Evidence mapPaperPMID 40913633Full record

ArticleClinical & experimental metastasis2025

Prognostic immunotherapy score (PIS) in patients with advanced urothelial carcinoma treated with pembrolizumab: real-world data and validation from ARON-2 dataset.

Alessandro Rizzo, Anas Zayed, Elsa Vitale, Sebastiano Buti, Hideki Takeshita, Simon Crabb, Giandomenico Roviello, Emmanuel Seront, Jose Carlos Tapia, Sarah Scagliarini and 14 more

Abstract readValidation Study
PubMed Publisher
In one paragraph

Article in Clinical & experimental metastasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Bioinformatics analysis and clinical validation identifyTranslational andrology and urology · 2026
    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

24 authors.

Alessandro Rizzo *S.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124, Bari, Italy. rizzo.alessandro179@gmail.com.
Anas Zayed *Department of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Elsa Vitale *Directorate of Health Professions and Nursing, ASL Bari, Bari, Italy.
Sebastiano ButiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Hideki TakeshitaDepartment of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Simon CrabbSchool of Cancer Sciences, University of Southampton, Southampton, UK.
Giandomenico RovielloDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
Emmanuel SerontDepartment of Medical Oncology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Jose Carlos TapiaDepartment of Medical Oncology, Institut d'Investigació Biomèdica Sant Pau, Hospital de La Santa Creu I Sant Pau, Barcelona, Spain.
Sarah ScagliariniDepartment of Medical Oncology, AORN "A. Cardarelli", Naples, Italy.
Lazar PopovicOncology Institute of Vojvodina, Faculty of Medicine, University Novi Sad, Novi Sad, Serbia.
Ray Manneh KoppClinical Oncology, Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia.
Halima AbahssainMedicine and Pharmacy Faculty, Medical Oncology Unit, National Institute of Oncology, Mohamed V University, Rabat, Morocco.
Mimma RizzoMedical Oncology Unit, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, Italy.
Fernando Sabino Marques MonteiroLatin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
Raffaella MassafraScientific Directorate, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Oronzo BrunettiS.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Viale Orazio Flacco 65, 70124, Bari, Italy.
Daniele SantiniDip. Scienze E Biotecnologie Medico-Chirurgiche, Oncologia Medica, Policlinico Umberto 1, Rome, Italy.
Yüksel ÜrünDepartment of Medical Oncology, Faculty of Medicine, Ankara University, 06620, Ankara, Turkey.
Rodolfo MontironiMolecular Medicine and Cell Therapy Foundation, c/o Polytechnic University of the Marche Region, Via Tronto 10, 60126, Ancona, Italy.
Veronica MollicaMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Francesco MassariMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Andrey SoaresLatin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil.
Matteo SantoniMedical Oncology Unit, Macerata Hospital, Macerata, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent years have seen the development and advent of novel combinatorial strategies based on immunotherapy, and immune checkpoint inhibitor (ICI) - based treatment has established itself as a mainstay in the treatment of metastatic urothelial carcinoma (UC). Herein, we aimed to validate the prognostic value of a previously developed score, the Prognostic Immunotherapy Score (PIS), including female sex, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) and liver metastases, in patients treated with pembrolizumab for advanced UC from the ARON-2 dataset. We retrospectively analyzed clinical data from Metastatic UC patients diagnosed at age ≥ 18 years. Patients progressing or recurring after platinum-based therapy were included, and treated with pembrolizumab from January 1st, 2016, to December 31st, 2023, in 68 oncological centers from 21 Countries. The Kaplan-Meier analysis was used to calculate the median follow-up. Cox proportional hazard models were used to compare the multivariable effects on patients' survival and to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). A survival receiver operating characteristic (ROC) analysis was exploited in relation to OS and PFS in patients stratified by the presence of 0, 1 or ≥ 2 risk factors and OS with 0, 1 or ≥ 2 risk factors in patients stratified by age, tumor histology, site and time to metastatic disease. The comparison between subgroups was performed with the Fisher exact test. We included 1040 patients from the ARON-2 dataset. We further stratified patients based on the three previously published risk factors: female sex, ECOG-PS = 2 and liver metastases; 526 patients (51%) had 0 risk factors, 408 patients (39%) had 1 factor and 106 patients (10%) had ≥ 2 risk factors. At univariate and multivariate analyses, bone metastases, synchronous metastatic disease and our PIS model based on female sex, liver metastasis, and poor performance status were significantly associated with both OS and PFS. Our findings validate the PIS as a practical scoring model using sex, ECOG-PS, and liver metastasis to stratify survival outcomes in advanced urothelial carcinoma treated with pembrolizumab, supporting more personalized treatment decisions.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellImmune Checkpoint InhibitorsImmunotherapyLiver NeoplasmsUrologic NeoplasmsAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisRetrospective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorspembrolizumabAdvanced urothelial carcinomaImmunotherapyPembrolizumabPrognostic indexReal worldValidation study

Identifiers

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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.