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Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study

Background: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study incl...

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Autores principales: Dang, Elodie, Vallée, Alexandre, Lepage-Seydoux, Coralie, Sejean, Karine, Bonan, Brigitte, Abraham, Christine, Beuzeboc, Philippe, Ratta, Raffaele
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870973/
https://www.ncbi.nlm.nih.gov/pubmed/35200579
http://dx.doi.org/10.3390/curroncol29020080
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author Dang, Elodie
Vallée, Alexandre
Lepage-Seydoux, Coralie
Sejean, Karine
Bonan, Brigitte
Abraham, Christine
Beuzeboc, Philippe
Ratta, Raffaele
author_facet Dang, Elodie
Vallée, Alexandre
Lepage-Seydoux, Coralie
Sejean, Karine
Bonan, Brigitte
Abraham, Christine
Beuzeboc, Philippe
Ratta, Raffaele
author_sort Dang, Elodie
collection PubMed
description Background: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study included advanced UC patients treated with pembrolizumab in a single institution in France. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) at 6 months. Secondary endpoints were objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. Results: 78 patients were included in the study. The median OS was 7.3 months (3.8–12.2). The estimated OS rate at 6 months was 61.5% (50.5–72.6). The median PFS was 3.1 months (1.4–7.2). The estimated PFS rate at 6 months was 42.3% (31.1–53.5). The best ORR was 35.9%. The mean DOR was 95.5 days. The DCR was 30.8%. The most common treatment-related adverse events (AEs) of any grade were fatigue (46.2%), diarrhea (11.5%), pruritus (10.3%) and nausea (9.0%). There were no grade 3 AEs that occurred with an incidence of 5% or more. Conclusion: Our results confirmed those of randomized clinical trials concerning the treatment with pembrolizumab in patients with advanced UC that progressed after platinum-based chemotherapy.
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spelling pubmed-88709732022-02-25 Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study Dang, Elodie Vallée, Alexandre Lepage-Seydoux, Coralie Sejean, Karine Bonan, Brigitte Abraham, Christine Beuzeboc, Philippe Ratta, Raffaele Curr Oncol Article Background: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. Methods: This retrospective, observational study included advanced UC patients treated with pembrolizumab in a single institution in France. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) at 6 months. Secondary endpoints were objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. Results: 78 patients were included in the study. The median OS was 7.3 months (3.8–12.2). The estimated OS rate at 6 months was 61.5% (50.5–72.6). The median PFS was 3.1 months (1.4–7.2). The estimated PFS rate at 6 months was 42.3% (31.1–53.5). The best ORR was 35.9%. The mean DOR was 95.5 days. The DCR was 30.8%. The most common treatment-related adverse events (AEs) of any grade were fatigue (46.2%), diarrhea (11.5%), pruritus (10.3%) and nausea (9.0%). There were no grade 3 AEs that occurred with an incidence of 5% or more. Conclusion: Our results confirmed those of randomized clinical trials concerning the treatment with pembrolizumab in patients with advanced UC that progressed after platinum-based chemotherapy. MDPI 2022-02-10 /pmc/articles/PMC8870973/ /pubmed/35200579 http://dx.doi.org/10.3390/curroncol29020080 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Dang, Elodie
Vallée, Alexandre
Lepage-Seydoux, Coralie
Sejean, Karine
Bonan, Brigitte
Abraham, Christine
Beuzeboc, Philippe
Ratta, Raffaele
Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title_full Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title_fullStr Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title_full_unstemmed Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title_short Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study
title_sort clinical benefit of pembrolizumab in advanced urothelial cancer patients in real-life setting: an efficacy and safety monocentric study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870973/
https://www.ncbi.nlm.nih.gov/pubmed/35200579
http://dx.doi.org/10.3390/curroncol29020080
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