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Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project
A. Rizzo, FSM. Monteiro, Y. Ürün, F. Massari, SH. Park, MT. Bourlon, A. Poprach, M. Rizzo, H. Takeshita, P. Giannatempo, A. Soares, G. Roviello, J. Molina-Cerrillo, F. Carrozza, H. Abahssain, C. Messina, RM. Kopp, R. Pichler, L. Formisano, D....
Language English Country France
Document type Journal Article, Multicenter Study
NLK
ProQuest Central
from 2006-01-01 to 1 year ago
Medline Complete (EBSCOhost)
from 2006-01-01 to 1 year ago
Nursing & Allied Health Database (ProQuest)
from 2006-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 2006-01-01 to 1 year ago
Family Health Database (ProQuest)
from 2006-01-01 to 1 year ago
- MeSH
- Adult MeSH
- Antibodies, Monoclonal, Humanized * therapeutic use pharmacology MeSH
- Middle Aged MeSH
- Humans MeSH
- Antineoplastic Agents, Immunological therapeutic use pharmacology MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Urologic Neoplasms drug therapy pathology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
BACKGROUND: The benefit of immune checkpoint inhibitors (ICIs) for poor performance status patients with advanced urothelial carcinoma (UC) remains unknown. OBJECTIVE: In 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 METHODS: Patients 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. RESULTS: We 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. CONCLUSIONS: This 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.
Clinical Oncology Sociedad de Oncología y Hematología del Cesar Valledupar Colombia
Department of Medical and Surgical Sciences University of Bologna Bologna Italy
Department of Medical Oncology Bakirköy Dr SadiKonuk Training and Research Hospital Istanbul Türkiye
Department of Medical Oncology Faculty of Medicine Ankara University 06620 Ankara Turkey
Department of Medical Oncology Hospital Ramón y Cajal Madrid Spain
Department of Medicine and Surgery Federico 2 University Naples Italy
Department of Medicine and Surgery University of Parma Parma Italy
Department of Urology Medical University of Innsbruck Innsbruck Austria
Department of Urology Saitama Medical Center Saitama Medical University Saitama Japan
Division of Medical Oncology National Cancer Centre Singapore Singapore Singapore
Escuela de Medicina Universidad Panamericana Mexico City Mexico
Faculty of Medicine Masaryk University Brno Czech Republic
Hospital Israelita Albert Einstein São Paulo SP Brazil
Hospital Sírio Libanês Brasília DF Brazil
Latin American Cooperative Oncology Group LACOG Porto Alegre Brazil
Masaryk Memorial Cancer Institute Brno Czech Republic
Medical Oncology 1 IRCCS Regina Elena National Cancer Institute Rome Italy
Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Medical Oncology Unit Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Italy
Medical Oncology Unit Macerata Hospital Macerata Italy
Medical Oncology Unit University Hospital of Parma Parma Italy
Oncology Unit A R N A S Civico Palermo Italy
Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea
Unità di Oncologia Medica Azienda Ospedaliero Universitaria di Cagliari Cagliari Italy
References provided by Crossref.org
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