Do Symptoms Matter When Considering Patients for Phase I Clinical Trials? A Pilot Study of Older Adults With Advanced Cancer

Older adults (OA) with advanced cancer (AC) undergoing phase 1 clinical trials (PICT) have poor prognosis. There are no studies which describe symptoms experienced by OA. Methods: Retrospective chart review of PICT participants > 60 years. OA were compared by age (> 65 vs 60-65) and by number of symptoms (> 3 vs <= 3). Results: N = 56. Mean age = 67.09; 48.21% female. Median life-expectancy = 5 months (interquartile range = 2-9 months); 80.36% had pain; of those 64% without pain scale. Most did not have interdisciplinary professionals or hospice referrals. Older adults with > 3 symptoms had more admissions (37.5% vs 14.29%; P = .0335), complications (46.43% vs 16.07%; P = .0026), and greater decline in functional status (24 participants > 3 symptoms vs 8; P = .0173). There were no significant differences comparing OA by age. Conclusions: Older adults enrolled in PICT with more symptoms may sacrifice QOL for experimental treatment.