Why and how moving forward in clinical research for the older cancer patients?

Abstract

More than 60% of cancers will be soon diagnosed after 70 years, sparing no country. Clinical trials devoted to the older cancer patients ironically remain very few, hardly reaching 5% of those registered on ClinicalTrials.gov. Although innovative oncology is based on precision and personalized strategies, with an expected improved risk/benefit balance, and thus would fit very well the elderly population which has a higher risk of developing side effects, these numbers have changed little over the past decade. The main challenge remains promoting tailored designs and methodology that take into account specific older patients' expectations and unmet medical needs, which cannot be adequately addressed by the usual research conducted in the adult population. This means profound reforms to set oneself apart from these cancer clinical trials run in standard adult patients. Research priorities include: demonstrate the impact of geriatric case management to improve cancer prognosis; develop programs for groups of older patients stratified on frailty level, focusing on the most representative ones; address questions in the older elderly patients (>80); develop specific primary endpoints weighing quality of life or functionality with cancer-related targets in co-primary or composite endpoints; create a shift for organized de-escalation strategies, taking maximum advantage of targeted therapies versus conventional treatment in order to limit side effects; develop dose-escalation strategies (from doses lower than those approved in younger and fit adults) based on pharmacokinetics and assessment of functional reserves; improve the definition of a consensual minimal set of geriatric data to homogenize reports across groups and countries. As will be shown, all these goals rely on the development of a strong collaboration across borders and culture, as advocated by the International Society of Geriatric Oncology (SIOG) and collaborative groups as EORTC and DIALOG (GERICO/UCOG).