Safety and tolerability in patients over age 75 included in phase I: The Institut Gustave Roussy experience.

Abstract

9556 Background: Safety and tolerability of anti-cancer therapy in elderly people (>=75 years, EP) is of major interest since they represent 31% of US patients diagnosed with cancer. However proportion of EP recruited is only 9% in clinical trials and probably less in phase I trials, which aim to determine the recommended phase II dose. Our objective was to evaluate the safety of phase I trials in EP. Methods: Patients treated from 2007 to 2012 at Institut Gustave Roussy in phase I trials, in which patients aged over 75 years had been included. Population was divided into two groups: EP or patients aged < 75 years (YP). Time to occurrence of first high toxicity (any grade 3-4 adverse event (AE) or dose-limiting toxicity DLT) and overall survival were estimated using Kaplan-Meier method. Conditional Cox proportional hazards model was used to compare occurrence of AE in a sub population of patients aged >= 75 years matched with patients aged <75 years of same Royal Marsden Hospital (RMH) score (Albumin, LDH, Number of metastatic site) and protocol. Results: In the 33 EP and the 161 YP, 20(60%) and 100(62%) grade 3-4 AEs and 1(3%) and 18(11%) DLTs occurred. The median time to occurrence of high toxicity were 2 months (95%CI=1-4) and 2 months (95%CI=1-2). The median overall survival were 22 months (95%CI=11-non estimable) (EP) and 13 months (95%CI =10-16) (YP). Twenty-seven patients aged >=75 years could be matched: age over 75 years was not associated with higher risk of neither high toxicity (HR=0.85, 95%CI=[0.45 ; 1.61], p=.62) nor death (HR=1.03, 95%CI=[0.47;2.24], p=.94). Conclusions: No impact of age over 75 years on occurrence of neither high toxicity nor death was identified. Patients above 75 years are good candidates for phase I trials.