Intervention Review

Tamoxifen for hepatocellular carcinoma

  1. Anna K Nowak2,
  2. Michael Findlay3,
  3. Gordana Culjak4,
  4. Martin R Stockler1,*

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 19 JUL 2004

Assessed as up-to-date: 23 MAY 2004

DOI: 10.1002/14651858.CD001024.pub2


How to Cite

Nowak AK, Findlay M, Culjak G, Stockler MR. Tamoxifen for hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD001024. DOI: 10.1002/14651858.CD001024.pub2.

Author Information

  1. 1

    University of Sydney, NHMRC Clinical Trials Centre and Sydney Cancer Centre, Camperdown, NSW, Australia

  2. 2

    Sir Charles Gardiner Hospital and University of Western Australia, Department of Medical Oncology, Perth, WA, Australia

  3. 3

    Wellington Hospital, Medical Oncology, Wellington South, New Zealand

  4. 4

    Faculty of Information Technology, Department of Information Systemes, Sydney, NSW, Australia

*Martin R Stockler, NHMRC Clinical Trials Centre and Sydney Cancer Centre, University of Sydney, GH6 RPAH, Missenden Road, Camperdown, NSW, 2050, Australia. stockler@med.usyd.edu.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 JUL 2004

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Hepatocellular carcinoma (primary liver cancer) is the third commonest cause of cancer mortality world-wide. Survival is poor for patients with advanced disease. Trials of tamoxifen for hepatocellular carcinoma have conflicting results.

Objectives

To conduct a systematic review of the literature to assess the effect of tamoxifen on overall survival, quality-of-life, tumour response, and treatment toxicity in people with advanced hepatocellular carcinoma.

Search methods

We identified trials from The Cochrane Hepato-Biliary Group Controlled Trials Register (January 2004), The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 3, 2003), and MEDLINE database (1966 to November 2003). We searched bibliographies of review articles and identified trials, and hand-searched abstracts from relevant other meetings.

Selection criteria

All randomised clinical trials of treatment with tamoxifen compared to a control treatment without tamoxifen in people with hepatocellular carcinoma, including trials of tamoxifen versus placebo, tamoxifen versus best supportive care, and tamoxifen plus other treatment versus the same other treatment alone.

Data collection and analysis

Three independent reviewers selected studies for inclusion, rated them for methodologic quality components (generation of allocation sequence; allocation concealment; blinding; and follow-up), and extracted data on the specified outcomes. Hazard ratios were derived for overall survival where possible. Meta-analysis was performed using a fixed-effect model.

Main results

Ten randomised trials randomising 1709 patients were included. Tamoxifen versus placebo/no intervention had no significant effect on overall survival (hazard ratio 1.05; 95% CI 0.94 to 1.16; P = 0.4). This comparison showed no statistical heterogeneity (P = 0.2 and I2 = 25.9%). Subgroup analysis showed that tamoxifen tended to increase mortality in trials with three adequate/three methodological components (hazard ratio 1.15; 95% CI 0.99 to 1.34; P = 0.06), showed no significant effect in trials with two adequate/three methodological components (hazard ratio 1.00; 95% CI 0.84 to 1.18; P = 0.98), and tended to reduce mortality in trials with one or less adequate/three methodological components (hazard ratio 0.82; 95% CI 0.60 to 1.12; P = 0.2), although this may have been confounded by the use of higher doses of tamoxifen in the better quality trials. Tamoxifen was associated with adverse effects. One trial measured patient quality of life, but the results were not reported in detail.

Authors' conclusions

These data do not support the use of tamoxifen for patients with hepatocellular carcinoma. Further research on the effects of tamoxifen in hepatocellular carcinoma does not seem warranted.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Tamoxifen does not improve survival in patients with hepatocellular carcinoma

Hepatocellular carcinoma (primary liver cancer) is a common cause of death from cancer world-wide. It is usually fatal in patients who cannot be treated with surgery or other local treatments. Tamoxifen is an anti-oestrogen drug, which has been tested in advanced hepatocellular carcinoma. The reviewers identified 10 trials assessing the effect of tamoxifen on survival, quality of life, tumour size, and treatment side effects in advanced hepatocellular carcinoma. Tamoxifen had no significant effect on survival or tumour size. Tamoxifen did not improve quality of life.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

以Tamoxifen治療肝細胞癌

肝細胞癌 (原發性肝癌)是世界上患癌症死亡的第3大常見原因。末期患者的存活率非常低。Tamoxifen治療肝細胞癌的試驗一直存在有爭議性的結果。

目標

對文獻展開系統性的文獻回顧,評估Tamoxifen在總存活率, 生活品質, 腫瘤反應和治療毒性等方面對治療末期肝細胞癌病人的療效。

搜尋策略

透過搜尋The Cochrane HepatoBiliary Group Controlled Trials Register (2004年1月), The Cochrane Library的(2003年第3期) The Cochrane Central Register of Controlled Trials、 MEDLINE 資料庫(1966年 2003年9月),我們搜尋相關試驗。我們搜尋文獻回顧文章和已找出的試驗的目錄,手動搜尋其他相關學術會議的摘要。

選擇標準

所有以Tamoxifen治療對照無Tamoxifen治療來治療肝細胞癌的隨機臨床控制試驗,包括Tamoxifen對照安慰劑、Tamoxifen對照最佳的支持性照護療法、Tamoxifen加上其它療法對照只單用相同的其它療法。

資料收集與分析

三位回顧作者獨立地選擇收納研究,依照研究方法品質組成來劃分等級 (分配順序的生成、分配方案的隱藏、盲法、後續追蹤),並摘錄特定的結果數據。如果可以的話,計算Hazard ratios以評估整體存活利益。使用固定效果模式來實施統合分析。

主要結論

共包括10個隨機試驗,包括1709 位病人。和安慰劑/無干預法比較,Tamoxifen對總存活率 (hazard ratio 1.05; 95% CI 0.94 1.16; P = 0.4)沒有明顯作用。本次比較顯示不存在統計異質性(P = 0.2,I2 = 25.9%)。亞組分析顯示,有三種適當/三種方法學成分的試驗中,Tamoxifen傾向於增加死亡率(hazard ratio 1.15; 95% CI 0.99 – 1.34; P = 0.06), 在兩種適當/三種方法學成分的試驗中,顯示對死亡率沒有顯著作用(hazard ratio 1.00; 95% CI 0.84 1.18; P = 0.98),在一或少於一種適當/三種方法學成分的試驗中,顯示可以降低死亡率(hazard ratio 0.82; 95% CI 0.60 1.12; P = 0.2),雖然這種結果在品質較高的試驗中會被使用高劑量Tamoxifen干擾。Tamoxifen和不良反應相關。 一項試驗檢測了病人的生活品質,但是沒有詳細呈現。

作者結論

上述資料不能支持以Tamoxifen治療肝細胞癌的病人。對Tamoxifen治療肝細胞癌的療效進行深入研究似乎並無必要。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Tamoxifen不能改善肝細胞癌病人的存活率。肝細胞癌 (原發性肝癌) 是一種世界上因為癌症死亡的常見病因。對於無法接受手術治療或其他局部療法的病人通常會導致死亡。Tamoxifen是一種抗女性激素的藥物,在末期肝細胞癌中接受了檢驗。回顧作者共找出10個試驗,從存活率、生活品質、腫瘤大小和治療副作用等方面評估Tamoxifen對末期肝細胞癌的作用。 Tamoxifen對於存活率或腫瘤大小沒有顯著療效。Tamoxifen也不能改善生活品質。