CLINICAL-STUDY OF BIOLOGICAL RESPONSE MODIFIERS AS MAINTENANCE THERAPY FOR HEPATOCELLULAR-CARCINOMA

We conducted a randomized, controlled trial comparing 5-fluorouracil ( 5-FU) with or without biological response modifiers (BRMs) as a mainte nance therapy for hepatocellular carcinoma (HCC) after treatment with percutaneous ethanol injection (PEI), transcatheter arterial embolizat ion (TAE) or arterial infusion of antitumor agents (AI). A total of 58 cases of HCC were classified into 4 groups as follows: group I, PSK w ith 5-FU (n = 15); group II, lentinan with 5-FU (n = 15); group III, O K-432 with 5-FU (n = 12); and group IV, 5-FU alone as the control (n = 16). The mean survival time, mortality rate, time to progression, and T-4/T-8 ratio of lymphocytes in the peripheral blood were compared am ong the four groups. There was no significant difference in the backgr ound factors among the groups. In group I, the T-4/T-8 ratio of lympho cytes was reduced after the therapy. No significant difference was fou nd among the groups in terms of the mean survival time, mortality rate , or time to progression. PEI for initial therapy was superior to the other therapies in terms of the mean survival time and mortality rate. These results suggest that the addition of BRM to maintenance therapy with 5-FU exerts no prognostic benefit on HCC patients treated with P EI, TAE, or AI.