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Prospective Randomized Controlled Study of Transarterial Chemoembolization with Doxorubicin versus Doxorubicin/Lobaplatin/Mitomycin Combination for Unresectable Hepatocellular Carcinoma

SHI Ming,CHEN Ji’an,LIN Xiaojun,CHEN Minshan,GUO Rongping,LI Shengping,LI JinqingDepartment of Hepatobiliary Oncology,Cancer Center of Sun Yat-sen University,Guangzhou 510060,China  
Objective:Transarterial chemoembolization(TACE)is recommended as the first line therapy for patients with unresectable hepatocellular carcinoma(HCC).This study was designed to evaluate the effect of transarterial chemoembolization with Doxorubicin versus Doxorubicin/Lobaplatin/Mitomycin combination therapy on the survival of patients with unresectable hepatocellular carcinoma.Methods:A total of 94 patients with unresectable large HCC and preserved liver function were randomly assigned to be treated with Doxoru-bicin alone(Group A)or Doxorubicin in combination with Lobaplatin and Mitomycin(Group B).After injection of the anticancer drug(s)mixed with lipiodol,gelfoam was injected to fully obstruct the hepatic artery.The primary objective was to increase survival and secondary objectives were improved response rate and decreased toxicity.The survival rates were obtained by Life Table method.Median survival times were obtained by Kaplan-Meier method and compared by log-rank test.The multivariate analysis was performed using Cox proportional hazards model.Results:The median and 3-,6-,9-,12-,15-,and 18-month survival rates in Group A were 15.9 months,91%,79%,75%,61%,51%,and 31%,respectively.The median and 3-,6-,9-, 12-,15-,18-month survival rates in Group B were 5.0 months,78%,47%,35%,24%,24%,and 24%,respectively.Multivariate analysis showed that the different regimens and portal vein embolus were independent prognostic factors.Severe toxic responses including acute renal failure,Ⅲdegree myelosuppression and ab- dominal infection were observed,without TACE-related death.Conclusion:Patients with unresectable largeHCC and preserved liver function can be treated with TACE.A doxorubicin regimen can achieve better survival than Doxorubicin in combination with Lobaplatin and Mitomycin.
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