Adenovirus-mediated wild-type p53 gene transfer as a surgical adjuvant in advanced head and neck cancers

A high incidence of locoregional failure contributes to the poor overall su rvival rate of around 50% for patients with squamous cell carcinoma of the head and neck (SCCHN). III vitro and in vivo preclinical work with adenovir us-mediated wild-type p53 gene transfer using the recombinant p53 adenoviru s (Ad-p53) has shown its promise as a novel intervention strategy for SCCHN . These data have translated into Phase I and Phase II studies of Ad-p53 ge ne transfer in patients with advanced, locoregionally recurrent SCCHN, The safety and overall patient tolerance of Ad-p53 has been demonstrated. Of 15 resectable but historically noncurable patients in the surgical arm of a P hase I study, 4 patients (27%) remain free of disease, with a median follow -up time of 18.25 months. Surgical and gene transfer-related morbidities we re minimal. These results provide preliminary support for the use of Ad-p53 gene transfer as a surgical adjuvant in patients with advanced SCCHN. The implications of our findings for the management of SCCHN in general are dis cussed.