Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting

(1) Background Immune checkpoint inhibitors (ICIs) have recently become an important therapeutic option for patients with advanced urothelial carcinoma (aUC). Avelumab is an anti-PD-L1 (programmed cell death ligand 1) antibody that restores antitumor T-cell immune function by blocking the binding of...

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Main Authors: Rossella De Luca, Pasquale Vitale, Alessio Pepe, Roberta Spedaliere, Alchiede Simonato, Raffaele Addeo, Giuseppe Cicero
Format: Article
Language:English
Published: MDPI AG 2024-11-01
Series:Scientia Pharmaceutica
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Online Access:https://www.mdpi.com/2218-0532/92/4/62
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author Rossella De Luca
Pasquale Vitale
Alessio Pepe
Roberta Spedaliere
Alchiede Simonato
Raffaele Addeo
Giuseppe Cicero
author_facet Rossella De Luca
Pasquale Vitale
Alessio Pepe
Roberta Spedaliere
Alchiede Simonato
Raffaele Addeo
Giuseppe Cicero
author_sort Rossella De Luca
collection DOAJ
description (1) Background Immune checkpoint inhibitors (ICIs) have recently become an important therapeutic option for patients with advanced urothelial carcinoma (aUC). Avelumab is an anti-PD-L1 (programmed cell death ligand 1) antibody that restores antitumor T-cell immune function by blocking the binding of PD-1 to its ligand PD-L1. (2) Methods: Our study enrolled 60 elderly patients (≥70 years) diagnosed with aUC. The primary endpoints of this study were overall survival (OS), progression free survival (PFS), and objective response rate (ORR); the secondary endpoints were tolerability, pre- and post- treatment reduction in serum Ca 19.9, and quality of life (QoL). (3) Results: Our results showed no statistically significant or clinically relevant differences between the PD-L1-positive and negative groups. Avelumab was well tolerated and resulted in good disease control, with a moderate toxicity profile and significant clinical benefit. The median PFS was 3.6 months (95% CI: 2.3–6.8), and the median OS was 18.6 months (95% CI: 6.3–20.7), with an ORR of 20%. A significant correlation was observed between serum Ca 19.9 reduction and PFS of 0.59 (95% CI: 0.12–0.57), <i>p</i> = 0.007. (4) Conclusions: Avelumab is an immunotherapy treatment that has been shown to be an effective and well tolerated treatment option in elderly patients with aUC.
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spelling doaj-art-40cdc7320ca64a36b0c1ced671a289ea2025-08-20T02:01:23ZengMDPI AGScientia Pharmaceutica0036-87092218-05322024-11-019246210.3390/scipharm92040062Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life SettingRossella De Luca0Pasquale Vitale1Alessio Pepe2Roberta Spedaliere3Alchiede Simonato4Raffaele Addeo5Giuseppe Cicero6UOC Medical Oncology, AOUP “P. Giaccone”, Palermo 90127, ItalyHospital San Giovanni di Dio, Medical Oncology Unit, Frattamaggiore, Napoli 80027, ItalyARNAS Hospital Civico Di Cristina Benfratelli, Medical Oncology Unit, Palermo 90127, ItalyHospital San Giovanni di Dio, Medical Oncology Unit, Frattamaggiore, Napoli 80027, ItalyDepartment of Precision Medicine in Medical, Surgical and Critical Areas, University of Palermo, Palermo 90127, ItalyHospital San Giovanni di Dio, Medical Oncology Unit, Frattamaggiore, Napoli 80027, ItalyDepartment of Precision Medicine in Medical, Surgical and Critical Areas, University of Palermo, Palermo 90127, Italy(1) Background Immune checkpoint inhibitors (ICIs) have recently become an important therapeutic option for patients with advanced urothelial carcinoma (aUC). Avelumab is an anti-PD-L1 (programmed cell death ligand 1) antibody that restores antitumor T-cell immune function by blocking the binding of PD-1 to its ligand PD-L1. (2) Methods: Our study enrolled 60 elderly patients (≥70 years) diagnosed with aUC. The primary endpoints of this study were overall survival (OS), progression free survival (PFS), and objective response rate (ORR); the secondary endpoints were tolerability, pre- and post- treatment reduction in serum Ca 19.9, and quality of life (QoL). (3) Results: Our results showed no statistically significant or clinically relevant differences between the PD-L1-positive and negative groups. Avelumab was well tolerated and resulted in good disease control, with a moderate toxicity profile and significant clinical benefit. The median PFS was 3.6 months (95% CI: 2.3–6.8), and the median OS was 18.6 months (95% CI: 6.3–20.7), with an ORR of 20%. A significant correlation was observed between serum Ca 19.9 reduction and PFS of 0.59 (95% CI: 0.12–0.57), <i>p</i> = 0.007. (4) Conclusions: Avelumab is an immunotherapy treatment that has been shown to be an effective and well tolerated treatment option in elderly patients with aUC.https://www.mdpi.com/2218-0532/92/4/62Avelumabimmunotherapyadvanced urothelial carcinomaprogression free survivalquality of life
spellingShingle Rossella De Luca
Pasquale Vitale
Alessio Pepe
Roberta Spedaliere
Alchiede Simonato
Raffaele Addeo
Giuseppe Cicero
Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
Scientia Pharmaceutica
Avelumab
immunotherapy
advanced urothelial carcinoma
progression free survival
quality of life
title Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
title_full Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
title_fullStr Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
title_full_unstemmed Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
title_short Avelumab in First Line Maintenance in Advanced Urothelial Carcinoma (aUC) in Elderly Patients: Efficacy, Tolerability, and Quality of Life in Real Life Setting
title_sort avelumab in first line maintenance in advanced urothelial carcinoma auc in elderly patients efficacy tolerability and quality of life in real life setting
topic Avelumab
immunotherapy
advanced urothelial carcinoma
progression free survival
quality of life
url https://www.mdpi.com/2218-0532/92/4/62
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