A PROSPECTIVE RANDOMIZED ADMINISTRATION OF 5'-DEOXY-5-FLUOROURIDINE AS ADJUVANT CHEMOTHERAPY FOR HEPATOCELLULAR-CARCINOMA TREATED WITH TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION

A prospective randomized trial was conducted to evaluate the efficacy of long-term oral administration of low-dose 5'-deoxy-5-fluorouridine (5'-DFUR) as an adjuvant chemotherapy, following transcatheter arteria l embolization (TAE) in 40 patients with hepatocellular carcinoma (HCC ). Forty eligible patients were randomized into two groups: 20 with TA E plus 5'-DFUR (400 mg/day) and 20 with TAE alone. A good necrosis rat e or decrease in size of more than 70% of the original tumor mass was attained in 14 by the TAE plus 5'-DFUR arm, and in 12 by the TAE arm a t 3 months after the first TAE. Although all five patients with HCC an d 70-99% necrosis rate after the first TAE in the TAE alone arm showed a less than 70% necrosis rate at 12 months, four of the seven patient s with a 70-99% necrosis in the TAE plus 5'-DFUR arm retained a necros is of more than 70% at 12 months after the first TAE. The appearance r ate of ascites and/or encephalopathy in patients with chemotherapy was not different from that of patients with TAE alone. One-year survival rates in the TAE plus 5'-DFUR arm and the TAE alone arm were 75.0% an d 85.0%, 2-year rates were 64.2% and 66.2%, and 3-year rates were 64.6 % and 49.7%, respectively. There was no significant difference in the survival curves. In conclusion, adjuvant therapy with 5'-DFUR was well tolerated without significant side effects, and it might maintain a g ood necrosis state of HCC after TAE. In order to confirm a beneficial effect of the chemotherapy on the survival period, a study using more patients and longer observation periods will be required.