Background Chemoembolization with Lipiodol (iodized oil) iswidely used to treat patients with unresectable hepatocellularcarcinoma. Severe side effects have been reported, and improvedsurvival has not been clearly demonstrated.
Methods Patients with unresectable hepatocellular carcinomawho did not have severe liver disease and who met additionalentry criteria were randomly assigned to receive either Lipiodolchemoembolization (70 mg of cisplatin, 10 ml of Lipiodol, andgelatin-sponge [Gelfoam] particles delivered through the hepaticartery) or conservative management involving treatment of complicationsand pain. Courses of treatment were to be given every two monthsfor a maximum of four courses. The main end point was survival.
Results The study was stopped in December 1992, after a sequentialanalysis showed the lack of the expected benefit from chemoembolization.As of October 1, 1994, 39 of the 50 patients assigned to chemoembolizationand 40 of the 46 patients assigned to conservative managementhad died. Twenty-six patients assigned to chemoembolizationreceived all four courses of treatment. There was no significantdifference in survival between the two groups, although therewas a trend favoring the chemoembolization group (estimatedrelative risk of death in the control group, 1.4; 95 percentconfidence interval, 0.9 to 2.2; P = 0.13). The comparison ofsurvival between the two groups was not substantially changedby adjustments for differences in base-line and prognostic characteristics(adjusted relative risk, 1.3; 95 percent confidence interval,0.8 to 2.1; P = 0.31). At one year, the estimated survival rateswere 62 percent in the chemoembolization group (95 percent confidenceinterval, 48.6 to 75.4 percent) and 43.5 percent in the conservative-managementgroup (95 percent confidence interval, 29.2 to 57.8 percent).In the chemoembolization group, tumor growth, as assessed bytumor size and serum alpha-fetoprotein concentration, was reducedand the incidence of portal obstruction was lower than in theconservative-management group. Liver failure occurred after47 courses of treatment in 30 patients assigned to chemoembolization.
Conclusions In a group of patients with unresectable hepatocellularcarcinoma but without severe liver disease, Lipiodol chemoembolizationreduced tumor growth, often caused acute liver failure, anddid not significantly improve survival.
Source Information
Address reprint requests to Dr. Jean-Claude Trinchet at the Service d'Hépato-gastroentérologie, Hôpital Jean Verdier, Ave. du 14 juillet, 93143 Bondy CEDEX, France.
Treatment of Unresectable Hepatocellular Carcinoma
Stuart K., Vauthey J. N., Marsh R. d. W., Davis G. L., Rees C. R., Bismuth H., Samuel D., Engerran L., Trinchet J.-C., Chevret S., Mathieu D., The Groupe d'Etude et de Traitement du Carcinome Hepatocéllulaire
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N Engl J Med 1995;
333:877-878, Sep 28, 1995.
Correspondence
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