OBJECTIVETo evaluate the effects of autologous tumor vaccines in preventing recurrences of hepatocellular carcinoma (HCC).

METHODSFrom March 1999 to June 2003, 80 patients with HCC undergoing resections were randomly assigned into a tumor vaccine group (n=40) and a control group (n=40). Tumor vaccines, consisting of formalin-fixed HCC tissue fragments, biodegradable sustained-releasers of granulocyte-macrophage-colony stimulating factor, interleukin-2, and an adjuvant, were developed. Every vaccine group patient received 3 vaccinations at a 2-week interval and the control group just received the adjuvant. Delayed-type-hypersensitivity (DTH) test and recurrent rates were analyzed.

RESULTSEight patients of the vaccine group and five patients of the control group were lost in the follow-up. Thirty-two patients completed the tumor vaccine procedure and no essential adverse effects occurred. 23/32 patients developed DTH responses against the fragments of HCC. The follow-up averaged 34.3 months (from 15 to 55 months). 1-, 2-, 3-year recurrence rates of the vaccine group were 12.6%, 35.9% and 54.0%, respectively; 1-, 2-, 3-year recurrence rates of the control group were 31.6%, 61.3% and 72.1%, respectively. The recurrent rate was significantly better in the tumor vaccine group than in the control group (P = 0.037).

CONCLUSIONSAutologous tumor vaccine is a promising adjunctive modality to prevent recurrence of human HCC.