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Randomized Controlled Trial for Hepatocellular Carcinoma with Portal Vein Thrombosis: Intra-arterial Iodine-131-Iodized Oil Versus Medical Support

Service de Radiologie, Hôpital Sud
Service d'Hépatogastroentérologie, Clinique des Maladies du Foie and Service de Médecine Nucléaire, Hôpital Pontchaillou, Centre Hospitalier Régional Universitaire 35033 Rennes Cedex, Cis Biointernational Saclay, France

Correspondence: For correspondence or reprints contact: JL Raoul, Service d'Hépatogastroentérologie, Hôpital Pontchaillou, 35033 CHRU Rennes, France.

ABSTRACT

Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma (HCC) and a contraindication for chemoembolization. Intra-arterial injection of ¹³¹I-iodized oil which does not modify arterial flow, is feasible in this condition. The aim of this prospective randomized controlled trial was to compare the efficacy of treatment with radiolabeled oil (treated group) versus medical support (control group) in patients with stage I or II HCC (classification of Okuda) with portal vein thrombosis. Methods: Twenty-seven HCC patients (26 males, 1 female), aged 53–79 yr, with portal vein thrombosis were randomly assigned to Lipiocis® group (n = 14) or Control group (n = 13). Additional injections of radiolabeled oil were given 2, 5, 8 and 12 mo after initial therapy. Medical support treatment consisted of: tamoxifen (n = 5), 5 FU intravenously (n = 1), NSAIDs or corticosteroids (n = 5). Efficacy was evaluated according to survical rate (Kaplan-Meier method; log rank test), AFP serum values (measured at 2, 5, 8 and 12 mo) and angiography. Results: The two groups were comparable (Child's classification, Okuda's classification, liver function tests, location of the thrombus). Tolerance was excellent in the Treated group. The actuarial survival curves were significantly different (p < 0.01) between the two groups, the survival rates (CI 95%) at 3, 6 and 9 mo being 71% (48%–95%), 48% (12%–55%), 7% (1%–31%) for the Treated group; and 10% (1%–33%), 0% and 0% for the Control group. Conclusion: Intra-arterial hepatic injection of ¹³¹I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis.

Key Words: hepatoma • portal vein thrombosis • radionuclide therapy • interventional radiology • iodine-131-labeled iodized oil

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