Lancet. 1998 Jul 4;352(9121):17-20.
Results from small randomised trials on tamoxifen in the treatment of hepatocellular carcinoma (HCC) are conflicting. We studied whether the addition of tamoxifen to best supportive care prolongs survival of patients with HCC.
Patients with any stage of HCC were eligible, irrespective of locoregional treatment. Randomisation was centralised, with a minimisation procedure accounting for centre, evidence of disease, and time from diagnosis. Patients were randomly allocated best supportive care alone or in addition to tamoxifen. Tamoxifen was given orally, 40 mg per day, from randomisation until death.
496 patients from 30 institutions were randomly allocated treatment from January, 1995, to January, 1997. Information was available for 477 patients. By Sept 15, 1997, 119 (50%) of 240 and 130 (55%) of 237 patients had died in the control and tamoxifen arms, respectively. Median survival was 16 months and 15 months (p=0.54), respectively. No differences were found within subgroups defined by prognostic variables. Relative hazard of death for patients receiving tamoxifen was 1.07 (95% CI 0.83-1.39).
Our findings show that tamoxifen is not effective in prolonging survival of patients with HCC.
关于他莫昔芬治疗肝细胞癌（HCC）的小型随机试验结果相互矛盾。我们研究了在最佳支持治疗基础上加用他莫昔芬是否能延长HCC患者的生存期。
任何阶段的HCC患者均符合条件，无论其局部区域治疗情况如何。随机分组采用集中式，通过最小化程序考虑中心、疾病证据和诊断后的时间。患者被随机分配接受单纯最佳支持治疗或在最佳支持治疗基础上加用他莫昔芬。从随机分组至死亡，他莫昔芬每日口服40mg。
1995年1月至1997年1月，来自30个机构的496例患者被随机分配接受治疗。477例患者有可用信息。至1997年9月15日，对照组240例患者中有119例（50%）死亡，他莫昔芬组237例患者中有130例（55%）死亡。中位生存期分别为16个月和15个月（p=0.54）。在根据预后变量定义的亚组中未发现差异。接受他莫昔芬治疗患者的死亡相对风险为1.07（95%CI 0.83-1.39）。
我们的研究结果表明，他莫昔芬对延长HCC患者的生存期无效。
