Intra-arterial injection of radioactive
Lipiodol has shown promising results in patients with
hepatocellular carcinoma (HCC) and portal obstruction. The aim of this prospective, randomized trial was to compare the efficacy and tolerance of 131I-labeled
Lipiodol and chemoembolization for the treatment of patients with HCC. From September 1990 to September 1993, 142 patients (135 men, 7 women; age: 65 +/- 6.6 years) were randomly assigned to treatment groups and given either
intra-arterial injections of 131I-labeled
Lipiodol (60 mCi; 2.2 GBq) (n = 73) or chemoembolization (70 mg
cisplatin) (n = 69). Subsequent
injections were given at 2, 5, 8, 12, and 18 months.
Tumor response was assessed on the basis of
tumor size and serum
alpha-fetoprotein levels. Patient tolerance was assessed clinically and angiographically. Survival rate was the main end-point. A total of 129 patients (65 in the 131I-labeled
Lipiodol group and 64 in the chemoembolization group) were available for analysis; 13 were excluded, mainly because of portal vein
thrombosis. The two groups were comparable. Actuarial survival curves were not significantly different between the two groups. Overall survival rates at 6 months, 1, 2, 3, and 4 years were 69%, 38%, 22%, 14%, and 10%, and 66%, 42%, 22%, 3%, and 0% in the 131I-labeled
Lipiodol and chemoembolization groups, respectively. Reduction in
tumor size was similar for the two groups, with complete response in 1 and 0 patients and partial response in 15 and 16 patients in the 131I-labeled
Lipiodol and chemoembolization groups, respectively. Tolerance was significantly better in the 131I-labeled
Lipiodol group both clinically (3 severe side effects vs. 29 in the chemoembolization group; P < .001) and angiographically (1 arterial
thrombosis vs. 10 in the chemoembolization group; P < .01). In terms of patient survival and
tumor response, radioactive 131I-labeled
Lipiodol and chemoembolization were equally effective in the treatment of HCC, but tolerance to 131I-labeled
Lipiodol was significantly better.