A phase I trial of adenoviral p53 gene therapy for non-small cell lung cancer

Lung cancer is one of the leading causes of cancer deaths worldwide. The high mortality rate for lung cancer results from the absence of standard therapeutic strategies, suggesting that lung cancer may be a suitable target disease for a novel gene-based therapy. Restoration of the function of a single pivotal gene product appears sufficient to mediate antitumor effects that are potentially clinically significant. Preclinical studies in animal models have demonstrated tumor regression following intratumoral administration of an adenovirus vector containing The wild-type tumor suppressor p53 gene. The efficacy and safety of the p53 gene therapy protocol for non-small cell lung cancer are now being evaluated in clinical trials. Although much research needs to be done following trials in the earliest stages, the treatment may offer a unique mechanism of action with a potentially high therapeutic index. This article reviews recent highlights in this rapidly evolving field.