726. Clinical Trial of Recombinant Adenovirus-p53 (Gendicine) Combined with Radiotherapy in Nasopharyngeal Carcinoma Patients

Abstract

The study was to evaluate the safety and the efficacy of recombinant adenovirus-p53 (Adp53, trademarked as Gendicine) combined with radiotherapy in nasopharyngeal carcinoma (NPC) patients. A controlled clinical trial on Gendicine combined with radiotherapy, that is, gene therapy + radiotherapy (GTRT), was conducted in 24 patients, and 25 patients treated with radiotherapy alone (RT) formed the control group. In the GTRT group, Gendicine 1|[times]|1012 virus particle (vp) was intratumorally injected once a week over to eight weeks, and concurrent irradiation was given. For both groups, the conventional fractionation 2Gy/day, five fractions a week, with a total dose of 70Gy in 35 fractions were given to either primary tumor or neck lymph node. Patients were monitored for adverse event and serum anti-adenoviral antibody, and tumors were monitored for response. A comparative study was performed between both groups on the immediate response rate by CT at the end of 4th week, 7th week and 2 months after the treatment. The median follow-up interval of surviving patients was 34.5 months (24|[sim]|45 months). Wild-type p53 gene therapy enhanced significantly radiotherapy efficacy by 1.59 times in patients with NPC at 4- week time point. Two months after the treatment complete response rate of GTRT group was 2.1 times that of RT group (62.5% v.s. 29.6%). The 3-year overall survival rate of GTRT group was 14.4% higher than that of GT group. No dose-limiting toxicity and adverse events were noted, except for transient fever after Gendicine administration. Intratumoral injection with Gendicine was safe and effective for patients with NPC.