Evidence map›Paper›PMID 41031719›Full record

ArticleCancer medicine2025

Treatment-Related Adverse Events and Associated Outcomes in Patients With Advanced Urothelial Carcinoma Treated With Enfortumab Vedotin: Analysis of the UNITE Study.

Amanda Nizam, Charles B Nguyen, Jinju Li, Emily C Zabor, Pavlos Msaouel, Cindy Y Jiang, Omar Alhalabi, Eugene Oh, Matthew P Davidsohn, Ilana B Epstein and 29 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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

39 authors.

Amanda NizamDepartment of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.ORCID https://orcid.org/0000-0001-5181-490X
Charles B NguyenDepartment of Hematology and Oncology, University of Michigan Rogel Comprehensive Cancer Center, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-1898-5501
Jinju LiDepartment of Biostatistics, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Emily C ZaborDepartment of Quantitative Health Sciences, Cleveland Clinic Lerner Research Institute, Cleveland, Ohio, USA.ORCID https://orcid.org/0000-0002-1402-4498
Pavlos MsaouelDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0001-6505-8308
Cindy Y JiangDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-2459-1875
Omar AlhalabiDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9658-2206
Eugene OhDepartment of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0003-4125-603X
Matthew P DavidsohnGenitourinary Oncology Program, Dana-Farber Cancer Institute-IMIM Research Lab, Boston, Massachusetts, USA.ORCID https://orcid.org/0009-0000-1480-9423
Ilana B EpsteinGenitourinary Oncology Program, Dana-Farber Cancer Institute-IMIM Research Lab, Boston, Massachusetts, USA.ORCID https://orcid.org/0009-0003-1085-7817
Dimitra Rafailia BakaloudiDivision of Hematology and Oncology, Department of Medicine, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-1214-7507
Rafee TalukderDivision of Hematology/Oncology, Baylor College of Medicine, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-6619-2573
Tanya JindalDepartment of Hematology/Oncology, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.ORCID https://orcid.org/0000-0001-5954-3278
Amy K TaylorDepartment of Medicine, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.ORCID https://orcid.org/0000-0003-4559-4159
Michael J GloverDivision of Oncology, Stanford University, Stanford, California, USA.ORCID https://orcid.org/0000-0002-9811-9004
Ali Raza KhakiDivision of Oncology, Stanford University, Stanford, California, USA.ORCID https://orcid.org/0000-0002-4655-4426
Emily LemkeDivision of Hematology and Oncology, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Hannah MabeyDepartment of Medicine, Division of Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Bashar AbuqayasDepartment of Medicine, University of Iowa Holden Comprehensive Cancer Center, Iowa City, Iowa, USA.ORCID https://orcid.org/0000-0002-9258-8299
Albert JangDepartment of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.ORCID https://orcid.org/0000-0002-0461-6174
Jason R BrownDepartment of Medicine, Case Western Reserve University/University Hospitals Seidman Cancer Center, Cleveland, Ohio, USA.ORCID https://orcid.org/0000-0001-6225-7555
Sean T EvansDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Cameron PywellDepartment of Medicine, University of Alabama at Birmingham O'neal Comprehensive Cancer Center, Birmingham, Alabama, USA.
Arnab BasuDepartment of Medicine, University of Alabama at Birmingham O'neal Comprehensive Cancer Center, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0002-8678-3880
Mehmet A BilenDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.ORCID https://orcid.org/0000-0003-4003-1103
Pedro C BarataDepartment of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.ORCID https://orcid.org/0000-0002-8890-2951
Yousef ZakhariaDepartment of Medicine, University of Iowa Holden Comprehensive Cancer Center, Iowa City, Iowa, USA.ORCID https://orcid.org/0000-0001-9480-2626
Matthew I MilowskyDepartment of Medicine, Division of Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-8965-8129
Deepak KilariDivision of Hematology and Oncology, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.ORCID https://orcid.org/0000-0002-6999-1901
Christopher J HoimesDepartment of Medicine, Duke Cancer Institute, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0001-8980-2410
Sumit A ShahDivision of Oncology, Stanford University, Stanford, California, USA.ORCID https://orcid.org/0000-0001-9479-2333
Hamid EmamekhooDepartment of Medicine, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.ORCID https://orcid.org/0000-0002-8506-8703
Nancy B DavisDepartment of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID https://orcid.org/0000-0002-7933-2280
Shilpa GuptaDepartment of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.ORCID https://orcid.org/0000-0002-8775-503X
Petros GrivasDivision of Hematology and Oncology, Department of Medicine, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0003-3965-3394
Joaquim BellmuntGenitourinary Oncology Program, Dana-Farber Cancer Institute-IMIM Research Lab, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-2328-3421
Matthew T CampbellDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0003-1915-4491
Ajjai S AlvaDepartment of Hematology and Oncology, University of Michigan Rogel Comprehensive Cancer Center, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-1898-3522
Vadim S KoshkinDepartment of Hematology/Oncology, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.ORCID https://orcid.org/0000-0003-2277-8668

Funding

TRAINING IN CANCER BIOLOGY &TRANSPLANTATIONT32CA009515 · NCI · UNIVERSITY OF WASHINGTON · PI NANCY ELLEN DAVIDSON, Effie W Petersdorf · 1985 to 2026
$16.2M
NCI NIH HHS T32 CA009515
6 · The paper itself

Abstract

introductionEnfortumab vedotin-ejfv (EV), an antibody-drug conjugate approved for advanced urothelial carcinoma (aUC), has limited real-world safety data and no validated predictive biomarkers. Retrospective studies suggest higher objective response rates (ORR) among patients developing EV-related dermatologic toxicities, but survival implications remain unclear. This analysis assessed the safety of EV monotherapy and the impact of dermatologic and neurologic toxicities on efficacy outcomes in a multi-institutional cohort. MATERIALS AND

methodsUNITE is a multicenter, retrospective study across 16 US sites of patients with aUC treated with targeted agents, including EV. Primary endpoints were the incidence of EV treatment-related adverse events (TRAEs, any grade) and TRAE-related treatment modifications. Secondary endpoints included a comparison of ORR, progression-free survival (PFS), and overall survival (OS) between patients with and without dermatologic toxicities and neuropathy. To reduce immortal time bias, Cox regression models incorporated TRAEs as time-dependent covariates to adjust for EV treatment duration as well as Eastern Cooperative Oncology Group performance status (ECOG PS), hemoglobin, and liver metastases.

resultsBetween 2018 and 2023, 485 patients with aUC received > 1 dose of EV monotherapy. Most (67%) received > 2 prior therapy lines. Any grade TRAEs occurred in 77%, most frequently neuropathy (36%) and dermatologic toxicities (27%); 57% required treatment modification and 21% discontinued EV, primarily due to neuropathy (9%) and fatigue (3%). Patients with dermatologic toxicities and neuropathy had higher ORR (56% vs. 42%; p = 0.007 and 64% vs. 35%; p < 0.0001, respectively). Neuropathy was independently associated with improved OS (HR 0.66; 95% CI 0.50-0.87; p = 0.002); dermatologic TRAEs were not associated with PFS or OS benefit.

conclusionsEV safety outside clinical trials was consistent with prior reports, with no new signals. Treatment modifications were most often due to neuropathy, dermatologic toxicities, and fatigue. Both dermatologic toxicities and neuropathy correlated with higher ORR, but only neuropathy was independently associated with improved OS.

Indexed as

Antibodies, MonoclonalAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellImmunoconjugatesUrinary Bladder NeoplasmsUrologic NeoplasmsAgedAged, 80 and overFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAntibodies, MonoclonalAntineoplastic Agents, Immunologicalenfortumab vedotinImmunoconjugatesadverse eventsantibody–drug conjugatesenfortumab vedotintreatment‐related toxicityurothelial carcinoma

Identifiers

PMID41031719
PMCPMC12486332

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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.