131I Lipiodol therapy for unresectable hepatocellular carcinoma

Background: More than 80% of hepatocellular carcinoma tumours (HCC) are unresectable at presentation because of the multicentric nature of the disease or the severity of liver disease. Arterially administered lipiodol is preferentially retained by HCC and has been used as a vehicle for delivery of therapeutic agents to the tumour. The aim of this phase I study is to present the experience with 1 3 1 I-labelled lipiodol in the treatment of unresectable HCC. Methods: 1 3 1 Iodine lipiodol treatment was administered to 12 patients with unresectable HCC between 1994 and 1999. The outcome of treatment in these patients was evaluated for survival, clinical tolerance, liver function tests, α-fetoprotein (AFP) levels and changes in tumour size on computed tomography (CT) scans. Results: Ten of the 12 patients received more than one 1 3 1 I treatment. Five patients had treatment for post-resection recurrence. Serum AFP levels dropped initially in five of the seven patients with elevated values. Tumour size, evaluated by CT scans at 3 months, decreased in six patients and remained stable in the rest, except one patient in whom both the AFP level and tumour size had increased. Using life table analysis, the 50% survival was 19 months. Conclusions: Intra-arterial 1 3 1 I treatment was very well tolerated. A reduction in AFP levels and tumour size occurred in half of the patients and resulted in a 50% probability of survival of 19 months. Further examination of the value of this treatment in phase II and III studies is required.