The study clearly demonstrated that a significant proportion of highly cited phase III clinical trials in advanced NSCLC overtly exclude elderly patients.
—Adrian G. Sacher, MD
The median age of patients diagnosed with advanced non–small cell lung cancer (NSCLC) has steadily increased in recent years and is presently 70 years. Despite this, the elderly are significantly underrepresented in clinical trials. A recent study published in the March 2013 issue of the International Association for the Study of Lung Cancer’s (IASLC) Journal of Thoracic Oncology,1 investigated the degree to which exclusion or underrepresentation of elderly occurs in practice-changing clinical trials in advanced NSCLC. Lead author Adrian G. Sacher, MD, of Princess Margaret Hospital & University Health Network, University of Toronto, Canada, and colleagues concluded that greater representation of elderly patients in phase III trials is required to better define evidence-based paradigms in the increasingly elderly NSCLC population.
Researchers did an extensive literature search, included articles for review if they were phase III, involved systemic therapy alone, studied advanced NSCLC, and were conducted between 1980 and 2010. A total of 248 studies were identified and their full text reviewed by the authors.
Among the 100 most cited trials, 33% excluded elderly patients in their trial design. The average reported median patient age in those trials was 60.9 years.
The authors noted that their investigation “clearly demonstrated that a significant proportion of highly cited phase III clinical trials in advanced NSCLC overtly exclude elderly patients.” They recommend that a greater emphasis be placed on recruiting clinical trial patients with age demographics that better represent the median age of the advanced NSCLC population. ■
1. Sacher AG, Le LW, Leighl NB, et al: Elderly patients with advanced NSCLC in phase III clinical trials. J Thorac Oncol 8:366-368, 2013.