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

J 2024

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

RIZZO, Alessandro, Fernando Sabino Marques MONTEIRO, Yueksel URUN, Francesco MASSARI, Se Hoon PARK et. al.

Basic information

Original name

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

Authors

Edition

Targeted Oncology, Dordrecht, Springer, 2024, 1776-2596

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

Netherlands

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.400 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1007/s11523-024-01089-2

UT WoS

001285240300001

Keywords in English

Advanced Urothelial Carcinoma; Pembrolizumab

Abstract

V originále

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.

Citovat

RIZZO, Alessandro, Fernando Sabino Marques MONTEIRO, Yueksel URUN, Francesco MASSARI, Se Hoon PARK, Maria T BOURLON, Alexandr POPRACH, Mimma RIZZO, Hideki TAKESHITA, Patrizia GIANNATEMPO, Andrey SOARES, Giandomenico ROVIELLO, Javier MOLINA-CERRILLO, Francesco CARROZZA, Halima ABAHSSAIN, Carlo MESSINA, Ray Manneh KOPP, Renate PICHLER, Luigi FORMISANO, Deniz TURAL, Francesco ATZORI, Fabio CALABRO, Ravindran KANESVARAN, Sebastiano BUTI and Matteo SANTONI. Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project. Targeted Oncology. Dordrecht: Springer, 2024, 9 pp. ISSN 1776-2596. Available from: https://dx.doi.org/10.1007/s11523-024-01089-2.

@article{2423138,
   author = {Rizzo, Alessandro and Monteiro, Fernando Sabino Marques and Urun, Yueksel and Massari, Francesco and Park, Se Hoon and Bourlon, Maria T and Poprach, Alexandr and Rizzo, Mimma and Takeshita, Hideki and Giannatempo, Patrizia and Soares, Andrey and Roviello, Giandomenico and MolinaandCerrillo, Javier and Carrozza, Francesco and Abahssain, Halima and Messina, Carlo and Kopp, Ray Manneh and Pichler, Renate and Formisano, Luigi and Tural, Deniz and Atzori, Francesco and Calabro, Fabio and Kanesvaran, Ravindran and Buti, Sebastiano and Santoni, Matteo},
   article_location = {Dordrecht},
   doi = {http://dx.doi.org/10.1007/s11523-024-01089-2},
   keywords = {Advanced Urothelial Carcinoma; Pembrolizumab},
   language = {eng},
   issn = {1776-2596},
   journal = {Targeted Oncology},
   title = {Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project},
   url = {https://link.springer.com/article/10.1007/s11523-024-01089-2},
   year = {2024}
}

TY  - JOUR
ID  - 2423138
AU  - Rizzo, Alessandro - Monteiro, Fernando Sabino Marques - Urun, Yueksel - Massari, Francesco - Park, Se Hoon - Bourlon, Maria T - Poprach, Alexandr - Rizzo, Mimma - Takeshita, Hideki - Giannatempo, Patrizia - Soares, Andrey - Roviello, Giandomenico - Molina-Cerrillo, Javier - Carrozza, Francesco - Abahssain, Halima - Messina, Carlo - Kopp, Ray Manneh - Pichler, Renate - Formisano, Luigi - Tural, Deniz - Atzori, Francesco - Calabro, Fabio - Kanesvaran, Ravindran - Buti, Sebastiano - Santoni, Matteo
PY  - 2024
TI  - Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project
JF  - Targeted Oncology
PB  - Springer
SN  - 17762596
KW  - Advanced Urothelial Carcinoma
KW  - Pembrolizumab
UR  - https://link.springer.com/article/10.1007/s11523-024-01089-2
N2  - 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.
ER  -

RIZZO, Alessandro, Fernando Sabino Marques MONTEIRO, Yueksel URUN, Francesco MASSARI, Se Hoon PARK, Maria T BOURLON, Alexandr POPRACH, Mimma RIZZO, Hideki TAKESHITA, Patrizia GIANNATEMPO, Andrey SOARES, Giandomenico ROVIELLO, Javier MOLINA-CERRILLO, Francesco CARROZZA, Halima ABAHSSAIN, Carlo MESSINA, Ray Manneh KOPP, Renate PICHLER, Luigi FORMISANO, Deniz TURAL, Francesco ATZORI, Fabio CALABRO, Ravindran KANESVARAN, Sebastiano BUTI and Matteo SANTONI. Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project. \textit{Targeted Oncology}. Dordrecht: Springer, 2024, 9 pp. ISSN~1776-2596. Available from: https://dx.doi.org/10.1007/s11523-024-01089-2.

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