Are phase I trials safe for older patients?

Capucine Baldini, Olivia Le Saux, Carole Helissey, Sandrine Aspeslagh, Eduardo Castanon, Andrea Varga, Anas Gazzah, Rastilav Bahleda, Olivier Mir, Christophe Massard, Jean-Charles Soria, Antoine Hollebecque

Research output: Contribution to journalScientific review

1 Citation (Scopus)


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.

Original languageEnglish
Pages (from-to)87-92
Number of pages6
JournalJournal of Geriatric Oncology
Issue number2
Publication statusPublished - Mar 2018

Bibliographical note

Copyright © 2017 Elsevier Inc. All rights reserved.


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

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