Thirty-six consecutive patients with advanced hepatocellular carcinoma
and chronic liver disease were randomly allocated to two groups: grou
p I included 20 patients who were treated with 10 mg bid. tamoxifen an
d group II with 16 nontreated patients. The two groups were homogeneou
s according to clinical and analytical data. Survival curves in the ta
moxifen-treated patients improved significantly when compared with the
non-treated group (p=0.01). Cumulative survival at the end of the fir
st year was 48.5% in the treated patients and 9.1% in controls. Median
survival was 261 days in the treated group vs. 172 in the non-treated
group (p<0.05). Complications of cirrhosis and worsening of the perfo
rmance status test occurred less in the treated patients than in the c
ontrols, but not significantly so. Tamoxifen was well tolerated and no
marked side effects were observed. In this series, tamoxifen improved
survival in patients with advanced hepatocellular carcinoma. (C) Jour
nal of Hepatology.