Journal of Gastroenterology and Hepatology · 2009 · 27 citations · 33 references
PharmacyOncologyPharmacotherapyCancer PharmacologyHepatic PharmacotherapyImmunotherapyAntiviral TherapyHepatocellular Carcinoma PharmacotherapyInterferon-based TherapyTreatment DurationViral HepatitisViral Hepatitis TreatmentCombination TherapyHepatitis B Virus ManagementInterferon Alfa TherapyIntramuscular Injection TechniqueOverall MortalityRecurrenceRecurrence Rate Analysis
BACKGROUND AND AIMS: The present study was carried out to test the hypothesis that interferon-alpha (IFN-alpha) treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after transarterial chemoembolization (TACE) treatment of hepatitis B virus (HBV) related unresectable hepatocellular carcinoma (HCC). METHODS: 216 patients with unresectable HBV-related HCC were randomized into a TACE group and a TACE-IFN group, each group had 108 patients. In the TACE-IFN group, patients received IFN-alpha1b at a dose of 3 million units (mu) three times a week by intramuscular injection one week after/before TACE treatment, for 48 weeks. RESULTS: The median disease-free survival in the TACE-IFN treatment group was 23.6 months (95% CI: 21.4-25.8) and 20.3 months (95% CI: 15.8-24.8) in the TACE group (P = 0.027). The disease free rate at 24 months in the TACE group was lower than in the TACE-IFN group (39.8% vs 59.3%, P = 0.004). The median overall survival was 29 months (95% CI: 27.5-32.1) in the TACE-IFN group and 26 months (95% CI: 20.1-31.9) in the TACE group (P = 0.003). The 2-year overall survival in the TACE-IFN group was higher than in the TACE group (72.2% vs 52.8%, P = 0.003). CONCLUSIONS: IFN-alpha treatment reduced recurrence and improved the survival of patients after TACE treatment of HBV-related HCC, with acceptable toxicities.
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Josep M. Llovet, Andrew K. Burroughs, Jordi Bruix · The Lancet · 2003 · 3.6K citations
Power and sample size calculations
William D. Dupont, W. Dale Plummer · Controlled Clinical Trials · 1990 · 2.1K citations
Kunio Okuda, Toshio Ohtsuki, Hiroshi Obata et al. · Cancer · 1985 · 1.9K citations · Full text