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J Geriatr Oncol. 2018 Mar;9(2):87-92. doi: 10.1016/j.jgo.2017.08.012. Epub 2017 Sep 8.

Are phase I trials safe for older patients?

Author information

1
Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex F-94805, France. Electronic address: capucine.baldini@gustaveroussy.fr.
2
Unité d'Oncogériatrie, Service de Gériatrie, Centre Hospitalier Lyon Sud, F-69310 Pierre-Bénite, France.
3
Service Oncologie Médicale HIA Bégin, F-94160 Saint-Mandé, France.
4
Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif Cedex F-94805, France.

Abstract

Phase I clinical trials in oncology primarily aim to assess the toxicity profile of new drugs and determine recommended phase II doses (RP2D). Since the cancer rate increases with age and our population is continually aging, RP2D must necessarily be assessed in older patients. Few clinical studies include older patients, however, and particularly few Phase I trials. We reviewed published data on the safety and efficacy of Phase I trials in older patients. The majority of studies included primarily young, fit patients, with age thresholds varying widely from 65 to 80years. However, age does not seem to be associated with more toxicity or less efficacy. While Phase I trials seem feasible in fit older patients, geriatric-medicine score systems should be included in the clinical trial design in order to better characterize this population.

KEYWORDS:

Cancer; Drug development; Older patients; Phase I trial; Toxicity

PMID:
28890328
DOI:
10.1016/j.jgo.2017.08.012
[Indexed for MEDLINE]

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