIONS: Among treated patients (n = 125), 95% completed both baseline questionnaires. Compliance rates were ≥86% throughout the study. Descriptive analyses showed that global health status, physical functioning, and symptom scores remained stable over time, with average scores similar at each cycle. Lower pain and fatigue scores were observed in responders at cycles following an objective response. Pain was lower at cycle 3 than at baseline in patients with bone metastases. Mean EQ-5D-3L utility score (0.80 at baseline; range from 0.77 at cycle 2 to 0.91 at cycle 10) and visual analogue scale scores (66.9 at baseline; range from 65.5 at cycle 2 to 78.4 at cycle 10) remained similar over time. Variability and the small sample size limited definitive conclusions.
conclusionsPRO scores remained stable throughout EV treatment, further supporting the overall value of EV in the treatment of patients with LA/mUC. The potential benefit of EV therapy on overall HRQoL and symptoms such as pain and fatigue is currently being explored. PATIENT SUMMARY: In this study of adult patients with advanced cancer of the urinary tract that progressed after previous medications, quality of life, ability to function, and symptoms did not worsen on treatment with enfortumab vedotin, which is an antibody + drug combination. Some improvements in pain and fatigue were reported by patients, but further research needs to be conducted. These data complement the efficacy and safety data from the EV-201 trial.
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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.