Evidence mapPaperPMID 39107651Full record

ArticleTargeted oncology2024

Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project.

Alessandro Rizzo, Fernando Sabino Marques Monteiro, Yüksel Ürün, Francesco Massari, Se Hoon Park, Maria T Bourlon, Alexandr Poprach, Mimma Rizzo, Hideki Takeshita, Patrizia Giannatempo and 15 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Targeted oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. 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

25 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.ORCID 0000-0002-5257-8678
Fernando Sabino Marques Monteiro *Hospital Sírio-Libanês, Brasília, DF, Brazil.
Yüksel ÜrünDepartment of Medical Oncology, Faculty of Medicine, Ankara University, 06620, Ankara, Turkey.
Francesco MassariMedical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
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, Mexico City, Mexico.
Alexandr PoprachMasaryk Memorial Cancer Institute, Brno, Czech Republic.
Mimma RizzoMedical Oncology Unit, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, Italy.
Hideki TakeshitaDepartment of Urology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Patrizia GiannatempoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian 1, Milan, Italy.
Andrey SoaresHospital Israelita Albert Einstein, São Paulo, SP, Brazil.
Giandomenico RovielloDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
Javier Molina-CerrilloDepartment of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain.
Francesco CarrozzaDepartment of Oncology and Hematology, Oncology Unit, Santa Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy.
Halima AbahssainMedicine and Pharmacy Faculty, Medical Oncology Unit, National Institute of Oncology, Mohamed V University, Rabat, Morocco.
Carlo MessinaOncology Unit, A.R.N.A.S. Civico, Palermo, Italy.
Ray Manneh KoppClinical Oncology, Sociedad de Oncología y Hematología del Cesar, Valledupar, Colombia.
Renate PichlerDepartment of Urology, Medical University of Innsbruck, Innsbruck, Austria.
Luigi FormisanoDepartment of Medicine and Surgery, Federico II University, Naples, Italy.
Deniz TuralDepartment of Medical Oncology, Bakirköy Dr. SadiKonuk Training and Research Hospital, Istanbul, Türkiye.
Francesco AtzoriUnità di Oncologia Medica, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy.
Fabio CalabròMedical Oncology 1-IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Ravindran KanesvaranDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Sebastiano Buti *Department of Medicine and Surgery, University of Parma, Parma, Italy.
Matteo Santoni *Medical Oncology Unit, Macerata Hospital, Macerata, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe benefit of immune checkpoint inhibitors (ICIs) for poor performance status patients with advanced urothelial carcinoma (UC) remains unknown.

objectiveIn the present sub-analysis of the ARON-2 study, we investigated the role of pembrolizumab for advanced UC patients with ECOG (Eastern Cooperative Oncology Group) performance status (ECOG-PS) 2. PATIENTS AND

methodsPatients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of advanced UC progressing or recurring after platinum-based therapy and treated with pembrolizumab between 1 January 2016 to 1 April 2024 were included. In this sub-analysis we focused on patients with ECOG-PS 2.

resultsWe included 1,040 patients from the ARON-2 dataset; of these, 167 patients (16%) presented an ECOG-PS 2. The median overall survival (OS) was 14.8 months (95% confidence interval (CI) 12.5-16.1) in the overall study population, 18.2 months (95% CI 15.8-22.2) in patients with ECOG-PS 0-1, and 3.7 months (95% CI 3.2-5.2) in subjects with ECOG-PS 2 (p < 0.001). The median progression-free survival (PFS) in the overall study population was 5.3 months (95% CI 4.3-97.1), 6.2 months (95% CI 5.5-97.1) in patients with ECOG-PS 0-1, and 2.8 months (95% CI 2.1-3.4) in patients with ECOG-PS 2. Among the latter, liver metastases and progressive disease during first-line therapy were significant predictors of OS at both univariate and multivariate analyses. For PFS, univariate and multivariate analyses showed a prognostic role for lung metastases, liver metastases, and progressive disease during first-line therapy.

conclusionsThis large real-world evidence study suggests the effectiveness of second-line pembrolizumab for mUC patients with poor performance status. The presence of liver metastases and progressive disease during first-line therapy is associated with worse clinical outcomes and, thus, should be taken into account when making treatment decisions in clinical practice.

Indexed as

Antibodies, Monoclonal, HumanizedAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalFemaleHumansMaleMiddle AgedUrologic NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumab

Identifiers

PMID39107651

What Socratic holds

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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.