Randomized controlled trial of tamoxifen versus placebo in inoperable hepatocellular carcinoma.

A randomized controlled trial of tamoxifen (60 mg/die) versus placebo was performed in patients with cirrhosis and advanced inoperable hepatocellular carcinoma. Twenty-two patients were matched and coupled for sex, age, Child-Pugh class and tumour mass and then randomized to tamoxifen or placebo. Median survival was 74 weeks in the tamoxifen group (range 27 to 144 weeks) and 52 weeks in the placebo group (range 4 to 112 weeks). The survival of patients treated with tamoxifen improved significantly compared to the controls (Logrank-test, p = 0.04). These findings suggest that the effect of the antiestrogen tamoxifen is both statistically and clinically significant in increasing survival in patients with advanced hepatocellular carcinoma.