Adjuvant Iodine-125 Brachytherapy for Hepatocellular Carcinoma after Complete Hepatectomy: A Randomized Controlled Trial

Background: Tumor recurrence is a major problem after curative resection of hepatocellular carcinoma (HCC). The current study evaluated the effects of adjuvant iodine-125 (I-125) brachytherapy on postoperative recurrence of HCC. Methodology/Principal Findings: From July 2000 to June 2004, 68 HCC patients undergoing curative hepatectomy were randomly assigned into a I-125 adjuvant brachytherapy group (n = 34) and a group of best care (n = 34). Patients in the I-125 adjuvant brachytherapy group received I-125 seed implantation on the raw surface of resection. Patients in the best care control group received identical treatments except for the I-125 seed implantation. Time to recurrence (TTR) and 1-, 3- and 5-year overall survival (OS) were compared between the two groups. The follow-up ended in January 2010, and lasted for 7.7-106.4 months with a median of 47.6 months. TTR was significantly longer in the I-125 group (mean of 60.0 months vs. 36.7 months in the control). The 1-, 3-and 5-year recurrence-free rates of the I-125 group were 94.12%, 76.42%, and 73.65% vs. 88.24%, 50.00%, and 29.41% compared with the control group, respectively. The 1-, 3-and 5-year OS rates of the I-125 group were 94.12%, 73.53%, and 55.88% vs. 88.24%, 52.94%, and 29.41% compared with the control group, respectively. The I-125 brachytherapy decreased the risk of recurrence (HR = 0.310) and the risk of death (HR = 0.364). Most frequent adverse events in the I-125 group included nausea, vomiting, arrhythmia, decreased white blood cell and/or platelet counts, and were generally mild and manageable. Conclusions/Significance: Adjuvant I-125 brachytherapy significantly prolonged TTR and increased the OS rate after curative resection of HCC.