Incidence and Clinical Impact of Inflammatory Fluorodeoxyglucose Positron Emission Tomography Uptake After Neoadjuvant Pembrolizumab in Patients with Organ-confined Bladder Cancer Undergoing Radical Cystectomy.
Immune-related adverse events
Muscle-invasive bladder cancer
Pembrolizumab
Positron emission tomography/computed tomography
Prognosis
Journal
European urology focus
ISSN: 2405-4569
Titre abrégé: Eur Urol Focus
Pays: Netherlands
ID NLM: 101665661
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
27
08
2020
revised:
28
09
2020
accepted:
12
10
2020
pubmed:
12
11
2020
medline:
14
4
2022
entrez:
11
11
2020
Statut:
ppublish
Résumé
Data regarding the incidence and prognostic impact of immune-related imaging changes, assessed by To evaluate the role of PET/CT to visualize the immune-related adverse events (irAEs) following pembrolizumab. From February 2017 to August 2019, in 103 patients with nonmetastatic, clinical T2-4aN0M0 bladder cancer, PET/CT scan was performed before and after neoadjuvant pembrolizumab (N = 206 scans), before radical cystectomy. PET/CT before and after neoadjuvant pembrolizumab, before radical cystectomy. We analyzed the occurrence of irAEs, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, against the development of inflammatory FDG uptake described at PET/CT (irAEs + PET/CT). Logistic regression analyses evaluated the association between irAEs + PET/CT and the pathological response to pembrolizumab. Kaplan-Meier curves tested their association with progression-free survival (PFS) after pembrolizumab and radical cystectomy. Forty patients (39%) developed irAEs + PET/CT in several target organs. The most frequent target organs were the thyroid (N = 18), stomach (N = 14), mediastinal lymph nodes (N = 9), and lung (N = 5). These changes were clinically evident in 18 (45%) and were not associated with the pathological response, neither in terms of complete response (ypT0N0, p = 0.07) nor as downstaging to ypT≤1N0 disease (p = 0.1), although ypT0N0 responses were numerically more frequent in patients with irAEs+ PET/CT (47.5% vs 32%). Furthermore, irAE+ PET/CT events were associated with longer, not statistically significant, 24-mo PFS: 88.3% versus 76.5% (p = 0.5). Our results warrant further validation in larger datasets. We presented unique surrogate data of PET/CT that could help improve our understanding of nonclinically evident effects of ICI administration, especially in patients at the early disease stage. We evaluated the utility of PET/CT to visualize the occurrence of inflammatory changes after pembrolizumab in patients with localized bladder cancer without metastases. After immunotherapy, 39% of the patients developed
Sections du résumé
BACKGROUND
BACKGROUND
Data regarding the incidence and prognostic impact of immune-related imaging changes, assessed by
OBJECTIVE
OBJECTIVE
To evaluate the role of PET/CT to visualize the immune-related adverse events (irAEs) following pembrolizumab.
DESIGN, SETTING, AND PARTICIPANTS
METHODS
From February 2017 to August 2019, in 103 patients with nonmetastatic, clinical T2-4aN0M0 bladder cancer, PET/CT scan was performed before and after neoadjuvant pembrolizumab (N = 206 scans), before radical cystectomy.
INTERVENTION
METHODS
PET/CT before and after neoadjuvant pembrolizumab, before radical cystectomy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
METHODS
We analyzed the occurrence of irAEs, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, against the development of inflammatory FDG uptake described at PET/CT (irAEs + PET/CT). Logistic regression analyses evaluated the association between irAEs + PET/CT and the pathological response to pembrolizumab. Kaplan-Meier curves tested their association with progression-free survival (PFS) after pembrolizumab and radical cystectomy.
RESULTS AND LIMITATIONS
CONCLUSIONS
Forty patients (39%) developed irAEs + PET/CT in several target organs. The most frequent target organs were the thyroid (N = 18), stomach (N = 14), mediastinal lymph nodes (N = 9), and lung (N = 5). These changes were clinically evident in 18 (45%) and were not associated with the pathological response, neither in terms of complete response (ypT0N0, p = 0.07) nor as downstaging to ypT≤1N0 disease (p = 0.1), although ypT0N0 responses were numerically more frequent in patients with irAEs+ PET/CT (47.5% vs 32%). Furthermore, irAE+ PET/CT events were associated with longer, not statistically significant, 24-mo PFS: 88.3% versus 76.5% (p = 0.5). Our results warrant further validation in larger datasets.
CONCLUSIONS
CONCLUSIONS
We presented unique surrogate data of PET/CT that could help improve our understanding of nonclinically evident effects of ICI administration, especially in patients at the early disease stage.
PATIENT SUMMARY
RESULTS
We evaluated the utility of PET/CT to visualize the occurrence of inflammatory changes after pembrolizumab in patients with localized bladder cancer without metastases. After immunotherapy, 39% of the patients developed
Identifiants
pubmed: 33172772
pii: S2405-4569(20)30287-X
doi: 10.1016/j.euf.2020.10.003
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Fluorodeoxyglucose F18
0Z5B2CJX4D
pembrolizumab
DPT0O3T46P
Banques de données
ClinicalTrials.gov
['NCT02736266']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1092-1099Informations de copyright
Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.