Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review.
Antineoplastic Agents, Immunological
/ administration & dosage
B7-H1 Antigen
/ antagonists & inhibitors
Biomarkers
CTLA-4 Antigen
/ antagonists & inhibitors
Disease-Free Survival
Humans
Neoplasms
/ drug therapy
Programmed Cell Death 1 Receptor
/ antagonists & inhibitors
Randomized Controlled Trials as Topic
Immune-checkpoint inhibitors
Literature review
Overall survival
Surrogate endpoints
Journal
Critical reviews in oncology/hematology
ISSN: 1879-0461
Titre abrégé: Crit Rev Oncol Hematol
Pays: Netherlands
ID NLM: 8916049
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
received:
04
12
2018
revised:
26
02
2019
accepted:
27
02
2019
entrez:
25
4
2019
pubmed:
25
4
2019
medline:
22
5
2019
Statut:
ppublish
Résumé
Surrogate endpoints (SEs) for overall survival (OS) are specific to therapeutic class. The objective of this review was to document all alternative endpoints studied for their association with OS in Immune-Checkpoint Inhibitors (ICI)-treated patients. We searched PubMed and Embase for publications reporting the association between a clinical endpoint and OS in ICI-treated populations from 01/01/2003 to 03/31/2018. Out of 6,335 references identified, 24 were selected. Only 3 studies assessed surrogacy at both the patient and trial levels. The main traditional alternative endpoints included progression-free survival (N = 10) and objective response rate (N = 8). New alternative endpoints, such as durable response rate (N = 1) and intermediate response endpoint (N = 1) statistically better correlate with OS in the cancer types analysed. Based on the published evidence, there is insufficient data to support validated SE for OS. Adequate surrogacy assessment of promising composite endpoints which consider a duration component is encouraged.
Sections du résumé
BACKGROUND
BACKGROUND
Surrogate endpoints (SEs) for overall survival (OS) are specific to therapeutic class. The objective of this review was to document all alternative endpoints studied for their association with OS in Immune-Checkpoint Inhibitors (ICI)-treated patients.
METHODS
METHODS
We searched PubMed and Embase for publications reporting the association between a clinical endpoint and OS in ICI-treated populations from 01/01/2003 to 03/31/2018.
RESULTS
RESULTS
Out of 6,335 references identified, 24 were selected. Only 3 studies assessed surrogacy at both the patient and trial levels. The main traditional alternative endpoints included progression-free survival (N = 10) and objective response rate (N = 8). New alternative endpoints, such as durable response rate (N = 1) and intermediate response endpoint (N = 1) statistically better correlate with OS in the cancer types analysed.
CONCLUSION
CONCLUSIONS
Based on the published evidence, there is insufficient data to support validated SE for OS. Adequate surrogacy assessment of promising composite endpoints which consider a duration component is encouraged.
Identifiants
pubmed: 31014514
pii: S1040-8428(19)30044-7
doi: 10.1016/j.critrevonc.2019.02.013
pii:
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
B7-H1 Antigen
0
Biomarkers
0
CD274 protein, human
0
CTLA-4 Antigen
0
CTLA4 protein, human
0
PDCD1 protein, human
0
Programmed Cell Death 1 Receptor
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
35-42Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.