Trials for older cancer patients

The study aimed to evaluate clinical trials focusing on older cancer patients, recognising their underrepresentation despite accounting for 40% of the cancer population. A systematic review was conducted, analysing data from Embase and PubMed from inception to March 2023, focusing on phase I, II, and III trials involving patients aged 70 and older with solid tumours.

Of the 313 studies included, most were phase II trials, with lung and colorectal cancers being the most common. Chemotherapy and targeted therapies were the primary treatments tested, with only one immunotherapy study. Geriatric assessments and quality of life analyses were included in 28% and 23% of studies, respectively, primarily in the palliative setting.

Results showed that 77.8% of the studies met at least 90% of the planned patient enrollment, with phase II trials being more successful than phase III trials, which often faced slow accrual and discontinuation. Additionally, 60% of the studies met their primary endpoints, predominantly in phase II trials, compared to 35% in phase III. A comparative analysis of age-selected versus age-unselected trials revealed that age-selected trials had higher enrollment success and met primary endpoints more frequently.

The findings suggest that while phase I and II trials are feasible for older patients, phase III trials encounter significant recruitment challenges. Future efforts should focus on overcoming these barriers and incorporating geriatric assessments and quality-of-life analyses. The study also aims to further explore safety outcomes, treatment schedules, and additional characteristics of trials for older cancer patients.