Analysis of proportion of geriatric patients in phase III cancer clinical trials.

Abstract

e23032 Background: Geriatric patients are often under-represented in cancer clinical trials. The presence of multiple comorbidities makes geriatric patients ineligible for most clinical trials. However, the increase in cancer incidence in geriatric patients raises the question of applicability of the results is such clinical trials. Methods: Data about Phase 3 trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The time period studied was for the past 10 years and included only adult patients (≥ 18 years). The age distribution of the patient population in these trials were extracted and analyzed. Results: Geriatric patients are heavily under-represented in all phase 3 cancer clinical trials. Table shows the proportion of patients below 65 years, above 65 years and older in clinical trials for each organ specific malignancy. The range of the proportion of geriatric patients varied from 10% to 40%. Conclusions: The results of phase 3 clinical trials that are currently conducted on non-geriatric patient population may not meaningfully be applicable to geriatric patients. This study highlights the disparity of age for patients enrolled in clinical trials as against the patients seen in the real world.[Table: see text]