Effectiveness and safety profile of pembrolizumab for metastatic urothelial cancer: A retrospective single-center analysis in Japan.
Aged
Antibodies, Monoclonal, Humanized
/ therapeutic use
Carcinoma, Transitional Cell
/ drug therapy
Female
Follow-Up Studies
Humans
Immune Checkpoint Inhibitors
/ therapeutic use
Liver Neoplasms
/ drug therapy
Lymphatic Metastasis
Male
Middle Aged
Prognosis
Retrospective Studies
Survival Rate
Urinary Bladder Neoplasms
/ drug therapy
immune checkpoint inhibitor
immune-related adverse events
pembrolizumab
prognostic factor
urothelial carcinoma
Journal
Cancer reports (Hoboken, N.J.)
ISSN: 2573-8348
Titre abrégé: Cancer Rep (Hoboken)
Pays: United States
ID NLM: 101747728
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
revised:
03
03
2021
received:
07
01
2021
accepted:
25
03
2021
pubmed:
3
5
2021
medline:
8
3
2022
entrez:
2
5
2021
Statut:
ppublish
Résumé
The paradigm of medical treatment for metastatic urothelial carcinoma is dramatically changing through the introduction of pembrolizumab. We investigated the treatment effectiveness, the safety profile, and the prognostic factors of pembrolizumab in Japanese real-world clinical practice. The medical records of 74 consecutive Japanese patients with metastatic urothelial cancer (UC), who started pembrolizumab as a second- or later-line treatment at our institution between January 2018 and March 2020, were reviewed and statistically analyzed. The median follow-up period after initiation of pembrolizumab was 8.5 (interquartile range: 3.5-15.7) months. The objective response rate was 30.2%, the median progression-free survival period was 4.9 months, and the median overall survival (OS) period was 13.3 months. Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), among whom eight patients (10.9%) had severe AEs (grade 3 or more), including grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the presence of liver metastasis, worse performance status (≥2), elevated serum lactate dehydrogenase, and increased C-reactive protein were predictive of shorter OS. We studied the effectiveness and safety profile of pembrolizumab therapy in Japanese UC patients. We believe that the data presented here will be useful for clinical physicians.
Sections du résumé
BACKGROUND
The paradigm of medical treatment for metastatic urothelial carcinoma is dramatically changing through the introduction of pembrolizumab.
AIM
We investigated the treatment effectiveness, the safety profile, and the prognostic factors of pembrolizumab in Japanese real-world clinical practice.
METHODS AND RESULTS
The medical records of 74 consecutive Japanese patients with metastatic urothelial cancer (UC), who started pembrolizumab as a second- or later-line treatment at our institution between January 2018 and March 2020, were reviewed and statistically analyzed. The median follow-up period after initiation of pembrolizumab was 8.5 (interquartile range: 3.5-15.7) months. The objective response rate was 30.2%, the median progression-free survival period was 4.9 months, and the median overall survival (OS) period was 13.3 months. Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), among whom eight patients (10.9%) had severe AEs (grade 3 or more), including grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the presence of liver metastasis, worse performance status (≥2), elevated serum lactate dehydrogenase, and increased C-reactive protein were predictive of shorter OS.
CONCLUSION
We studied the effectiveness and safety profile of pembrolizumab therapy in Japanese UC patients. We believe that the data presented here will be useful for clinical physicians.
Identifiants
pubmed: 33934570
doi: 10.1002/cnr2.1398
pmc: PMC8714548
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immune Checkpoint Inhibitors
0
pembrolizumab
DPT0O3T46P
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1398Subventions
Organisme : Smoking Research Foundation
ID : 16K11035
Informations de copyright
© 2021 The Authors. Cancer Reports published by Wiley Periodicals LLC.
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