Prospective Randomized Controlled Study of Interferon-Alpha in Preventing Hepatocellular Carcinoma Recurrence after Medical Ablation Therapy for Primary Tumors

BACKGROUND. Hepatocellular carcinoma (HCC) recurrence after ablation therapy for primary tumors is common. METHODS. To evaluate the effectiveness of interferon-alpha (IFN-α) in preventing HCC recurrence, 30 eligible patients were randomized into three groups: 11 patients treated with three mega units (MU) of IFN-α three times weekly for 24 months (IFN-α -continuous group), 9 patients treated with 3 MU of IFN-α daily for 10 days every month for 6 months followed by 3 MU of IFN-α daily for 10 days every 3 months for a further 18 months (IFN-α-intermittent group), and 10 patients who received no IFN-α therapy (control group). The three groups were comparable in terms of etiology, demographics, and laboratory data at entry and HCC characteristics. RESULTS. After a median follow-up of 27 months (range 4-53 months), 9 patients (90%) in the control group and 9 patients (45%) in 2 treatment groups (6 patients in the IFN-α-continuous group and 3 patients in the IFN-α-intermittent group) developed an HCC recurrence (P = 0.021). Cumulative HCC recurrence rates in the IFN-α-intermittent, IFN-α-continuous, and control groups were 22.2%, 27.3%, and 40% at the end of 1 year and 33.3%, 54.6%, and 90% at the end of 4 years (P = 0.0375), respectively (control vs. IFN-α-intermittent group, P = 0.0123; vs. IFN-α-continuous group, P = 0.0822). If both IFN-α groups were combined, the cumulative HCC recurrence rate of the patients treated with IFN-α and the control group was 25% and 40% at the end of 1 year and 47% and 90% at the end of 4 years, respectively (P = 0.0135). CONCLUSIONS. The data suggested that IFN-α therapy may reduce HCC recurrence after medical ablation therapy for primary tumors.