Purpose: The aim of the present study was to identify elderly-specific clinical trials for advanced non-small cell lung cancer (NSCLC) and to clarify the study design and patient characteristics entered of each of these trials.
Methods: We used the MEDLINE database to select prospective clinical trials evaluating the efficacy of chemotherapy in elderly patients with advanced NSCLC.
Results: Our literature search yielded 48 prospective clinical trials between 1990 and 2003, involving a total of 2648 elderly patients with advanced NSCLC. The median number of patients treated per trial was 36. In 23 (48%) of the 48 trials, only the abstract was available. In 44 trials (92%), elderly patients were defined using their calendar age, and the age of 70 years was the most frequently used lower limit for inclusion. Vinorelbine was the most widely studied chemotherapy agent in elderly patients.
Conclusions: Our review revealed that (i) the definition of "elderly" varied from trial to trial, and elderly patients were simply defined using calendar age in the clinical trials; (ii) the quality of elderly-specific trials were generally poor, mainly because of their small sample size.