• Medicine · Sep 2017

    Randomized Controlled Trial

    Combination of transcatheter arterial chemoembolization and interrupted dosing sorafenib improves patient survival in early-intermediate stage hepatocellular carcinoma: A post hoc analysis of the START trial.

    • Teng-Yu Lee, Chen-Chun Lin, Chiung-Yu Chen, Tsang-En Wang, Gin-Ho Lo, Chi-Sen Chang, and Yee Chao.
    • aDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital bDepartment of Medicine, Chung Shan Medical University, Taichung cDivision of Hepatology, Liver Research Unit, Department of Gastroenterology and Hepatology, Linkou Chang Gung Memorial Hospital-Chang Gung University, Linkou dNational Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan eMackay Memorial Hospital, Taipei fDepartment of Medical Research, E-Da Hospital, School of Medicine for International Students, I-Shou University, Kaohsiung gDepartment of Oncology, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.
    • Medicine (Baltimore). 2017 Sep 1; 96 (37): e7655.

    Background/ObjectiveThe survival benefit of treatment for unresectable hepatocellular carcinoma (HCC) with transcatheter arterial chemoembolization (TACE) combined with sorafenib remains uncertain. We compared the survival of patients treated with TACE and sorafenib with that of patients treated with TACE alone.MethodsThis was a post hoc analysis of the Study in Asia of the Combination of TACE with Sorafenib in Patients with HCC (START) trial. All patients who received TACE and interrupted dosing of sorafenib for early or intermediate-stage HCC in Taiwan from 2009 to 2010 were recruited into the TACE and sorafenib group. They were randomly matched 1:1 by age, sex, Child-Pugh score, tumor size, tumor number, and tumor stage with patients from Taichung Veterans General Hospital in Taiwan who received TACE alone and who fulfilled the selection criteria of the START trial during the same time period (control group). Patient survival [cumulative incidence and hazard ratio (HR)] of the 2 groups were analyzed and compared.ResultsThe baseline characteristics of the 36 patients in each group were similar. Tumor response rates were significantly better in the TACE and sorafenib group (P < .04). Overall survival of the TACE and sorafenib group was also significantly better than that of the control (TACE alone) group over the 2 years [78%, 95% confidence interval (95% CI) 64-91 vs 49, 95% CI 32-66; P = .012]. In the multivariate regression analysis, TACE and sorafenib was found to be independently associated with a decreased risk of mortality (HR 0.33, 95% CI 0.12-0.89; P = .015). Multivariate stratified analyses verified this association in each patient subgroup (all HR < 1.0).ConclusionWith a high patient tolerance to an interrupted sorafenib dosing schedule, the combination of TACE with sorafenib was associated with improved overall survival in early-intermediate stage HCC when compared with treatment with TACE alone.

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