Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial.

BACKGROUND/AIMS: Recurrence after resection of hepatocellular carcinoma (HCC) is a frequent event. This study evaluated the effect of postoperative interferon alpha (IFN alpha) treatment on recurrence and survival in patients with hepatitis B virus (HBV)-related HCC.

METHOD

Two hundred and thirty six patients were randomized after resection into IFN alpha treatment (5 micro i.m. tiw for 18 months) and control groups. Treatment was terminated if recurrence was diagnosed, and recurrence was managed the same way in both groups. Statistical analysis was based on the method of intent-to-treat.

RESULTS

The two groups were comparable in all clinicopathological parameters. The median overall survival was 63.8 months in the treatment group and 38.8 months in the control group (P=0.0003); the median disease-free survival period was 31.2 versus 17.7 months (P=0.142). Fever, leucocytopenia, and thrombocytopenia were adverse effects in the treatment group, but were mostly manageable.

CONCLUSIONS

IFN alpha treatment improved the overall survival of patients with HBV-related HCC after curative resection, probably by postponing recurrence.