Surrogate Endpoints as Predictors of Overall Survival in Metastatic Urothelial Cancer: A Trial-level Analysis.
Bladder cancer
Clinical trials
Surrogate endpoints
Journal
European urology open science
ISSN: 2666-1683
Titre abrégé: Eur Urol Open Sci
Pays: Netherlands
ID NLM: 101771568
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
accepted:
04
11
2022
entrez:
5
1
2023
pubmed:
6
1
2023
medline:
6
1
2023
Statut:
epublish
Résumé
Surrogate endpoints (SEs), such as progression-free survival (PFS) and objective response rate (ORR), are frequently used in clinical trials. The relationship between SEs and overall survival (OS) has not been well described in metastatic urothelial cancer (MUC). We evaluated trial-level data to assess the relationship between SEs and OS. We hypothesize a moderate surrogacy relationship between both PFS and ORR with OS. We systematically reviewed phase 2/3 trials in MUC with two or more treatment arms, and report PFS and/or ORR, and OS. Linear regression was performed, and the coefficient of determination (R Of 3791 search results, 59 trials and 62 comparisons met the inclusion criteria. Of the 53 trials that reported PFS, 31 (58%) reported proportional hazard regression for PFS and OS. Linear regression across trials demonstrated an R PFS provides only a moderate level of surrogacy for OS; An HR We examined the relationship between surrogate endpoints, common outcomes in clinical trials, with survival in urothelial cancer trials. Progression-free survival is moderately correlated, while objective response rate had a poor correlation with survival and should be de-emphasized as a primary endpoint.
Sections du résumé
Background
UNASSIGNED
Surrogate endpoints (SEs), such as progression-free survival (PFS) and objective response rate (ORR), are frequently used in clinical trials. The relationship between SEs and overall survival (OS) has not been well described in metastatic urothelial cancer (MUC).
Objective
UNASSIGNED
We evaluated trial-level data to assess the relationship between SEs and OS. We hypothesize a moderate surrogacy relationship between both PFS and ORR with OS.
Design setting and participants
UNASSIGNED
We systematically reviewed phase 2/3 trials in MUC with two or more treatment arms, and report PFS and/or ORR, and OS.
Outcome measurements and statistical analysis
UNASSIGNED
Linear regression was performed, and the coefficient of determination (R
Results and limitations
UNASSIGNED
Of 3791 search results, 59 trials and 62 comparisons met the inclusion criteria. Of the 53 trials that reported PFS, 31 (58%) reported proportional hazard regression for PFS and OS. Linear regression across trials demonstrated an R
Conclusions
UNASSIGNED
PFS provides only a moderate level of surrogacy for OS; An HR
Patient summary
UNASSIGNED
We examined the relationship between surrogate endpoints, common outcomes in clinical trials, with survival in urothelial cancer trials. Progression-free survival is moderately correlated, while objective response rate had a poor correlation with survival and should be de-emphasized as a primary endpoint.
Identifiants
pubmed: 36601043
doi: 10.1016/j.euros.2022.11.003
pii: S2666-1683(22)02684-2
pmc: PMC9806712
doi:
Types de publication
Journal Article
Langues
eng
Pagination
58-64Informations de copyright
© 2022 The Authors.
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