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Patients aged over 75 years enrolled in Phase I clinical trials: the G ustave R oussy experience
Author(s) -
Helissey Carole,
Biondani Pamela,
Roquet Florian,
Lanoy Emilie,
Mir Olivier,
Varga Andrea,
Massard Christophe,
Gazzah Anas,
Ribrag Vincent,
Bahleda Ratislav,
PostelVinay Sophie,
Angevin Eric,
Deutsch Eric,
Soria JeanCharles,
Hollebecque Antoine
Publication year - 2015
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.29849
Subject(s) - medicine , toxicity , clinical trial , proportional hazards model , limiting , surgery , mechanical engineering , engineering
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.