Elderly patients with advanced NSCLC in phase III clinical trials: are the elderly excluded from practice-changing trials in advanced NSCLC?

Abstract

Introduction: Elderly patients constitute the majority of patients with advanced non-small-cell lung cancer (NSCLC). The median age of newly diagnosed patients with lung cancer in the United States is approximately 70 years. Despite this, the elderly are significantly underrepresented in clinical trials. This has led to increasing uncertainty as to their optimal treatment. Here, we seek to determine the proportion of elderly patients in key phase III clinical trials in advanced NSCLC.

Methods: A literature search for all phase III trials of systemic therapy for advanced NSCLC between 1980 and 2010 was performed using PubMed. The 100 most highly cited trials were then determined using the "Web of Science" application. The inclusion criteria and results of each of these studies were examined for the exclusion of elderly patients, median patient age, and age range.

Results: A total of 248 trials were reviewed. Among the 100 most cited trials, 33% specifically excluded elderly patients in their trial design (age exclusion ranged from >65 to >75 years of age). The average-reported patient median age in these trials was 60.9 years. The average age for trials that did not exclude elderly patients was not significantly different at 61.0 (p = 0.97). The average median age of patients was 61 years (95% confidence interval (CI): 60.4-61.6) in all trials.

Conclusion: Elderly patients are significantly underrepresented in these recent key practice-defining trials. Greater representation of elderly patients in phase III trials is required to better define evidence-based treatment paradigms in the increasingly elderly NSCLC population.