Efficacy of Transcatheter Arterial Chemoembolization Combined Thalidomide on Hepatocellular Carcinoma: A Controlled Randomized Trial
HAO Ming-Zhi1, LIN Hai-Lan1, CHEN Qiang2, WU Hui2, YU Wen-Chang1, CHEN Tang-Geng1 1. Department of Interventional Radiology, Fujian Provincial Tumor Hospital, Fuzhou, Fujian, 350014, P. R. China 2. Department of Medical Oncology, Fujian Provincial Tumor Hospital, Fuzhou, Fujian, 350014, P. R. China
BACKGROUND OBJECTIVE: Transcatheter arterial chemoembolization (TACE) is an important therapy for hepatocellular carcinoma (HCC), but the recurrence rate is still high and the long-term survival is unsatisfactory. This study was to evaluate the efficacy of TACE combined thalidomide on HCC. METHODS: From Aug. 2004 to Aug. 2006, 108 patients with unresectable primary HCC were randomized into combination (TACE plus thalidomide) group and TACE group. Combination group received oral administration of thalidomide (200 mg/d) for 1-6 months. Both groups were treated with 0.4-1.6 g gemcitabine, 100-200 mg oxaliplatin, and 0.5-1.0 g floxuridine as chemotherapeutic drugs, ethanol, glutin, and iodolipol as ambolic agent in TACE. The side effects of thalidomide and survival of the patients were observed. RESULTS: The median survival period was 18 months [95% confidence interval (CI), 12-24 months] in combination group and 13 months (95% CI, 10-16 months) in TACE group. The 6-month, 1-year, and 2- year survival rates were 92.9%, 82.7%, and 58.4% respectively in combination group, and 85.6%, 57.2%, and 32.3% respectively in TACE group. The median time to progression was significantly longer in combination group than in TACE group [181 days (95% CI, 91-271 days) vs. 97 days (95% CI, 33-161 days), P0.05]. Excluding the patients who took thalidomide for less than 1 month, the median survival period was significantly longer in combination group than in TACE group [18 months (95% CI, 12-24 months) vs. 13 months (95% CI, 10-16 months), P0.05]; the 6-month, 1-year, and 2- year survival rates were 96.6%, 70.8%, and 44.3% respectively in combination group, and 84.7%, 54.4%, and 14.9% respectively in TACE group. The occurrence rate of serious rashes was 11.1% and that of serious somnolency was 6.7%. Multivariate Cox analysis showed that the times of TACE was an independent prognostic factor of HCC. CONCLUSIONS: Compared with TACE alone, the combination of TACE and thalidomide can obviously postpone disease progression and prolong survival of HCC patients. The times of TACE is a prognostic factor of HCC after TACE.