Affiliation:
1. From the Centre Hospitalier, Compiègne; Centre Hospitalo-Universitaire, Reims; Institut National de la Santé et de la Recherche Médicale, Equipe Mixte INSERM 106, Dijon; Centre Eugène Marquis, Rennes; Centre Hospitalo-Universitaire Ambroise Paré, Assistance Publique Hôpitaux de Paris; Centre Hospitalo-Universitaire, Clermont Ferrand; Institut Gustave Roussy, Villejuif; Centre Hospitalier Régional, Colmar; Centre Hospitalier Régional, Le Mans; Centre Hospitalier Régional, Pau; Fédération Francophone de...
Abstract
Purpose Randomized studies on tamoxifen treatment of hepatocellular carcinoma (HCC) produced conflicting results. The aim of this study was to assess the efficacy of tamoxifen administration in improving overall survival of patients with advanced HCC. Patients and Methods A total of 420 patients with HCC who were not suitable for surgery or local treatment were randomly assigned between April 1995 and May 2000: 210 in the control group and 210 in the tamoxifen group (20 mg/d orally). Patients with WHO performance status greater than 2, belonging to Child-Pugh class C, or with serum creatinine greater than 130 μmol/L were not eligible. Results Tolerance was good and the main reported adverse effects were thrombophlebitis (three patients), nausea (two patients), and hot flushes (three patients). Outcome did not differ between the two treatment arms: estimated median survival was 4.8 and 4.0 months in the tamoxifen and in the control groups, respectively (P = .25). Univariate analysis showed significant association of survival with age, Okuda stage, WHO performance status, Child-Pugh class, intrahepatic tumor stage, alpha-fetoprotein serum concentration, and presence of extrahepatic spread, portal vein thrombosis, hepatomegaly, or hepatalgia. In a Cox proportional hazards model we found a significant beneficial effect of tamoxifen on survival in patients belonging to Okuda I or II stages. Conclusion In this large study, tamoxifen did not improve the survival of patients with advanced HCC, but there is a suggestion that patients without major hepatic insufficiency seem to have some survival benefit. New trials involving this specific population are warranted.
Publisher
American Society of Clinical Oncology (ASCO)
Reference33 articles.
1. Estimating the world cancer burden: Globocan 2000
2. The Continuing Increase in the Incidence of Hepatocellular Carcinoma in the United States: An Update
3. Remontet L, Estève J, Bouvier A-M, et al: Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sant é Publique 51:3,2003-30,
4. Hepatocellular carcinoma
5. Clavière C, Bronowicki JP, Hudziak H, et al: Roles of sex steroids and their receptors in the pathophysiology of hepatocellular carcinoma. Gastroenterol Clin Biol 22:73,1998-86,
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