Evidence map›Paper›PMID 37248424›Full record

ArticleCancer immunology, immunotherapy : CII2023

Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study.

Matteo Santoni, Zin W Myint, Thomas Büttner, Hideki Takeshita, Yohei Okada, Elaine T Lam, Danielle Gilbert, Zsófia Küronya, Deniz Tural, Renate Pichler and 33 more

Open access · greenAbstract read
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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  3. Bioinformatics analysis and clinical validation identifyTranslational andrology and urology · 2026
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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

43 authors at 20 institutions in 17 countries.

Matteo SantoniOncology Unit, Macerata Hospital, Via Santa Lucia 2, 62100, Macerata, Italy. mattymo@alice.it.
Zin W MyintMarkey Cancer Center, University of Kentucky, Lexington, KY, 40536-0293, USA.
Thomas BüttnerDepartment of Urology, University Hospital Bonn (UKB), 53127, Bonn, Germany.
Hideki TakeshitaDepartment of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Yohei OkadaDepartment of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Elaine T LamUniversity of Colorado Cancer Center, Anschutz Medical Campus, Aurora, CO, USA.
Danielle GilbertUniversity of Colorado Cancer Center, Anschutz Medical Campus, Aurora, CO, USA.
Zsófia KüronyaDepartment of Genitourinary Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary.
Deniz TuralDepartment of Medical Oncology, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Zuhuratbaba District, Tevfik Saglam St. No: 11, Bakirkoy, Istanbul, Turkey.
Renate PichlerDepartment of Urology, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.
Enrique GrandeDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Simon J CrabbSouthampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK.
Robert KempSouthampton Experimental Cancer Medicine Centre, University of Southampton, Southampton, UK.
Francesco MassariMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Via Albertoni - 15, Bologna, Italy.
Sarah ScagliariniUOC di Oncologia, Azienda Ospedaliera di Rilievo Nazionale Cardarelli di Napoli, Naples, Italy.
Roberto IacovelliOncologia Medica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Nuno VauUrologic Oncology, Champalimaud Clinical Center, 1400-038, Lisbon, Portugal.
Umberto BassoMedical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padua, Italy.
Marco MaruzzoMedical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, 35128, Padua, Italy.
Javier Molina-CerrilloDepartment of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
Luca GalliOncology Unit 2, University Hospital of Pisa, 56126, Pisa, Italy.
Aristotelis Bamias2nd Propaedeutic Department of Internal Medicine, School of Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Ugo De GiorgiDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Paolo Andrea ZucaliDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Mimma RizzoDivision of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
Emmanuel SerontDepartment of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint Paul, Belgium.
Lazar PopovicOncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia.
Orazio CaffoMedical Oncology Unit, Santa Chiara Hospital, Trento, Italy.
Sebastiano ButiMedical Oncology Unit, Department of Medicine and Surgery, University Hospital of Parma, University of Parma, Parma, Italy.
Ravindran KanesvaranDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Jindrich KopeckyDepartment of Clinical Oncology and Radiotherapy, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
Jakub KucharzDepartment of Uro-Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Annalisa ZeppelliniNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Ondřej FialaDepartment of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen, Charles University, Pilsen, Czech Republic.
Johannes LandmesserKlinik für Urologie, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Jawaher AnsariMedical Oncology, Tawam Hospital, Al Ain, United Arab Emirates.
Patrizia GiannatempoDipartimento di Oncologia Medica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Alessandro RizzoStruttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico Globale del Paziente Oncologico "Don Tonino Bello", I.R.C.C.S. Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Ignacio Ortego ZabalzaDepartment of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain.
Fernando Sabino M MonteiroLatin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
Nicola BattelliOncology Unit, Macerata Hospital, Via Santa Lucia 2, 62100, Macerata, Italy.
Fabio CalabròDepartment of Oncology, San Camillo Forlanini Hospital, Rome, Italy.
Camillo PortaDivision of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
Istituto Oncologico Veneto · ITMD Anderson Cancer Center Madrid · ESNIHR CRUK Experimental Cancer Medicine Centre · GBOspedale di MacerataSocial Insurance Saitama Chuo Hospital · JPUniversity of Colorado Cancer Center · USAgostino Gemelli University Polyclinic · ITAzienda di Rilievo Nazionale ed Alta Specializzazione · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITAzienda USL di Bologna · ITBakırköy Dr.Sadi Konuk Eğitim ve Araştırma Hastanesi · TRCarlo Forlanini Hospital · ITChampalimaud Foundation · PTCharles University · CZFondazione IRCCS Istituto Nazionale dei Tumori · ITHôpital de Jolimont · BEHospital Universitario Ramón y Cajal · ESHumanitas University · ITInnsbruck Medical University · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.

methodsData from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.

resultsOur analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.

conclusionsOur data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCisplatinFemaleHumansMaleAntibodies, Monoclonal, HumanizedCisplatinpembrolizumabARON-2 studyImmunotherapyNCT05290038PembrolizumabReal-world dataUrothelial cancer

Identifiers

PMID37248424
PMCPMC10991859
OpenAlexW4378649910

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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.