Analysis of lung cancer patients enrolled in CTEP (cancer therapy evaluation program)-sponsored phase I trials.

Introduction: A recent review of phase I trials suggests that participation in these trials can be associated with clinical benefit and the rate of drug-related deaths is low. We conducted an analysis of the Cancer Therapy Evaluation Program (CTEP)-sponsored phase I trials to assess the outcomes of lung cancer patients enrolled in phase I trials.

Materials And Methods: Data from all CTEP-sponsored adult phase I trials conducted between 1997 and 2008 were analyzed. An analysis of demographics, rates of toxicities, and clinical benefit rate among patients with non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), and other cancers was conducted.

Results: Of the 3560 patients enrolled in 136 phase I trials, 301 (8.5%) had NSCLC and 40 (1.1%) had SCLC. The median age of lung cancer patients, at 60 years, was significantly higher than patients with other cancers. The rest of the demographics were similar among the groups. The rate of Grade 3-5 toxicities was higher among NSCLC patients (54% versus 46%). The toxicity-related death rate was ≤ 1% among all groups. The clinical benefit rate and median duration in study of approximately 2 months were similar among all groups of patients.

Conclusion: An analysis of the CTEP-sponsored phase I trials shows that lung cancer patients enrolled in these trials have a similar incidence of toxicity-related deaths and a similar probability of clinical benefit as patients with other cancers. These data suggest that patients with progressive lung cancer following approved therapies should be considered for phase I trials.