BACKGROUND, Hepatocellular carcinoma (HCC) is the third most common cause of cancer mortality worldwide. Survival is poor for patients with advanced-stage HCC, and small trials of tamoxifen for patients with this disease have shown conflicting results. The authors conducted a systematic review of randomized clinical trials to compare the effect of a tamoxifen-containing arm with a nontamoxifen-containing arm in advanced HCC.
METHODS. Eligible trials were identified from the Cochrane Hepato-Biliary Group register and other databases. Studies were selected for inclusion and their methodologic quality assessed by three independent reviewers. Hazard ratios (HR) were derived for overall survival where possible. Metaanalysis was performed using a fixed-effect model.
RESULTS. The authors identified 10 randomized trials with a total of 1709 patients. Use of tamoxifen had no effect on median survival (HR, 1.05; 95% confidence interval, 0.94-1.16; P = 0.4) or tumor response rate. The findings were stable in sensitivity analyses and were not affected by publication bias or inclusion of low-quality studies or studies reported in abstract form only. Few adverse events or withdrawals were noted.
CONCLUSIONS. There was no support for the therapeutic use of tamoxifen in advanced HCC, nor for its use as a control arm in future clinical trials. (c) 2005 Ainerican Cancer Society.