Randomized controlled trial of interferon treatment for advanced hepatocellular carcinoma

The aim of this randomized controlled trial was to assess the efficacy of i nterferon alfa-2b (IFN) for the treatment of advanced hepatocellular carcin oma (HCC). Fifty-eight patients with HCC who were not suitable for resectio n, transplantation, ethanol injection, or arterial embolization were strati fied according to their Okuda stage and randomized to receive IFN (3 x 10(6 ), 3 times a week, for 1 year) (n = 30) or symptomatic treatment (n = 28), Both groups were identical in terms of age, sex, performance status, presen ce of constitutional syndrome, Child-Pugh class, Okuda stage, multinodulari ty, portal thrombosis, and extrahepatic spread. Adhesion to IFN treatment w as adequate in 27 patients, with a mean duration of treatment of 8 +/- 3 mo nths. However, IFN treatment was associated with side effects in 23 patient s, leading to treatment discontinuation in 13 patients. Two of the 30 patie nts (6.6%) presented a partial response with greater than 50% size reductio n and normalization of alpha-fetoprotein levels. The survival at 1 and 2 ye ars according to intention to treat was not different between the 2 groups (58% and 38% vs. 36% and 12%, respectively, Breslow P = .19, log rank P = . 14) and the absence of difference was maintained when dividing patients acc ording to their Okuda stage. The probability of presenting tumor progressio n (P = .17), or deterioration of Child-Pugh class (P = .37), performance st atus (P = .07), or Okuda stage (P = .44) was not modified by IFN treatment. These results indicate that IFN is not properly tolerated in patients with cirrhosis and advanced HCC and that its administration prompts no benefit in terms of tumor progression rate and survival.