Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations.
Details
Serval ID
serval:BIB_AF66A4CF28EE
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations.
Journal
The Lancet. Oncology
Working group(s)
HNCIG
ISSN
1474-5488 (Electronic)
ISSN-L
1470-2045
Publication state
Published
Issued date
07/2024
Peer-reviewed
Oui
Volume
25
Number
7
Pages
e308-e317
Language
english
Notes
Publication types: Journal Article ; Review
Publication Status: ppublish
Publication Status: ppublish
Abstract
Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.
Keywords
Humans, Squamous Cell Carcinoma of Head and Neck/pathology, Squamous Cell Carcinoma of Head and Neck/mortality, Squamous Cell Carcinoma of Head and Neck/secondary, Squamous Cell Carcinoma of Head and Neck/therapy, Neoplasm Recurrence, Local/pathology, Consensus, Head and Neck Neoplasms/pathology, Head and Neck Neoplasms/mortality, Head and Neck Neoplasms/therapy, Endpoint Determination/standards, Clinical Trials, Phase III as Topic, Neoplasm Metastasis
Pubmed
Web of science
Create date
05/07/2024 10:01
Last modification date
13/07/2024 6:09