PMID- 35200579 OWN - NLM STAT- MEDLINE DCOM- 20220324 LR - 20220324 IS - 1718-7729 (Electronic) IS - 1198-0052 (Print) IS - 1198-0052 (Linking) VI - 29 IP - 2 DP - 2022 Feb 10 TI - Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study. PG - 945-955 LID - 10.3390/curroncol29020080 [doi] AB - 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. FAU - Dang, Elodie AU - Dang E AD - Pharmacy Department, Foch Hospital, 92150 Suresnes, France. FAU - Vallee, Alexandre AU - Vallee A AD - Clinical Research and Innovation Department, Foch Hospital, 92150 Suresnes, France. FAU - Lepage-Seydoux, Coralie AU - Lepage-Seydoux C AD - Pharmacy Department, Foch Hospital, 92150 Suresnes, France. FAU - Sejean, Karine AU - Sejean K AD - Pharmacy Department, Foch Hospital, 92150 Suresnes, France. FAU - Bonan, Brigitte AU - Bonan B AD - Pharmacy Department, Foch Hospital, 92150 Suresnes, France. FAU - Abraham, Christine AU - Abraham C AD - Medical Oncology Department, Foch Hospital, 92150 Suresnes, France. FAU - Beuzeboc, Philippe AU - Beuzeboc P AD - Medical Oncology Department, Foch Hospital, 92150 Suresnes, France. FAU - Ratta, Raffaele AU - Ratta R AUID- ORCID: 0000-0002-2445-415X AD - Medical Oncology Department, Foch Hospital, 92150 Suresnes, France. LA - eng PT - Journal Article PT - Observational Study DEP - 20220210 PL - Switzerland TA - Curr Oncol JT - Current oncology (Toronto, Ont.) JID - 9502503 RN - 0 (Antibodies, Monoclonal, Humanized) RN - DPT0O3T46P (pembrolizumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - *Carcinoma, Transitional Cell/drug therapy/pathology MH - Humans MH - Retrospective Studies MH - *Urinary Bladder Neoplasms/drug therapy PMC - PMC8870973 OTO - NOTNLM OT - immune checkpoint inhibitors OT - immunotherapy OT - pembrolizumab OT - programmed cell death 1 receptor OT - urinary bladder neoplasms COIS- The authors declare no conflict of interest. EDAT- 2022/02/25 06:00 MHDA- 2022/03/25 06:00 PMCR- 2022/02/10 CRDT- 2022/02/24 12:20 PHST- 2022/01/11 00:00 [received] PHST- 2022/01/31 00:00 [revised] PHST- 2022/02/08 00:00 [accepted] PHST- 2022/02/24 12:20 [entrez] PHST- 2022/02/25 06:00 [pubmed] PHST- 2022/03/25 06:00 [medline] PHST- 2022/02/10 00:00 [pmc-release] AID - curroncol29020080 [pii] AID - curroncol-29-00080 [pii] AID - 10.3390/curroncol29020080 [doi] PST - epublish SO - Curr Oncol. 2022 Feb 10;29(2):945-955. doi: 10.3390/curroncol29020080.