Abstract 1702P
Background
The primary endpoint is the most important outcome, measuring patients’ benefits of therapy in clinical trials. There are well-established primary endpoints of confirmatory phase III trials, such as overall survival (OS), disease-free survival (DFS) and progression-free survival (PFS), but these outcomes may not represent the true benefits of older patients with cancer. Thus, we examined all phase III trials for older patients with or without cancer to identify appropriate primary endpoints of phase III trials specific to older patients with cancer.
Methods
We examined the United States National Institutes of Health Clinical Trial Registry on 30 September 2020 to identify studies that met the following criteria: interventional study, phase III trial and inclusion of older adults (>65 years of age). We extracted primary endpoints and other information of these trials from the registry’s website. Moreover, we analysed all primary endpoints of both geriatric oncology and geriatric non-oncology trials.
Results
A total of 31,073 trials were included in the analysis. As per our eligibility criteria, we identified 128 geriatric oncology trials and 236 geriatric non-oncology trials, respectively. In geriatric oncology trials, 115 (90%) trials used classic primary endpoints, such as OS, RFS, DFS, response rate, but the other trials used specific primary endpoints, such as quality of life (QOL) and activity of daily living (ADL). In geriatric non-oncology trials, the primary endpoints were heterogeneous, e.g. cognition, delirium, physical functioning, falls, depression, nutrition, insomnia, osteoporosis, hypertension and stroke. Only eight (3.2%) trials included survival, and they sometimes used composite endpoints, e.g. disability-free survival: the primary composite end point was derived from the first occurrences of the endpoint events of death, dementia and persistent physical disability.
Conclusions
Although survival is an important endpoint even in geriatric oncology trials, it may not be beneficial for older patients. Including geriatrics-specific domains would lead to more beneficial primary endpoints for older patients with cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
Health Labour Sciences Research Grant.
Disclosure
The author has declared no conflicts of interest.