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 over recent years and is presently 70 years. Despite this, the elderly are significantly underrepresented in clinical trials.
A recent study investigated the degree to which exclusion or underrepresentation of elderly patients occurs in practice-changing clinical trials in advanced NSCLC. The researchers 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.
The research team did an extensive literature search, and included articles for review if they were phase III, involved systemic therapy alone, studied advanced NSCLC, and were conducted between 1980 and 2010. The authors identified 248 studies and reviewed their full texts.
Among the 100 most cited trials, 33% excluded elderly patients in their trial design. The age exclusions ranged from older than 65 years to older than 75 years. The average reported median patient age in those trials was 60.9 years. In trials that did not exclude elderly patients, the median age was similar, at 61.0 years. In all the trials, the average median age of patients was 61 years.
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. This study was published in the Journal of Thoracic Oncology (2013; doi:10.1097/JTO.0b013e31827e2145).