Adjuvant Intraarterial Lipiodol or 131 I-Lipiodol After Curative Treatment of Hepatocellular Carcinoma: A Prospective Randomized Trial

The prevention of tumor recurrence after curative treatment of hepatocellular carcinoma (HCC) is unresolved. Postoperative intraarterial injection of 131 I-labeled lipiodol has been proposed as adjuvant treatment. The aim of this prospective randomized trial was to evaluate if a single dose of postoperative adjuvant intraarterial 131 I-lipiodol (vs. unlabeled lipiodol) could reduce the rate of intrahepatic recurrence at 2 y. Methods: Patients who underwent curative treatment for HCC and recovered within 6 wk were randomly assigned to receive a single 2,200-MBq 131 I-lipiodol dose or a single unlabeled lipiodol dose on a 1:1 basis. Recurrence-free and overall survival rates were analyzed. Results: Between June 2005 and February 2009, we included 58 patients (median age of 63 y [range, 23–85 y]): 29 received intraarterial 131I-lipiodol and 29 received lipiodol adjuvant treatment. At 2 y after treatment, the rate of patients with intrahepatic recurrence was 28% in the 131I-lipiodol group and 56% in the lipiodol group (P 5 0.0449). The Kaplan–Meier analysis confirmed this result, with a 2-y recurrence-free survival in the 131I-lipiodol and lipiodol groups of 73% and 45%, respectively (P 5 0.0259). The 5-y recurrence-free survival rates in the 131I-lipiodol and lipiodol groups were 40% and 0%, respectively (P 5 0.0184). The overall and specific survivals were not significantly different between groups (P 5 0.9378 and P 5 0.1339, respectively). 131I-lipiodol had no severe toxic effects. Conclusion: After curative treatment of patients with HCC, one 2,200-MBq dose of intraarterial 131 I-lipiodol significantly