Patients aged over 75 years enrolled in Phase I clinical trials: the Gustave Roussy experience.
Int J Cancer
; 138(4): 875-80, 2016 Feb 15.
Article
em En
| MEDLINE
| ID: mdl-26370299
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Fase I como Assunto
/
Sujeitos da Pesquisa
/
Neoplasias
/
Antineoplásicos
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Int J Cancer
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
França