title: Patients aged over 75 years enrolled in Phase I clinical trials: the Gustave Roussy experience.
abstract: Although a third of all cancers are diagnosed after the age of 75, only 9% of elderly people are recruited in clinical trials, because of fear of the risk of toxicity. The aim of this study was to compare the tolerance and efficacy observed in Phase I trials among patients aged over 75 years with that observed in younger patients. Patients treated from 2007 to 2012 at Institut Gustave Roussy in Phase I trials were included. The conditional Cox proportional hazards model was used to compare the occurrence of AE and overall survival in a subpopulation of elderly people (EP, aged >75 years) matched with patients aged <75 years (YP) according to the same Phase I protocol and the same Royal Marsden Hospital (RMH) prognostic score. Among the 32 EP and the 158 YP, 63% and 61% experienced Grade 3-4 AEs and dose-limiting toxicities occurred in 6% and 11% in each group respectively. Age over 75 years was neither associated with a greater risk of high toxicity (HR=0.90 [CI95%, 0.47-1.70], p = 0.74) nor of death (HR=0.86; CI95%: 0.38-1.93; p = 0.71). Age over 75 years had no impact on the occurrence of either high toxicity or of death.
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Carole
authors.initials: C
authors.lastname: Helissey
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Pamela
authors.initials: P
authors.lastname: Biondani
authors.affiliation: Department of Biostatistics and Epidemiology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Florian
authors.initials: F
authors.lastname: Roquet
authors.affiliation: Department of Biostatistics and Epidemiology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Emilie
authors.initials: E
authors.lastname: Lanoy
authors.affiliation: Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Mir
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Andrea
authors.initials: A
authors.lastname: Varga
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Massard
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Anas
authors.initials: A
authors.lastname: Gazzah
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Ribrag
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Ratislav
authors.initials: R
authors.lastname: Bahleda
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Postel-Vinay
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Angevin
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Deutsch
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Soria
authors.affiliation: Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.|Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif Cedex, 94805, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Hollebecque
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D016016:Proportional Hazards Models; D035842:Research Subjects / Q000706:statistics & numerical data*
chemical_list: D000970:Antineoplastic Agents
keywords: Phase I trial; cancer; drug development; elderly patients; toxicity