p53 Gene therapy for lung cancer.

The gene transfer of the tumor suppressor p53 gene has been shown to induce tumor regression in preclinical models. Recent phase I and II studies have been completed in lung cancer with adenoviral-mediated transfer of wild-type p53 (Ad-p53) either alone or in combination with chemotherapy or radiotherapy. These studies have demonstrated acceptable toxicity and evidence of tumor regression with intratumoral delivery of Ad-p53. The predominant clinical effect appears to be locoregional in the area of intratumoral delivery. Further phase III studies are needed to determine if Ad-p53 will play a therapeutic role as a novel agent to treat non-small-cell lung cancer.