Optimising Clinical Trial Design in Older Cancer Patients

Cancer is predominantly a disease of older patients, with over half of those aged over 65 years of age being diagnosed with cancer at some stage. Despite comprising a significant proportion of the patients that we see in clinical practice, there is a lack of representation of older patients in cancer clinical trials. This is mainly due to restrictive trial inclusion criteria that prevent older patients from participating. Also, trial endpoints, such as overall survival, may not represent the most important and most meaningful endpoints for older patients. The latter may place more significance on quality of life and other outcomes such as functional independence. Baseline assessment using Comprehensive Geriatric Assessment, may provide a better framework for quantifying patient outcomes for varying degrees of fitness or frailty. This short communication makes the case for more age appropriate endpoints, such as quality of life, toxicity and functional independence, and that novel trial designs are necessary to inform evidence-based care of older cancer patients.