Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: a prospective randomised trial

Background Resection of hepatocellular carcinoma is potentially curative, b ut local recurrence is common. In this prospective randomised trial, we aim ed to find out if one dose of postoperative adjuvant intra-arterial iodine- 131-labelled lipiodol could reduce the rate of local recurrence and increas e disease-free and overall survival. Methods Patients who underwent curative resection for hepatocellular carcin oma and recovered within 6 weeks were randomly assigned one 1850 MBq dose o f I-131-lipiodol or no further treatment (controls). We compared rates of r ecurrence and disease-free and overall survival (the primary endpoints) bet ween the two groups by intention to treat. We planned an interim analysis w hen 30 patients (both groups together) had been followed up for a median of 2 years, with the intention of stopping early if the between-group differe nce in disease-free survival was significant (p=0.029). Findings Between April, 1992, and August, 1997, we recruited 43 patients: 2 1 received intra-arterial I-131-lipiodol and 22 received no adjuvant treatm ent. During a median follow-up of 34.6 (range 14.1-69.7) months, there were six (28.5%) recurrences among the 21 patients in the adjuvant treatment, c ompared with 13 (59%) in the controls (p=0.04). Median disease-free surviva l in the treatment and control groups was 57.2 (0.4-69.7) and 13.6 (2.1-68. 3) months, respectively (p=0.037). 30-year overall survival in the treatmen t and control groups was 86.4% and 46.3%, respectively, (p=0.039). The inte rim analysis showed a significant increase in disease-free survival in the treatment group compared with the controls (p=0.01), so we closed the trial early. I-131-lipiodol had no significant toxic effects. respectively a sig nificant toxic effects. Interpretation In patients with hepatocellular carcinoma, one 1850 MBq dose of intra-arterial I-131-lipiodol given after curative resection significan tly decreases the rate of recurrence and increases disease-free and overall survival.