Evidence map›Paper›PMID 41647344›Full record

ArticleESMO real world data and digital oncology2025

Incidence, risk factors, and clinical implications of enfortumab vedotin-related cutaneous toxicity in urothelial carcinoma: a large-scale, real-world study in Japan.

Y Kita, T Hara, T Kawahara, K Hashimoto, Y Matsushita, H Ito, T Abe, A Igarashi, S Shimura, T Sazuka and 30 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO real world data and digital oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Observational
  3. 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

40 authors.

Y KitaDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
T HaraDepartment of Urology, Kobe University, Kobe, Japan.
T KawaharaDepartment of Urology, University of Tsukuba, Tsukuba, Japan.
K HashimotoDepartment of Urology, Sapporo Medical University, Sapporo, Japan.
Y MatsushitaDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
H ItoDepartment of Urology, Yokohama City University, Yokohama, Japan.
T AbeDepartment of Urology, Hokkaido University, Sapporo, Japan.
A IgarashiDepartment of Urology, Kobe City Medical Center General Hospital, Kobe, Japan.
S ShimuraDepartment of Urology, Kitasato University, Kanagawa, Japan.
T SazukaDepartment of Urology, Chiba University, Chiba, Japan.
A YokomizoDepartment of Urology, Harasanshin Hospital, Fukuoka, Japan.
N TakaokaDepartment of Urology, Tenri Hospital, Tenri, Japan.
M KatoDepartment of Urology, Osaka Metropolitan University, Osaka, Japan.
T HazamaDepartment of Urology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.
M MiyakeDepartment of Urology, Nara Medical University, Nara, Japan.
Y SuginoDepartment of Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, Tsu, Japan.
J MutaguchiDepartment of Urology, Kyushu University, Fukuoka, Japan.
A TakahashiDepartment of Urology, Hakodate Goryoukaku Hospital, Hakodate, Japan.
Y ShiraishiDepartment of Urology, Shizuoka General Hospital, Shizuoka, Japan.
S TataranoDepartment of Urology, Kagoshima University, Kagoshima, Japan.
Y TakaiDepartment of Urology, Yamagata University, Tsuruoka, Japan.
T MochizukiDepartment of Urology, University of Yamanashi, Chuo, Japan.
S NakanishiDepartment of Urology, University of the Ryukyus, Nakagami, Japan.
K MoriDepartment of Urology, Jikei University School of Medicine, Tokyo, Japan.
T YoshidaDepartment of Urology, Shiga General Hospital, Moriyama, Japan.
T HayashiDepartment of Urology, Hiroshima University, Hiroshima, Japan.
H OtsukaDepartment of Urology, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan.
T AnamiDepartment of Urology, Kumamoto University, Kumamoto, Japan.
K OkashoDepartment of Urology, Hirakata Kohsai Hospital, Hirakata, Japan.
K DaizumotoDepartment of Urology, Tokushima University, Tokushima, Japan.
M KobayashiDepartment of Urology, Akita University, Akita, Japan.
I KobayashiDepartment of Urology, Aichi Medical University, Nagakute, Japan.
J WatanabeDepartment of Urology, Toyooka Hospital, Toyooka, Japan.
N NishiyamaDepartment of Urology, University of Toyama, Toyama, Japan.
T ShibuyaDepartment of Urology, Oita University, Yufu, Japan.
Y MatsuiDepartment of Urology, National Cancer Center Hospital, Tokyo, Japan.
H NishiyamaDepartment of Urology, University of Tsukuba, Tsukuba, Japan.
H KitamuraDepartment of Urology, University of Toyama, Toyama, Japan.
T KobayashiDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Japan Urological Oncology Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Enfortumab vedotin (EV), an innovative antibody-drug conjugate targeting Nectin-4, has emerged as a breakthrough therapy for locally advanced or metastatic urothelial carcinoma (la/mUC). However, EV-related cutaneous toxicity (EVRCT) remains a significant concern because of Nectin-4 expression in skin tissue. This study aimed to understand the incidence, risk factors, and clinical implications of EVRCT, focusing on relationships with treatment efficacy, using one of the largest real-world datasets from a Japanese la/mUC patient cohort. Materials and methods: Data from 207 la/mUC patients treated with EV, mainly as a third-line therapy between 2020 and 2023, were analyzed. Multivariate logistic regression and propensity score matching (PSM) were used to assess the risk factors and impact of EVRCTs on patient overall survival (OS) and progression-free survival (PFS). Results: EVRCTs were observed in 59.9% of patients, with 83% occurring within the first 3 months, defined as early-phase EVRCTs (epEVRCTs). Multivariate analysis identified better Eastern Cooperative Oncology Group performance status (ECOG PS = 0), higher hemoglobin levels (≥11 g/dl), and the standard initial dose (1.25 mg/kg) as significant risk factors for epEVRCTs. Patients with epEVRCTs demonstrated significantly improved PFS and OS compared with those without. Post-PSM analysis confirmed longer OS for patients with epEVRCTs, particularly those with mild (grade 1) toxicities, suggesting that these reactions may be significantly linked to favorable treatment outcomes. Conclusions: Our data suggest that epEVRCTs are common and correlate with better clinical outcomes in la/mUC patients treated with EV, underscoring the importance of proactive EVRCT management to optimize therapeutic benefits.

Indexed as

clinical outcomeEV-related cutaneous toxicityincidencerisk factor

Identifiers

PMID41647344
PMCPMC12836633

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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.