Jérôme Dumortier1, Evelyne Decullier2, Marie-Noëlle Hilleret3, Sylvie Bin-Dorel2, Pierre-Jean Valette4, Olivier Boillot4, Christian Partensky4, Christian Letoublon5, Christian Ducerf6, Vincent Leroy7, Jean-Philippe Vuillez8, Françoise Borson-Chazot9. 1. Hospices Civils de Lyon, Hôpital Edouard Herriot, Fédération des Spécialités Digestives, Lyon, France Université Lyon 1, Lyon, France jerome.dumortier@chu-lyon.fr. 2. Hospices Civils de Lyon, Unité de Recherche Clinique, Pôle IMER, Lyon, France EAM Santé Individu Société 4128, Lyon, France. 3. Service d'Hépato-Gastro-Entérologie, CHU de Grenoble, Hôpital A. Michallon, La Tronche, France. 4. Hospices Civils de Lyon, Hôpital Edouard Herriot, Fédération des Spécialités Digestives, Lyon, France Université Lyon 1, Lyon, France. 5. Service de Chirurgie Digestive, CHU de Grenoble, Hôpital A. Michallon, La Tronche, France Université Joseph Fourier, Grenoble, France. 6. Université Lyon 1, Lyon, France Service de Chirurgie Digestive, Hospices Civils de Lyon, Hôpital de la Croix-Rousse, Lyon, France. 7. Service d'Hépato-Gastro-Entérologie, CHU de Grenoble, Hôpital A. Michallon, La Tronche, France Université Joseph Fourier, Grenoble, France. 8. Université Joseph Fourier, Grenoble, France Service de Médecine Nucléaire, CHU de Grenoble, Hôpital A. Michallon, La Tronche, France; and. 9. Université Lyon 1, Lyon, France Service de Médecine Nucléaire, Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France.
Abstract
UNLABELLED: 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 (131)I-lipiodol and 29 received lipiodol adjuvant treatment. At 2 y after treatment, the rate of patients with intrahepatic recurrence was 28% in the (131)I-lipiodol group and 56% in the lipiodol group (P = 0.0449). The Kaplan-Meier analysis confirmed this result, with a 2-y recurrence-free survival in the (131)I-lipiodol and lipiodol groups of 73% and 45%, respectively (P = 0.0259). The 5-y recurrence-free survival rates in the (131)I-lipiodol and lipiodol groups were 40% and 0%, respectively (P = 0.0184). The overall and specific survivals were not significantly different between groups (P = 0.9378 and P = 0.1339, respectively). (131)I-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 decreased the rate of intrahepatic recurrence but failed to improve overall or specific survival.
RCT Entities:
UNLABELLED: 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 (131)I-lipiodol and 29 received lipiodol adjuvant treatment. At 2 y after treatment, the rate of patients with intrahepatic recurrence was 28% in the (131)I-lipiodol group and 56% in the lipiodol group (P = 0.0449). The Kaplan-Meier analysis confirmed this result, with a 2-y recurrence-free survival in the (131)I-lipiodol and lipiodol groups of 73% and 45%, respectively (P = 0.0259). The 5-y recurrence-free survival rates in the (131)I-lipiodol and lipiodol groups were 40% and 0%, respectively (P = 0.0184). The overall and specific survivals were not significantly different between groups (P = 0.9378 and P = 0.1339, respectively). (131)I-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 decreased the rate of intrahepatic recurrence but failed to improve overall or specific survival.