Evidence map›Paper›PMID 42619566›Full record

ArticleInternational journal of urology : official journal of the Japanese Urological Association2026

Efficacy and Safety of Enfortumab Vedotin by Trial Eligibility in Advanced Urothelial Carcinoma: A Multicenter Real-World Study.

Naoto Wakita, Takuto Hara, Taisuke Tobe, Hideto Ueki, Kotaro Suzuki, Tomoaki Terakawa, Jun Teishima, Hideaki Miyake

Abstract readMulticenter Study
In one paragraph

Article in International journal of urology : official journal of the Japanese Urological Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Naoto WakitaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0009-0007-1353-7789
Takuto HaraDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0000-0003-4524-2815
Taisuke TobeDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Hideto UekiDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0000-0002-7742-4528
Kotaro SuzukiDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0000-0003-4589-9251
Tomoaki TerakawaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0000-0002-4447-6516
Jun TeishimaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.ORCID https://orcid.org/0009-0004-7018-5095
Hideaki MiyakeDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesEnfortumab vedotin (EV) has shown survival benefits in advanced urothelial carcinoma (UC). However, patients with severe renal impairment, poor performance status, or anemia were excluded from pivotal trials. Evidence regarding real-world outcomes of EV in trial-ineligible populations remains limited.

methodsWe retrospectively investigated 180 patients with advanced UC treated with EV between December 2021 and December 2024 at Kobe University Hospital or affiliated institutions. Patients were classified as trial-eligible or trial-ineligible using modified EV-301 eligibility criteria based on three factors: estimated glomerular filtration rate < 30 mL/min/1.73 m

resultsThe median age was 73 years, and 73.3% of the patients were male. Eighty-two patients (45.6%) were trial-ineligible. Median PFS (8.0 vs. 5.0 months, p = 0.005) and OS (17.9 vs. 10.5 months, p = 0.001) were significantly longer in trial-eligible patients. ORR was also higher in the trial-eligible group (55.1% vs. 31.7%, p = 0.003). The incidence of all-grade and grade ≥ 3 adverse events was comparable. Subgroup analyses demonstrated significantly poorer PFS and OS in patients with Eastern Cooperative Oncology Group performance status ≥ 2 or hemoglobin < 9 g/dL. Outcomes did not differ according to renal function.

conclusionsClinical outcomes following EV were poorer in trial-ineligible patients than in trial-eligible patients, while safety was comparable between the groups. Poor performance status and anemia were associated with worse survival outcomes, whereas severe renal impairment was not significantly associated with survival outcomes.

Indexed as

Antibodies, MonoclonalCarcinoma, Transitional CellUrinary Bladder NeoplasmsAgedAged, 80 and overFemaleGlomerular Filtration RateHumansMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesTreatment OutcomeAntibodies, Monoclonalenfortumab vedotinanemiaEnfortumab vedotinglomerular filtration ratekidneyurinary bladder neoplasms

Identifiers

PMID42619566
PMCPMC13490996

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Registered trials

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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.