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Observational Study
. 2022 Feb 10;29(2):945-955.
doi: 10.3390/curroncol29020080.

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

Elodie Dang  1 , Alexandre Vallée  2 , Coralie Lepage-Seydoux  1 , Karine Sejean  1 , Brigitte Bonan  1 , Christine Abraham  3 , Philippe Beuzeboc  3 , Raffaele Ratta  3
Affiliations
Observational Study

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

Elodie Dang et al. Curr Oncol. .

Abstract

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.

Keywords: immune checkpoint inhibitors; immunotherapy; pembrolizumab; programmed cell death 1 receptor; urinary bladder neoplasms.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan–Meyer estimates of overall survival in months in the studied population.
Figure 2
Figure 2
Kaplan–Meyer estimates of Progression-free survival in months in the studied population.
See this image and copyright information in PMC

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