title: Unresectable hepatocellular carcinoma: a prospective controlled trial with tamoxifen.
abstract: The liver is an estrogen responsive organ. Clinically, estrogens may play a role in the induction of liver tumors and, experimentally, estrogens are involved in the control of hepatocyte proliferation. The results of a prospective controlled clinical trial using an anti-estrogen, tamoxifen, in patients with unresectable hepatocellular carcinoma (HCC) are presented below. Thirty-eight consecutive cirrhotics with HCC were allocated to either 30 mg/day tamoxifen or no treatment. The two groups of patients were matched for mean age, male/female ratio, Child-Pugh risk group, approximate tumor volume (US and/or CT scan) and etiology of the underlying cirrhosis. The drug appeared to have no side effects. Survival was significantly prolonged in tamoxifen-treated patients with 22% (vs. 5%) survival at 12 months. No differences were observed between males and females or alcoholic and non-alcoholic cirrhosis. In 53% of tamoxifen-treated patients the levels of alpha-fetoprotein dropped and, in this subgroup, survival was further prolonged. Tumor volume, lactate dehydrogenase (LDH) and alkaline phosphatase slowly increased, suggesting a slower, but continuous, progression of the disease. In conclusion, anti-estrogen treatment appears effective in the palliation of unresectable or otherwise untreatable HCC. A reduction in alpha-fetoprotein levels appears to be a favorable prognostic index.
authors.affiliation: Divisione di Gastroenterologia, Policlinico Universitario, Padova, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Farinati
authors.forename: M
authors.initials: M
authors.lastname: Salvagnini
authors.forename: N
authors.initials: N
authors.lastname: de Maria
authors.forename: A
authors.initials: A
authors.lastname: Fornasiero
authors.forename: M
authors.initials: M
authors.lastname: Chiaramonte
authors.forename: L
authors.initials: L
authors.lastname: Rossaro
authors.forename: R
authors.initials: R
authors.lastname: Naccarato
mesh_terms: D000368:Aged; D000469:Alkaline Phosphatase / Q000378:metabolism; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality; D005260:Female; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000378:metabolism; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D013629:Tamoxifen / Q000627:therapeutic use*; D000509:alpha-Fetoproteins / Q000378:metabolism
chemical_list: D000509:alpha-Fetoproteins; D013629:Tamoxifen; D007770:L-Lactate Dehydrogenase; D000469:Alkaline Phosphatase