COMPARISON OF LIPIODOL CHEMOEMBOLIZATION AND CONSERVATIVE TREATMENT FOR UNRESECTABLE HEPATOCELLULAR-CARCINOMA

Background. Chemoembolization with Lipiodol (iodized oil) is widely us ed to treat patients with unresectable hepatocellular carcinoma, Sever e side effects have been reported, and improved survival has not been clearly demonstrated. Methods. Patients with unresectable hepatocellul ar carcinoma who did not have severe liver disease and who met additio nal entry criteria were randomly assigned to receive either Lipiodol c hemoembolization (70 mg of cisplatin, 10 ml of Lipiodol, and gelatin-s ponge [Gelfoam] particles delivered through the hepatic artery) or con servative management involving treatment of complications and pain, Co urses of treatment were to be given every two months for a maximum of four courses, The main end point was survival. Results. The study was stopped in December 1992, after a sequential analysis showed the lack of the expected benefit from chemoembolization. As of October 1, 1994, 39 of the 50 patients assigned to chemoembolization and 40 of the 46 patients assigned to conservative management had died. Twenty-six pati ents assigned to chemoembolization received all four courses of treatm ent. There was no significant difference in survival between the two g roups, although there was a trend favoring the chemoembolization group (estimated relative risk of death in the control group, 1.4, 95 perce nt confidence interval, 0.9 to 2.2; P = 0.13). The comparison of survi val between the two groups was not substantially changed by adjustment s for differences in base-line and prognostic characteristics (adjuste d relative risk, 1.3; 95 percent confidence interval, 0.8 to 2.1; P = 0.31). At one year, the estimated survival rates were 62 percent in th e chemoembolization group (95 percent confidence interval, 48.6 to 75. 4 percent) and 43.5 percent in the conservative-management group (95 p ercent confidence interval, 29.2 to 57.8 percent). In the chemoemboliz ation group, tumor growth, as assessed by tumor size and serum alpha-f etoprotein concentration, was reduced and the incidence of portal obst ruction was lower than in the conservative-management group. Liver fai lure occurred after 47 courses of treatment in 30 patients assigned to chemoembolization. Conclusions. In a group of patients with unresecta ble hepatocellular carcinoma but without severe liver disease, Lipiodo l chemoembolization reduced tumor growth, often caused acute liver fai lure, and did not significantly improve survival.