Evidence mapPaperPMID 41264480Full record

Observational studyThe oncologist2025

Real-world effectiveness of Avelumab maintenance in advanced urothelial carcinoma: results from the Italian multicenter MALVA study (Meet-URO 25).

Giandomenico Roviello, Elisabetta Gambale, Irene De Gennaro Aquino, Marco Maruzzo, Carlo Messina, Ismaela Anna Vascotto, Virginia Rossi, Davide Bimbatti, Elisa Erbetta, Marco Messina and 21 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The oncologist, 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

31 authors.

Giandomenico RovielloDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Florence 50139, Italy.ORCID 0000-0001-5504-8237
Elisabetta GambaleDepartment of Experimental and Clinical Medicine, University of Florence, Florence 50139, Italy.
Irene De Gennaro AquinoDepartment of Experimental and Clinical Medicine, University of Florence, Florence 50139, Italy.
Marco MaruzzoIstituto Oncologico Veneto, IOV-IRCCS, Padova 50139, Italy.
Carlo MessinaClinical Oncology, Ospedale Arnas Civico, Palermo, Italy.
Ismaela Anna VascottoDepartment of Experimental and Clinical Medicine, University of Florence, Florence 50139, Italy.
Virginia RossiClinical Oncology, Careggi University Hospital, Florence 50139, Italy.
Davide BimbattiIstituto Oncologico Veneto, IOV-IRCCS, Padova 50139, Italy.
Elisa ErbettaIstituto Oncologico Veneto, IOV-IRCCS, Padova 50139, Italy.
Marco MessinaClinical Oncology, Ospedale Arnas Civico, Palermo, Italy.
Alessia MennittoDivision of Oncology, University Hospital Maggiore della Carità, Novara, Italy.
Sara Elena RebuzziMedical Oncology Unit 2, Ospedale Molinette Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Corso Bramante 88, 10126, Torino, Italy.
Cecilia NassoMedical Oncology, Ospedale Santa Corona, 17027 Pietra Ligure, Italy.
Chiara MercinelliMedical Oncology Department, IRCCS San Raffaele Hospital, Milan, Italy.
Brigida Anna MaioranoMedical Oncology Department, IRCCS San Raffaele Hospital, Milan, Italy.
Martina FanelliDepartment of Oncology, University Hospital of Udine, Udine, Italy.
Mariella SorarùOspedale di Camposampiero, U.O. Oncologia, Camposampiero, Italy.
Federico ScolariDepartment of Biomedical, Experimental and Clinical Sciences, University of Florence, Florence, Italy.
Marinella Micol MelaClinical Oncology, Careggi University Hospital, Florence 50139, Italy.
Luca GalliMedical Oncology Unit 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Alessia SalfiMedical Oncology Unit 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Mimma RizzoOncologia Medica Universitaria Azienda Ospedaliera Universitaria Consorziale, Policlinico di Bari piazza Giulio Cesare, 11, 70124, Bari, Italy.
Silvia PuglisiIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Valentina OrlandoDepartment of Oncology, Ospedale Maggiore, Trieste, Italy.
Giuseppe FornariniIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Alessandro RamettaGenitourinary Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Patrizia GiannatempoGenitourinary Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Linda CerboneDepartment of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy.
Laura DoniClinical Oncology, Careggi University Hospital, Florence 50139, Italy.
Serena PillozziDepartment of Experimental and Clinical Medicine, University of Florence, Florence 50139, Italy.
Lorenzo AntonuzzoDepartment of Experimental and Clinical Medicine, University of Florence, Florence 50139, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

importanceAvelumab maintenance therapy improves survival in patients with advanced urothelial carcinoma who respond to first-line platinum-based chemotherapy. However, real-world evidence on its effectiveness and on the prognostic value of baseline clinical factors remains limited.

objectiveTo evaluate the real-world effectiveness of Avelumab maintenance therapy and to identify baseline prognostic factors associated with clinical outcomes.

designMulticenter prospective observational study including a retrospective cohort of patients treated before study initiation.

settingSeveral Italian oncology centers participating between 2021 and 2023.

participantsA total of 251 patients with advanced or metastatic urothelial carcinoma who received Avelumab maintenance therapy after achieving disease control with first-line platinum-based chemotherapy. INTERVENTION(S) OR EXPOSURE(S): Avelumab maintenance therapy administered according to clinical practice. Baseline clinical variables, including ECOG performance status, metastatic sites, and corticosteroid use, were assessed for prognostic significance. MAIN OUTCOME(S) AND MEASURE(S): Primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes included overall response rate (ORR) and disease control rate (DCR). Prognostic factors were evaluated using multivariate Cox regression.

resultsMedian OS was 22.4 months, and median PFS was 7 months. The ORR and DCR were 26.75% and 69.30%, respectively. Independent predictors of worse OS were ECOG ≥1 (HR 1.57), bone metastases (HR 1.88), brain metastases (HR 7.02), and baseline corticosteroid use (HR 2.42). An exploratory prognostic score integrating ECOG status, bone metastases, and steroid use stratified patients into three groups with significantly different outcomes: median OS was 39.9 months (no adverse factors), 14.1 months (one factor), and 8.4 months (two or more factors), with corresponding ORRs of 33.6%, 28.0%, and 6.9%. CONCLUSIONS AND RELEVANCE: In this large real-world cohort, Avelumab maintenance confirmed its effectiveness and safety in advanced urothelial carcinoma. A simple exploratory prognostic score based on ECOG performance status, bone metastases, and baseline corticosteroid use successfully stratified patients by survival outcomes and may support personalized treatment strategies in clinical practice.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Transitional CellUrologic NeoplasmsAdultAgedAged, 80 and overFemaleHumansItalyMaleMiddle AgedPrognosisProspective StudiesRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedavelumabAvelumabimmunotherapyprognostic scoreurothelial cancer

Identifiers

PMID41264480
PMCPMC12680435

What Socratic holds

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LicenceCC BY
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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 Socratic graph.