| Part 1:Animal ExperimentAim:To evaluate doxorubincine intra-tissue distribution using drug-eluting beads or lipiodol.Materials and Methods:Four New Zealand rabbits were allocated to two groups:3 for bead group(Group A) and 1 for lipiodol group (Group B). TACE were performed for both groups under general anesthesia, with 0.3ml drug-eluting beads containing HepaSphere 0.375mg and 0.75mg doxorubicin for Group A, and 0.3ml lipiodol emulsion consist of 0.75mg doxorubicin for Group B. The rabbits in group A were sacrificed 1h,3rd day and 7th day post-procedure, and 1h for group B. Frozen-section of the target live tissue was performed and drug auto-fluorescence analyzed.Result:Drug-eluting beads with doxorubicin auto-fluorescence were witnessed within and conformed to the artery. Lipiodol with doxorubicin auto-fluorescence was distributed mainly in the portal area.Conclusion:Drug-eluting beads may effectively load with doxorubicin; HepaSphere is conformable to the hepatic artery; Lipidol-doxorubicin mixture mainly distribute in the portal area.Part 2:Clinical InvestigationOne:Transarterial chemoembolization (TACE) with EmboSphere for unresectable hepatocellular carcinoma (HCC)Purpse:To investigate the feasibility, safety and effectiveness of transarterial chemoembolization (TACE) with EmboSphere for the treatment of unresectable hepatocellular carcinoma (HCC).Materials and Methods:From 2010 to February 2013, a total number of 179 patients who were diagnosed of hepatocellular carcinoma were randomized assigned to receive TACE with EmboSphere group (group A, N= 91) or conventional TACE group (group B, N= 88). The study protocol was approved by the institutional ethics committee, and informed consent was obtained from each patient. Tumor response was evaluated according to the mRECIST criteria. The primary end point were survival rate and time to progress, other end point including side effects and tumor response. Statistical analysis was performed using Kaplan-Meier estimator with log-rank testing, chi-squared, and independent t-tests.Results:179 patients were enrolled in this prospective study. Technique success rate was 100%. During the follow up time technique related side effect of CTCAE grade 3/4 occurred with 7 cases:6 cases with hepatic abscess (4 in group A and 2 in group B),1 with hepatic encephalopathy. The object response rate was 42.9% in group A and 31.9% in group B (P= 0.127). The mean TACE procedures per patient performed was significantly less in group A. The 1 year and 2 year survival rates were 63.9%and 50.5% in group A and 43.3% and 33.7 in group B (F=0.018), respectively. The 450 days disease progress free rate was significantly higher in group A (51.4% vs.31.7% P= 0.001). Patients with multifocal tumor type, objective response and EmboSphere had a better outcome.Conclusion:TACE with EmboSphere is feasible, safe and effective in the treatment of HCCTwo:transarterial chemoembolization (TACE) combined with endovascular implantation of iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumor thrombosis (PVTT)Purpose:To investigate the feasibility, safety and effectiveness of transarterial chemoembolization (TACE) combined with endovascular implantation of iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumor thrombosis (PVTT).Materials and Methods:From February 2011 to February 2013, a total number of 85 patients who were diagnosed of hepatocellular carcinoma with portal vein tumor thrombosis were randomized assigned to receive TACE combined endovascular implantation of iodine-125 seed strand (group A, N= 43) or TACE alone (group B, N =42). The study protocol was approved by the institutional ethics committee, and informed consent was obtained from each patient. The primary end point was survival time. Statistical analysis was performed using Kaplan-Meier estimator with log-rank testing, chi-squared, and independent t-tests.Results:The mean and median survival times were 221.7±16.3 d [95% confidence interval (CI):(189.8-253.6) d] and 210.0±17.5 d [95% CI:(175.8-244.2) d] in group Aand 155.1±7.9 d [95% CI:(139.6-170.5) d] and 154.0±11.2 d [95% CI: (133.2-176.0) d] in group B (P=0.000). The 90-,180-,360-day cumulative survival rates were 97.6%,58.9% and 12.3% in group A and 92.5%,30.7% and 0% in group B(P= 0.000).Conclusion:TACE combined with endovascular implantation of iodine-125 seed strand is feasible, safe and effective in the treatment of HCC with PVTT. |
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