Evidence map›Paper›PMID 40877170›Full record

ArticleIn vivo (Athens, Greece)

Outcomes of Enfortumab Vedotin Treatment in Patients Ineligible for the EV-301 Trial.

Kazutaka Nakamura, Yuki Kobari, Yudai Ishiyama, Hanae Kondo, Toru Inakawa, Yuki Nemoto, Hironori Fukuda, Kazuhiko Yoshida, Junpei Iizuka, Hiroaki Shimmura and 5 more

Abstract readMulticenter Study
In one paragraph

Article in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Efficacy and Safety of Enfortumab Vedotin by Trial Eligibility in Advanced Urothelial Carcinoma: A Multicenter Real-World Study.International journal of urology : official journal of the Japanese Urological Association · 2026
    Article
  3. Journal of nanobiotechnology · 2026
    Article
  4. Article
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

15 authors.

Kazutaka NakamuraDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Yuki KobariDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan; yuukikobari17@gmail.com.
Yudai IshiyamaDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Hanae KondoDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Toru InakawaDepartment of Urology, Saiseikai Kazo General Hospital, Saitama, Japan.
Yuki NemotoDepartment of Urology, Tokiwakai Jyoban Hospital, Fukushima, Japan.
Hironori FukudaDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Kazuhiko YoshidaDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Junpei IizukaDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Hiroaki ShimmuraDepartment of Urology, Tokiwakai Jyoban Hospital, Fukushima, Japan.
Hiroshi KobayashiDepartment of Urology, Saiseikai Kazo General Hospital, Saitama, Japan.
Yasunobu HashimotoDepartment of Urology, Saiseikai Kawaguchi General Hospital, Saitama, Japan.
Hideki IshidaDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Tsunenori KondoDepartment of Urology, Tokyo Women's Medical University Adachi Medical Center, Tokyo, Japan.
Toshio TakagiDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimThe EV-301 trial demonstrated the efficacy of enfortumab vedotin (EV) as a third-line treatment for metastatic urothelial carcinoma (mUC), showing significant improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in patients previously treated with platinum-based therapy and immune checkpoint inhibitors. In real-world clinical practice, patients undergoing third-line treatment often have poor baseline health status, leading to the off-label use of EV in populations ineligible for clinical trials. This study aimed to evaluate the treatment outcomes of EV in both EV-301 trial-eligible and -ineligible patients. PATIENTS AND

methodsFifty-eight patients with mUC treated with EV across five Institutions were retrospectively evaluated and stratified based on the EV-301 trial eligibility criteria. Patients with an Eastern Cooperative Oncology Group performance status of ≥2, baseline hemoglobin level of <9 g/dl, creatinine clearance <30 ml/min, or other protocol-defined criteria were analyzed. Treatment outcomes were assessed for both groups.

resultsOf the 58 patients, 33 (56.9%) met the EV-301 trial eligibility criteria. No significant differences were observed in PFS (median: 9.2

conclusionThe findings of this multi-institutional study highlight the feasibility of EV treatment in EV-301 trial-ineligible patients with mUC, supporting its potential applicability in both trial-eligible and -ineligible groups.

Indexed as

Antibodies, MonoclonalAgedAged, 80 and overFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAntibodies, Monoclonalenfortumab vedotinEnfortumab vedotinEV-301 trialineligible patientsreal-world evidenceurothelial carcinoma

Identifiers

PMID40877170
PMCPMC12396074

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.