Are the elderly excluded from practice-changing trials in advanced NSCLC?

Greater representation of elderly patients in phase III trials is needed

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 study published in the March 2013 issue of the International Association for the Study of Lung Cancer's Journal of Thoracic Oncology investigated the degree to which exclusion or underrepresentation of the elderly occurs in practice-changing clinical trials in advanced NSCLC. Researchers conclude that greater representation of elderly patients in phase III trials is required to better define evidence-based paradigms in the increasingly elderly NSCLC population.

Better representation can improve evidence-based treatment

The researchers from Princess Margaret Hospital & University Health Network, University of Toronto, Toronto, Canada performed an extensive literature search and targeted articles for review if the studies described 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 (age exclusion ranged from >65 to >75 years of age). The average reported median patient age in those trials was 60.9 years. The average age for trials that did not exclude elderly patients was not significantly different at 61.0. The average median age of patients was 61 years in all trials.

The authors "have 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.

The lead author of this paper is Dr Adrian Sacher.