Adjuvant intra-arterial iodine-131-labeled lipiodol for resectable hepatocellular carcinoma: a prospective randomized trial-update on 5-year and 10-year survival.

OBJECTIVE

In this prospective randomized trial, we attempted to find out if 1 dose of postoperative adjuvant intra-arterial iodine-131-labeled lipiodol could reduce the rate of local recurrence, and increase disease-free and overall survival for patients with hepatocellular carcinoma (HCC). This study evaluated the long-term outcome.

BACKGROUND

Resection of HCC is potentially curative, but local recurrence is common. However, there is currently no effective adjuvant therapy. Early results after closing the trial (Lau et al. Lancet 1999;353:797-801) showed that 1 dose of intra-arterial I-lipiodol given after curative resection significantly decreased the rate of recurrence, and increased disease-free and overall survival.

METHODS

Patients who underwent curative resection for HCC and recovered within 6 weeks were randomly assigned one 1850 MBq dose of I-lipiodol or no further treatment (controls). We compared rates of recurrence, and long-term disease-free and overall survival (the primary endpoints) between the 2 groups by intention-to-treat.

RESULTS

Between April 1992 and August 1997, we recruited 43 patients: 21 were randomized to receive intra-arterial I-lipiodol and 22 to receive no adjuvant treatment. I-lipiodol had no significant toxic effects. During a median follow-up of 66 (range, 3-198) months, there were 10 (47.6%) recurrences among the 21 patients in the adjuvant treatment group, compared with 14 (63.6%) in the control group (P = 0.29). The actuarial 5-year disease-free survival in the treatment and control groups was 61.9% and 31.8%, respectively (P = 0.0397). The actuarial 5-year overall survival in the treatment and control groups was 66.7% and 36.4%, respectively (P = 0.0433). The actuarial 7-year disease-free survival in the treatment and control groups was 52.4% and 31.8%, respectively (P = 0.0224). The actuarial 7-year overall survival in the treatment and control groups was 66.7% and 31.8%, respectively (P = 0.0243). The actuarial 10-year disease-free survival in the treatment and control groups was 47.6% and 27.3%, respectively (P = 0.0892). The actuarial 10-year overall survival in the treatment and control groups was 52.4% and 27.3%, respectively (P = 0.0905).

CONCLUSIONS

In patients with HCC, adjuvant intra-arterial I-lipiodol after curative liver resection provided survival benefit on the disease-free survival and overall survival, although the difference became statistically insignificant at 8 years after randomization.