Randomized controlled trial of interferon treatment for advanced hepatocellular carcinoma

Authors

  • Josep M. Llovet,

    1. Liver Unit BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Margarita Sala,

    1. Liver Unit BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Lluís Castells,

    1. Liver Unit, Hospital Vall d'Hebrón, Catalonia, Spain
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  • Yanette Suarez,

    1. Liver Unit BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Ramon Vilana,

    1. Radiology Department, BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Lluís Bianchi,

    1. Radiology Department, BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Carmen Ayuso,

    1. Radiology Department, BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Víctor Vargas,

    1. Liver Unit, Hospital Vall d'Hebrón, Catalonia, Spain
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  • Joan Rodés,

    1. Liver Unit BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
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  • Jordi Bruix M.D.

    Corresponding author
    1. Liver Unit BCLC (Barcelona-Clínic Liver Cancer) Group, IDIBAPS (Institut d'Invertigacions Biomèdiques August Pi i Sunyer) Hospital Clínic Barcelona, Barcelona, Spain
    • Liver Unit, Hospital Clínic, Villarroel 170, 08036-Barcelona, Catalonia, Spain
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Abstract

The aim of this randomized controlled trial was to assess the efficacy of interferon alfa–2b (IFN) for the treatment of advanced hepatocellular carcinoma (HCC). Fifty-eight patients with HCC who were not suitable for resection, transplantation, ethanol injection, or arterial embolization were stratified according to their Okuda stage and randomized to receive IFN (3 × 106, 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, presence of constitutional syndrome, Child-Pugh class, Okuda stage, multinodularity, portal thrombosis, and extrahepatic spread. Adhesion to IFN treatment was adequate in 27 patients, with a mean duration of treatment of 8 ± 3 months. However, IFN treatment was associated with side effects in 23 patients, leading to treatment discontinuation in 13 patients. Two of the 30 patients (6.6%) presented a partial response with greater than 50% size reduction and normalization of α-fetoprotein levels. The survival at 1 and 2 years 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 according to their Okuda stage. The probability of presenting tumor progression (P = .17), or deterioration of Child-Pugh class (P= .37), performance status (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.

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