Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study.

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License: CC BY 4.0
Serval ID
serval:BIB_A5AEE20D374F
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study.
Journal
European journal of cancer
Author(s)
Da Silva Lopes A.M., Colomer-Lahiguera S., Mederos Alfonso N., Aedo-Lopez V., Spurrier-Bernard G., Tolstrup L.K., Pappot H., Aspeslagh S., Rogiers A., Neyns B., Haanen J.B., Mitchell S.A., Addeo A., Michielin O., Eicher M.
ISSN
1879-0852 (Electronic)
ISSN-L
0959-8049
Publication state
Published
Issued date
11/2021
Peer-reviewed
Oui
Volume
157
Pages
225-237
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhibitors (ICIs) may not be fully covered by existing measures like the PRO-CTCAE™. Selecting PRO-CTCAE™ items for monitoring symptomatic adverse events is hindered by the heterogeneity and complexity of IrAEs, and no standardised selection process exists. We aimed to reach expert consensus on the PRO-CTCAE™ symptom terms relevant for cancer patients receiving ICIs and to gather preliminary expert opinions about additional symptom terms reflecting ICI symptomatic toxicities. Additionally, we gathered expert consensus about a core set of priority symptom terms for prospective surveillance and monitoring.
This Delphi study involved an international panel of experts (n = 6 physicians; n = 3 nurses, n = 1 psychiatrist and n = 1 patient advocates). Experts prioritised the relevance and importance of symptom terms to monitor in patients treated with ICIs.
Experts reached a consensus on the relevance of all (n = 80) PRO-CTCAE™ Symptom Terms. Consensus on the importance of these symptom terms for prospective monitoring in patients receiving ICIs was reached for 81% (n = 65) of these terms. Additional symptoms terms (n = 56) were identified, with a consensus that 84% (47/56) of these additional symptom terms should also be considered when monitoring symptomatic IrAEs.
This study identified a prioritised list of symptom terms for prospective surveillance for symptomatic IrAEs in patients receiving ICI treatment. Our results indicate the need to strengthen the validity of PRO measures used to monitor patients receiving ICIs. While these results provided some support for the content validity of the PRO CTCAE™ and resulted in a preliminary set of salient symptomatic adverse events related to the use of ICIs, broader international agreement and patient involvement are needed to further validate our initial findings.
Keywords
Consensus, Delphi Technique, Drug Monitoring/standards, Drug-Related Side Effects and Adverse Reactions/diagnosis, Drug-Related Side Effects and Adverse Reactions/immunology, Humans, Immune Checkpoint Inhibitors/adverse effects, Neoplasms/drug therapy, Neoplasms/immunology, Patient Reported Outcome Measures, Prospective Studies, Severity of Illness Index, Delphi consensus, Immune checkpoint inhibitors, PRO-CTCAE™, Patient-reported outcomes, Symptomatic immune-related adverse events
Pubmed
Web of science
Open Access
Yes
Create date
17/09/2021 9:06
Last modification date
13/01/2024 8:20
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