Optimising Clinical Trial Design in Older Cancer Patients

Abstract

Abstract:Cancer is predominantly a disease of older patients, with over half of those aged over 65 years of age being diagnosed with cancer at some stage. Despite comprising a significant proportion of the patients that we see in clinical practice, there is a lack of representation of older patients in cancer clinical trials. This is mainly due to restrictive trial inclusion criteria that prevent older patients from participating. Also, trial endpoints, such as overall survival, may not represent the most important and most meaningful endpoints for older patients. The latter may place more significance on quality of life and other outcomes such as functional independence. Baseline assessment using Comprehensive Geriatric Assessment, may provide a better framework for quantifying patient outcomes for varying degrees of fitness or frailty. This short communication makes the case for more age appropriate endpoints, such as quality of life, toxicity and functional independence, and that novel trial designs are necessary to inform evidence-based care of older cancer patients.

Retrospective analysis of the effectiveness and tolerability of nab‐paclitaxel in Chinese elderly patients with advanced non‐small‐cell lung carcinoma

“…Elderly patients are often excluded from clinical trials because of their comorbidities and frailty, but they represent the majority of the patients with NSCLC . Indeed, the median age at NSCLC diagnosis was 70 years .…”

“…Older patients often present with poor performance status and/or comorbidities, and many receive only the best supportive care . Elderly patients are often underrepresented in clinical trials because of anticipated toxic effects, frailty, and comorbidities, and new therapeutic options are limited . The median age in large clinical trials is 60.9 years, whereas the median age for all patients diagnosed with NSCLC is 70 years .…”

Current Challenges Faced by Cancer Clinical Trials in Addressing the Problem of Under-Representation of Older Adults: A Narrative Review

“…For example, instead of overall survival or progression-free survival, investigators might consider quality of life, toxicity of treatment and maintaining functional independence as markers of treatment outcome in older adults. Measurement of disease-specific survival is useful as it indicates the number of patients who actually die as a result of cancer as opposed to other chronic conditions [ 44 ].…”

Real‑world challenge for clinicians treating advanced gastroesophageal adenocarcinoma (Review)

“…To address this issue, the inclusion of frailer patients in clinical trials, who more resemble those encountered in practice, as well as the incorporation of appropriate endpoints has been highlighted as a priority for the American Society of Clinical Oncology (ASCO), the International Society of Geriatric Oncology (SIOG) and the European Organization for Research and Treatment of Cancer (EORTC). They have produced reports on the topic (73,(98)(99)(100) and have suggested removing the upper age limit of trials and the design of specific trials for older patients where standard therapy is not feasible with integrated appropriate measures of outcome.…”