Background Internal irradiation with iodine-131 (¹³¹I)-labeled Lipiodol is one of the currently available forms of palliative therapy for patients with advanced hepatocellular carcinoma (HCC). Despite a cumulative experience of more than 10 years with this treatment, only a few studies have reported on its efficacy and safety. Objective The aim of this study was to retrospectively evaluate the efficacy of intra-arterial ¹³¹I-labeled Lipiodol injection for treatment against advanced HCC. Materials and methods Fifty patients (47 men and three women; mean age 64 years) given an intra-arterial injection of ¹³¹I-Lipiodol (5 ml of 2.2 GBq Lipiodol labeled with ¹³¹I; number of mean sessions per patient, 1.3; range 1–4) were retrospectively compared with 36 patients (31 men and five women; mean age 64 years) who were given only medical support. Portal vein thrombosis was present in 86 and 100% of patients, respectively. Efficacy was determined on the basis of overall survival as the endpoint using the Kaplan–Meier method. Tumor response was evaluated with computed tomography according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) and European Association for the Study of the Liver (EASL) criteria. Results For patients treated with ¹³¹I-Lipiodol, median survival was 32 weeks, compared with 8 weeks for the untreated group (P=0.007). Survival at 6 months and at 1 and 2 years was 65, 35, and 22%, respectively, for patients treated with ¹³¹I-Lipiodol compared with 28, 8, and 0% for the untreated group. At 1 month, more than 80% of patients were responders (complete response, partial response, and stable disease) on the basis of the RECIST and EASL criteria, and at 6 months 39% were responders. No radiotoxic effect was observed, especially with respect to interstitial pneumonia. No significant difference was observed between survival and α-fetoprotein levels, Barcelona Clinic Liver Cancer clinical score, and portal vein thrombosis. Conclusion Intra-arterial injection of ¹³¹I-Lipiodol is safe and provides significant survival benefit in terms of overall survival for patients with advanced HCC.

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