Evidence map›Paper›PMID 39980145›Full record

Observational studyCancer medicine2025

Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience.

Mimma Rizzo, Franco Morelli, Yüksel Ürün, Sebastiano Buti, Se Hoon Park, Maria T Bourlon, Enrique Grande, Francesco Massari, Johannes Landmesser, Alexandr Poprach and 15 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05290038 (ARON-2 Study-Multicentric International Retrospective Study), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT05290038 recruitingnot on this map

ARON-2 Study-Multicentric International Retrospective Study

TypeobservationalSponsorMatteo SantoniRan2022 to 2027Enrolled367ConditionsUrothelial Carcinoma
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Observational
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

25 authors.

Mimma RizzoMedical Oncology Unit, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, Italy.ORCID https://orcid.org/0000-0001-7743-741X
Franco MorelliMedical Oncology Unit, IRCCS Casa Sollievo della Sofferenza, Foggia, Italy.
Yüksel ÜrünDepartment of Medical Oncology, Faculty of Medicine, Ankara University, Ankara, Turkey.
Sebastiano ButiDepartment of Medicine and Surgery, University of Parma, Parma, Italy.ORCID https://orcid.org/0000-0003-0876-0226
Se Hoon ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Maria T BourlonDepartment of Hemato-Oncology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Universidad Panamericana, Mexico City, Mexico.ORCID https://orcid.org/0000-0002-3116-912X
Enrique GrandeDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Francesco MassariDepartment of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.
Johannes LandmesserKlinik für Urologie, Universitätsklinikum Schleswig-Holstein Campus Lübeck, Lübeck, Germany.
Alexandr PoprachDepartment of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
Hideki TakeshitaDepartment of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.ORCID https://orcid.org/0000-0002-1512-6904
Giandomenico RovielloDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Florence, Italy.
Zin W MyintDivision of Medical Oncology, Department of Internal Medicine, Markey Cancer Center, University of Kentucky, Lexington, Kentucky, USA.
Lazar PopovicFaculty of Medicine, Oncology Institute of Vojvodina, University of Novi Sad, Novi Sad, Serbia.
Andrey SoaresHospital Israelita Albert Einstein, São Paulo, Brazil.
Halima AbahssainMedicine and Pharmacy Faculty, National Institute of Oncology, Medical Oncology Unit, Mohamed V University, Rabat, Morocco.ORCID https://orcid.org/0000-0002-3109-1609
Patrizia GiannatempoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Javier Molina-CerrilloDepartment of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
Lorena IncorvaiaDepartment of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.), Section of Medical Oncology, University of Palermo, Palermo, Italy.
Samer SalahDepartment of Adult Medical Oncology, King Fahad Specialist Hospital-Dammam, Dammam, Saudi Arabia.ORCID https://orcid.org/0000-0001-7421-2522
Annalisa ZeppelliniNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Fernando Sabino Marques MonteiroLatin American Cooperative Oncology Group-LACOG, Porto Alegre, Brazil.
Camillo PortaChair of Oncology, Interdisciplinary Department of Medicine, University of Bari "Aldo Moro", Bari, Italy.
Shilpa GuptaTaussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Matteo SantoniMedical Oncology Unit, Macerata Hospital, Macerata, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody-drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune-checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real-world analysis comparing the effectiveness of EV to chemotherapy in this setting.

methodsThe data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum-based chemotherapy. Patients were assessed for overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).

resultsOur analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2-10.7) in the overall study population, 13.6 months (95%CI 10.0-31.0) in patients receiving EV and 6.8 months (95%CI 6.0-8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum-based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5-17.0] vs. 3.0 months [95%CI 2.6-3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort.

conclusionsThe results of our international analysis of real-world data confirm the effectiveness of EV in the sequential strategy of aUC patients who have received prior platinum-based chemotherapy and anti-PD-1 pembrolizumab, regardless of commonly considered prognostic factors.

trial registrationClinicalTrials.gov identifier: NCT05290038.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellImmunoconjugatesUrinary Bladder NeoplasmsUrologic NeoplasmsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedenfortumab vedotinImmunoconjugatespembrolizumabARON‐2 studychemotherapyenfortumab vedotinNCT05290038pembrolizumabreal‐world datasequencingurothelial carcinoma

Identifiers

PMID39980145
PMCPMC11842279

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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.