Brief Article
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World J Gastroenterol. Apr 28, 2011; 17(16): 2143-2149
Published online Apr 28, 2011. doi: 10.3748/wjg.v17.i16.2143
p53 gene therapy in combination with transcatheter arterial chemoembolization for HCC: One-year follow-up
Yong-Song Guan, Yuan Liu, Qing He, Xiao Li, Lin Yang, Ying Hu, Zi La
Yong-Song Guan, Yuan Liu, Qing He, Xiao Li, Lin Yang, Ying Hu, Zi La, Department of Oncology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Author contributions: Guan YS supervised the entire process of design and execution of the study and writing of the manuscript, and corrected the paper; Liu Y drafted the paper and organized the figures and patient data; He Q, Li X, Yang L, Hu Y and La Z completed the follow-up of patients and data collection.
Correspondence to: Yong-Song Guan, Professor, Department of Oncology West China Hospital, Sichuan University, 37 Guoxuexiang, Chengdu 610041, Sichuan Province, China.
Telephone: +86-28-85421008 Fax: +86-28-85538359
Received: August 15, 2010
Revised: November 13, 2010
Accepted: November 20, 2010
Published online: April 28, 2011

AIM: To evaluate the efficacy and safety of combination therapy with recombinant adenovirus p53 injection (rAdp53) and transcatheter hepatic arterial chemoembolization (TACE) for advanced hepatocellular carcinoma (HCC).

METHODS: A total of 82 patients with advanced HCC treated only with TACE served as control group. Another 68 patients with HCC treated with TACE in combination with recombinant adenovirus-p53 injection served as p53 treatment group. Patients were followed up for 12 mo. Safety and therapeutic effects were evaluated according to the improvement in clinical symptoms, leukocyte count, Karnofsky and RECIST criteria. Survival rate was calculated with Kaplan-Meier method.

RESULTS: The total effective rate was 58.3% for p53 treatment group, and 26.5% for control group (P < 0.05). The incidence of gastrointestinal symptoms was lower in p53 treatment group than in control group (P < 0.05). The 3-, 6- and 12-mo survival rates were significantly higher for p53 treatment group than for control group (P < 0.01). The combination treatment was well tolerated with such adverse events as fever (51.5%, P = 0.006) and pain of muscles and joints (13.2%, P = 0.003), which were significantly higher than the chemotherapy. Except for these minor adverse effects, no severe vector-related complications were identified. With respect to the efficacy, patients in p53 treatment group had less gastrointerestinal symptoms (P = 0.062), better improvement in tumor-related pain (P = 0.003), less downgrade of leukocyte counts (P = 0.003) and more upgrade of Karnofsky performance score (P = 0.029) than those in control group. The total effective rate (CR + PR) for p53 treatment group and control group was 58.3% and 26.5%, respectively, with distributions of different effect in two groups (P = 0.042). The survival rates were 89.71%, 76.13%, and 43.30% for p53 treatment group, and 68.15%, 36.98%, and 24.02% for control group, respectively, 3, 6 and 12 mo after treatment, suggesting that the survival rates are significantly higher for p53 treatment group than for control group (P = 0.0002).

CONCLUSION: The rAd-p53 gene therapy in combination with TACE is a safe and effective treatment modality for advanced HCC.

Keywords: Adenovirus p53, Clinical trial, Hepatocellular carcinoma, Transcatheter hepatic arterial chemoembolization, p53 gene therapy