title: p53 gene therapy-based transarterial chemoembolization for unresectable hepatocellular carcinoma: A prospective cohort study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Hepatobiliary Surgery, Chongqing Cancer Institute, Chongqing, China.
authors.forename: Ai
authors.initials: A
authors.lastname: Shen
authors.affiliation: Department of Medical Oncology, Chongqing Cancer Institute, Chongqing, China.
authors.forename: Shihong
authors.initials: S
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, Chongqing Cancer Institute, Chongqing, China.
authors.forename: Weiqian
authors.initials: W
authors.lastname: Yu
authors.affiliation: Department of Hepatobiliary Surgery, Chongqing Cancer Institute, Chongqing, China.
authors.forename: Hejun
authors.initials: H
authors.lastname: Deng
authors.affiliation: Department of Hepatobiliary Surgery, Chongqing Cancer Institute, Chongqing, China.
authors.forename: Qingdong
authors.initials: Q
authors.lastname: Li
mesh_terms: D000256:Adenoviridae; D000328:Adult; D000368:Aged; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D015331:Cohort Studies; D003131:Combined Modality Therapy; D005260:Female; D018014:Gene Transfer Techniques; D015316:Genetic Therapy / Q000379:methods*; D005822:Genetic Vectors; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D015996:Survival Rate; D016159:Tumor Suppressor Protein p53 / Q000008:administration & dosage*
chemical_list: D011994:Recombinant Proteins; D016159:Tumor Suppressor Protein p53
keywords: hepatocellular carcinoma; recombinant adenovirus p53 injection; transarterial chemoembolization