他莫昔芬治疗肝细胞癌：一项针对120例患者的双盲安慰剂对照试验。

Treatment of hepatocellular carcinoma with tamoxifen: a double-blind placebo-controlled trial in 120 patients.

作者信息

Castells A, Bruix J, Brú C, Ayuso C, Roca M, Boix L, Vilana R, Rodés J

机构信息

Liver Unit, Hospital Clínic i Provincial, University of Barcelona, Spain.

出版信息

Gastroenterology. 1995 Sep;109(3):917-22. doi: 10.1016/0016-5085(95)90402-6.

DOI:10.1016/0016-5085(95)90402-6

PMID:7657122

Abstract

BACKGROUND & AIMS: The progression of hepatocellular carcinoma may be influenced by estrogens. This has offered the rationale for evaluating the therapeutic usefulness of estrogen-receptor blockers; it is being debated whether long-term tamoxifen administration improves survival in patients with this neoplasm. The aim of this study was to assess the efficacy of tamoxifen administration in the treatment of hepatocellular carcinoma.

METHODS

One hundred twenty patients with this neoplasm who were not suitable for surgery, ethanol injection, or transarterial embolization were included in a placebo-controlled trial and randomized to tamoxifen, 20 mg/day per os, (group A, n = 58) or placebo (group B, n = 62). Patients with terminal diseases were excluded.

RESULTS

Both groups were similar with regard to sex, age, liver function (Child-Pugh's score, 6.5 +/- 1.4 vs. 6.4 +/- 1.4), baseline performance status, and tumor stage. Tamoxifen had no antitumoral effect with no differences in the survival between groups (1- and 2-year actuarial rate: group A, 51% and 27%; and group B, 43% and 29%; P = 0.75), even when stratifying patients according to baseline status. Furthermore, there were no differences in the probability of disease progression (P = 0.46) and baseline performance status maintenance (P = 0.93) during follow-up.

CONCLUSIONS

Tamoxifen has no efficacy in the treatment of patients with advanced hepatocellular carcinoma.

摘要

背景与目的

肝细胞癌的进展可能受雌激素影响。这为评估雌激素受体阻滞剂的治疗效用提供了理论依据；长期服用他莫昔芬是否能提高该肿瘤患者的生存率仍存在争议。本研究旨在评估他莫昔芬治疗肝细胞癌的疗效。

方法

120例不适用于手术、乙醇注射或经动脉栓塞的该肿瘤患者纳入一项安慰剂对照试验，随机分为他莫昔芬组（A组，n = 58），口服20 mg/天，或安慰剂组（B组，n = 62）。排除终末期疾病患者。

结果

两组在性别、年龄、肝功能（Child-Pugh评分，6.5±1.4对6.4±1.4）、基线体能状态和肿瘤分期方面相似。他莫昔芬无抗肿瘤作用，两组生存率无差异（1年和2年精算率：A组，51%和27%；B组，43%和29%；P = 0.75），即使根据基线状态对患者进行分层也是如此。此外，随访期间疾病进展概率（P = 0.46）和基线体能状态维持情况（P = 0.93）也无差异。