Trans-arterial p53-gene-embolization with gelatin sponge microparticles for hepatocellular carcinoma with BCLC stage B: single-center experience.

Trans-arterial chemoembolization for hepatic cellular carcinoma (HCC) is a recommended treatment schedule for stage B patients under the Barcelona-Clinic Liver Cancer (BCLC) diagnostic and treatment strategy system. Data from treatments with embolization performed with different embolizing microparticle reagents either alone or in combination with different chemotherapeutic agents showed favorable safety profile and significant efficacy in tumor control. In addition, recombinant adenoviral human p53 gene (rAd-p53) therapy has been shown effective in the treatment of many solid tumors and some pre-cancerous lesions such as oral leukoplakia, while also presenting a favorable safety profile. To date, no data are available regarding the safety and efficacy of trans-catheter treatment of HCC with embolizing microparticles combined with rAd-p53 in the world. In this study, we demonstrated the safety and efficacy of trans-arterial embolization combined with rAd-p53 gene therapy (TAGE) in the treatment of patients with BCLC stage B HCC. In this retrospective study, 15 HCC patients with BCLC stage B were received TAGE. Fifteen males were included with an average age of 65 (53-89) years and with Child-Pugh score A or B (12 or 3, respectively). The embolic agent used in TAE was gelatin sponge microparticles of diameter 350-560 µm, and 3-5 × 10(12) viral of rAd-p53 was diluted with physiological saline into 15 ml suspension. The study endpoints included response rate, 1 year survival, liver function, and adverse effects. With a median follow-up time of 15.5 months, 15 HCC patients received a total number of 64 TAGE treatments without any significant complication. Based on the modified response evaluation criteria in solid tumors, complete response (CR) was observed in four, six, and six patients at 1, 3, and 6 months after the first treatment, respectively. The objective tumor response (CR + PR) rates at 1, 3, and 6 months were 100.0, 93.3, and 80.0%. The total survival rates of 6 and 12 months in 15 patients were 100%, 100% respectively. The median survival time was 32 months in all. Mild or median fever was observed in all 15 patients, which occurred 4-12 h after treatment and lasted for 12-24 h. Transient abdominal pain, nausea, and cholecystitis were the common side effects with a frequency of 46.7, 33.3, and 26.7%, respectively, and three cases (20%) showed decrease in platelet count. However, other severe (grade 3 or 4) adverse events associated with TAGE were not observed. TAGE is a safe and effective treatments for HCC with BCLC stage B HCC patients.