Are phase I trials safe for older patients?

Publication date: Available online 8 September 2017 Source:Journal of Geriatric Oncology Author(s): Capucine Baldini, Olivia Le Saux, Carole Helissey, Sandrine Aspeslagh, Eduardo Castanon, Andreea Varga, Anas Gazzah, Rastio Bahleda, Olivier Mir, Christophe Massard, Jean-Charles Soria, Antoine Hollebecque Phase I clinical trials in oncology primarily aim to assess the toxicity profile of new drugs and determine recommended phase II doses (RP2D). Since the cancer rate increases with age and our population is continually aging, RP2D must necessarily be assessed in older patients. Few clinical studies include older patients, however, and particularly few Phase I trials. We reviewed published data on the safety and efficacy of Phase I trials in older patients. The majority of studies included primarily young, fit patients, with age thresholds varying widely from 65 to 80years. However, age does not seem to be associated with more toxicity or less efficacy. While Phase I trials seem feasible in fit older patients, geriatric-medicine score systems should be included in the clinical trial design in order to better characterize this population.
Source: Journal of Geriatric Oncology - Category: Cancer & Oncology Source Type: research