Nowak Anna K, Stockler Martin R, Chow Pierce K H, Findlay Michael
National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.
Cancer. 2005 Apr 1;103(7):1408-14. doi: 10.1002/cncr.20963.
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.
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.
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.
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.
肝细胞癌（HCC）是全球癌症死亡的第三大常见原因。晚期HCC患者的生存率较低，针对该疾病患者的他莫昔芬小型试验结果相互矛盾。作者对随机临床试验进行了系统评价，以比较含他莫昔芬组与不含他莫昔芬组在晚期HCC中的疗效。
从Cochrane肝胆疾病小组登记册和其他数据库中识别符合条件的试验。由三名独立评审员选择纳入研究并评估其方法学质量。尽可能得出总生存的风险比（HR）。采用固定效应模型进行荟萃分析。
作者识别出10项随机试验，共1709例患者。使用他莫昔芬对中位生存期（HR，1.05；95%置信区间，0.94 - 1.16；P = 0.4）或肿瘤缓解率无影响。在敏感性分析中，结果稳定，不受发表偏倚、纳入低质量研究或仅以摘要形式报告的研究影响。观察到的不良事件或退出情况较少。
不支持在晚期HCC中使用他莫昔芬进行治疗，也不支持在未来临床试验中将其用作对照臂。
