Assessment of endpoint definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: Head and Neck Cancer International Group consensus recommendations
- Author(s)
- Lim, AM; McDowell, L; Hurt, C; Le Tourneau, C; Homma, A; Shenouda, G; Thomson, DJ; Moya-Plana, A; Henson, C; Szturz, P; Day, AT; Bates, JE; Lazarakis, S; Thariat, J; Psyrri, A; Mehanna, H; Yom, SS; HNCIG;
- Details
- Publication Year 2024-07,Volume 25,Issue #7,Page e318-e330
- Journal Title
- Lancet Oncology
- Publication Type
- Review
- Abstract
- Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.
- Publisher
- Elsevier
- Keywords
- Humans; *Squamous Cell Carcinoma of Head and Neck/pathology/therapy/mortality; *Consensus; *Head and Neck Neoplasms/therapy/pathology/mortality; *Endpoint Determination/standards; Clinical Trials, Phase III as Topic; Progression-Free Survival
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1016/s1470-2045(24)00067-6
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-08-06 05:29:24
Last Modified: 2024-08-06 05:31:19