Quality of life assessment and reporting in colorectal cancer: A systematic review of phase III trials published between 2012 and 2018.
Colorectal cancer
Endpoints
Health-related quality of life
Patient-reported outcomes
Randomized controlled trials
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:
Feb 2020
Feb 2020
Historique:
received:
21
07
2019
revised:
09
12
2019
accepted:
17
01
2020
pubmed:
26
1
2020
medline:
18
3
2020
entrez:
26
1
2020
Statut:
ppublish
Résumé
In this study, our aim was to describe quality of life (QoL) prevalence and heterogeneity in QoL reporting in colorectal cancer phase III trials. We included all phase III trials evaluating anticancer drugs in colorectal cancer patients published between 2012 and 2018 by 11 major journals. Out of the 67 publications identified, in 41 (61.2 %) QoL was not listed among endpoints. Out of 26 primary publications of trials including QoL among endpoints, QoL results were not reported in 10 (38.5 %). Overall, no QoL data were available in 51/67 (76.1 %) primary publications. In particular, in the metastatic setting, QoL data were not available in 12/18 (66.7 %) trials with primary endpoint overall survival, and in 20/29 (69.0 %) trials with other primary endpoints. QoL was absent in a high proportion of recently published phase III trials in colorectal cancer, even in trials of second or further lines, where attention to QoL should be particularly high.
Sections du résumé
BACKGROUND
BACKGROUND
In this study, our aim was to describe quality of life (QoL) prevalence and heterogeneity in QoL reporting in colorectal cancer phase III trials.
METHODS
METHODS
We included all phase III trials evaluating anticancer drugs in colorectal cancer patients published between 2012 and 2018 by 11 major journals.
RESULTS
RESULTS
Out of the 67 publications identified, in 41 (61.2 %) QoL was not listed among endpoints. Out of 26 primary publications of trials including QoL among endpoints, QoL results were not reported in 10 (38.5 %). Overall, no QoL data were available in 51/67 (76.1 %) primary publications. In particular, in the metastatic setting, QoL data were not available in 12/18 (66.7 %) trials with primary endpoint overall survival, and in 20/29 (69.0 %) trials with other primary endpoints.
CONCLUSIONS
CONCLUSIONS
QoL was absent in a high proportion of recently published phase III trials in colorectal cancer, even in trials of second or further lines, where attention to QoL should be particularly high.
Identifiants
pubmed: 31981880
pii: S1040-8428(20)30015-9
doi: 10.1016/j.critrevonc.2020.102877
pii:
doi:
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
102877Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Massimo Aglietta had roles as consultant or advisor for Roche, Bristol Myers Squibb, Merck and Co.; Giorgio Vittorio Scagliotti received honoraria, research funding and had roles as consultant or advisor for Roche, Pfizer, AstraZeneca, Lilly Pharma and MSD; Francesco Perrone received honoraria for regulatory or educational advisory board from AstraZeneca, Bayer, Celgene, Incyte, Janssen-Cilag, Pierre Fabre, Sandoz and received research funding from AstraZeneca, Baxter, Bayer, Incyte, Merck, Pfizer, Roche and Tesaro; Massimo Di Maio received honoraria and had roles as consultant or advisor for AstraZeneca, Lilly Pharma, Bristol Myers Squibb, MSD and Janssen. All remaining authors declared no conflicts of interest.