Patients aged over 75 years enrolled in Phase I clinical trials: the Gustave Roussy experience

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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.

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Are cancer patients older than 75 unfairly excluded from clinical trials? Though a third of cancers are diagnosed in people over 75, most treatments are developed using data from younger patients. This study investigated whether phase I clinical trials pose a greater danger of toxicity in older patients. The authors examined data from studies that included patients younger and older than 75, and compared toxicity and efficacy results. They found no increase in the rate of toxic side effects in older patients, indicating that elderly patients could safely be included in more clinical trials.

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