Intervention Review

Taxane containing regimens for metastatic breast cancer

  1. Davina Ghersi1,*,
  2. Nicholas Wilcken2,
  3. John Simes3,
  4. Emma Donoghue4

Editorial Group: Cochrane Breast Cancer Group

Published Online: 20 APR 2005

Assessed as up-to-date: 11 MAR 2004

DOI: 10.1002/14651858.CD003366.pub2


How to Cite

Ghersi D, Wilcken N, Simes J, Donoghue E. Taxane containing regimens for metastatic breast cancer. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD003366. DOI: 10.1002/14651858.CD003366.pub2.

Author Information

  1. 1

    NHMRC Clinical Trials Centre, The University of Sydney, Systematic Reviews and Healthcare Assessment, Camperdown, NSW, Australia

  2. 2

    Westmead and Nepean Hospitals, Medical Oncology, Westmead, NSW, Australia

  3. 3

    The University of Sydney, NHMRC Clinical Trials Centre, Camperdown, NSW, Australia

  4. 4

    National Institute of Clinical Studies, Melbourne, Victoria, Australia

*Davina Ghersi, Systematic Reviews and Healthcare Assessment, NHMRC Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia. ghersid@who.int.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 APR 2005

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Abstract

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

Background

It is generally accepted that taxanes are among the most active chemotherapy agents in the management of metastatic breast cancer.

Objectives

To identify and review the randomised evidence comparing taxane containing chemotherapy regimens with regimens not containing a taxane in the management of women with metastatic breast cancer.

Search methods

The specialised register maintained by the Editorial Base of the Cochrane Breast Cancer Group was searched on 12 March 2004 using the codes for "advanced breast cancer", "chemotherapy". Details of the search strategy applied by the Group to create the register, and the procedure used to code references, are described in the Group's module on the Cochrane Library.

Selection criteria

Randomised trials comparing taxane-containing chemotherapy regimens with regimens not containing taxanes in women with metastatic breast cancer.

Data collection and analysis

Data were collected from published trials. Studies were assessed for eligibility and quality, and data were extracted, by two independent reviewers. Hazard ratios were derived for time-to-event outcomes where possible, and a fixed effect model was used for meta-analysis. Response rates were analysed as dichotomous variables. Toxicity and quality of life data were extracted where present.

Main results

Twenty one eligible trials were identified of which 12 have published time-to-event data and 16 have reported response data. The quality of randomisation was generally not described.

An estimated 2621 deaths in 3643 randomised women demonstrate a statistically significant difference in favour of taxane-containing regimens with a HR for overall survival of 0.93 (95% CI=0.86-1.00, p=0.05) and no statistically significant heterogeneity. If the analysis is restricted to trials of firstline chemotherapy the HR changes to 0.92 and is no longer statistically significant (95% CI 0.84-1.02, p=0.11). There was also a significant difference in favour of taxanes in relation to time to progression (overall HR 0.92, 95%CI 0.85-0.99, p=0.02) and overall response in assessable women (overall OR 1.34, 95%CI 1.18-1.52, p<0.00001) however there was strong statistical evidence of heterogeneity (P<0.00001), probably reflecting the varying efficacy of the comparator regimens used in the trials.

Authors' conclusions

When all trials are considered, taxane-containing regimens appear to improve overall survival, time to progression and overall response in women with metastatic breast cancer. The degree of heterogeneity encountered indicates that taxane-containing regimens are more effective than some, but not all non-taxane-containing regimens.

 

Plain language summary

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

Taxane containing regimens for metastatic breast cancer

Chemotherapy including taxane could improve survival and disease progression in women with advanced breast cancer, but more research is needed on which regimens help most. Advanced (metastatic) breast cancer is cancer that has spread beyond the breast. Treatment usually involves chemotherapy (anti-cancer drugs) to try to reduce the cancer. Drugs can be used alone or in combination. Paclitaxel and docitaxel are chemotherapy drugs known as taxanes. Taxanes can inhibit cancer cells from dividing and reproducing. Adverse effects can include nausea, vomiting and hair loss, as well as allergic reactions which can be reduced by premedication. The review found that chemotherapy including taxanes improved survival and decreased the progression of advanced breast cancer. Further trials are needed to determine which chemotherapy regimens are most effective.

 

摘要

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

背景

轉移乳癌之Taxane治療

一般認為,在治療轉移性乳癌的化學治療中,taxanes是最有效的藥物之一。

目標

為了搜尋及評估比較含Taxane之化學療法與未含Taxane之化學治療之療效。

搜尋策略

於2003年5月2日,使用「晚期乳癌」及「化學療法」字碼,再由考科藍乳癌組所持有的資料庫專業登記中搜尋。關於用於建置登記的檢索策略細節,及使用於編碼參考的流程,在考科藍圖書館的乳癌組的模件裡被描述。

選擇標準

比較含taxane的化學療法與不含taxane的化學療法,於治療轉移性乳癌婦女的隨機分派試驗。

資料收集與分析

資料,收集已發表的試驗,資料由兩位獨立的評論家選出;評價其研究的適用性和品質。可能的話,由時間至事件發生之存活分析,得出風險比率,並且固定效應模式用於統合分析,反應率以兩分的變項分析。如有的話,也分析毒性和生活品質資料。

主要結論

21個符合條件的試驗被引用,其中包括12個有發表時間對事件的資料,與16個有報告回應資料,一般由於並未說明隨機分派的細節,故無法評價其分派品質。 在3643個隨機分派的婦女中,估計有2621個死亡,顯示有利於有含taxane的療法,具統計學上明顯差異,整體存活的風險比率是0.93(百分之九十五的信賴區間介於0.86與1.00之間,p值等於0.05),異質性分析不具統計意義。如果分析僅限制於第一線化學療法的試驗,風險比率則改為0.92,而且不再具有統計學上地顯著(百分之九十五的信賴區間介於0.84與1.02之間,p值等於0.11)。另關於疾病進展時間(整體的勝算比是1.34,百分之九十五的信賴區間介於1.18與1.52之間,p值等於0.02),及在評估婦女的整體反應(整體的風險比率是0.92,百分之九十五的信賴區間介於0.85與0.99之間,p值小於0.00001),均有明顯差異利於taxanes;然而統計學上具有高度的試驗異質性,或許反映在不同試驗中,使用的比較療法不同療效。。

作者結論

當全部試驗被考慮納入時,對有轉移乳癌的婦女,包含taxane的療法似乎會改善整體存活,疾病時間進展和整體反應。遇到的試驗間的異質性高時,顯示出含taxane的療法比一些含非taxane的療法有效,但不是全部。

翻譯人

本摘要由中山醫學大學附設醫院吳信宏翻譯。

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

總結

在有晚期乳癌的婦女,包含taxane的化學療法能改進存活和疾病進展,但需要更多的研究在哪個療法最有幫助。 晚期(轉移)乳癌是已經擴散出乳房以外的癌症;治療通常涉及到化學療法(抗癌症的藥)來設法降低癌症;藥物可以被單獨或者結合在一起使用;Paclitaxel和docitaxel是被屬於taxanes類的化學療法藥物;Taxanes可抑制癌細胞分裂和再生;副作用能包括噁心,嘔吐和掉髮;可事先使用藥物治療來降低過敏反應。本回顧發現,包含taxanes的化學療法可改善存活,並且減少晚期乳癌的進展,然而需要更進一步的試驗來確定哪種化學療法是最有效的。