p53 gene therapy-based transarterial chemoembolization for unresectable hepatocellular carcinoma: A prospective cohort study.

ABSTRACT

BACKGROUND AND AIM: Transarterial chemoembolization (TACE) is used for treating unresectable hepatocellular carcinoma (HCC), but its efficacy still needs to be improved. Recombinant adenovirus p53 (rAd-p53) injection is a gene therapeutic agent that could improve the prognosis of HCC patients. This study aimed to evaluate the efficacy and safety of rAd-p53-based TACE for treating unresectable HCC. METHODS: Prospective analysis of patients who received rAd-p53-based TACE or TACE alone in Chongqing Cancer Institute from January 1, 2011 to December 31, 2012. The primary endpoint is overall survival. The secondary endpoints were progression-free survival, response rate, and safety. RESULTS: One hundred two patients were enrolled in this study. Forty-nine patients received the rAd-p53-based TACE, and 53 patients received TACE alone. The rAd-p53-based TACE treatment strategy improved the overall survival (hazard ratio 0.58, 95% confidence interval 0.35-0.96, P = 0.035), progression-free survival (hazard ratio 0.60, 95% confidence interval 0.37-0.97, P = 0.037), response rate (P = 0.047) compared with TACE monotherapy. The rAd-p53-based TACE treatment group caused more occurrences of fever than with TACE alone (P = 0.01). However, symptomatic treatment may solve this problem. CONCLUSIONS: rAd-p53-based TACE treatment strategy is effective and safe for treating unresectable HCC. Large-scale randomized clinical trials are needed to verify these results.