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紫杉烷类用于早期乳腺癌的辅助治疗。

Taxanes for adjuvant treatment of early breast cancer.

作者信息

Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak A K

出版信息

Cochrane Database Syst Rev. 2007 Oct 17(4):CD004421. doi: 10.1002/14651858.CD004421.pub2.

Abstract

BACKGROUND

Adjuvant chemotherapy improves survival in pre- and post-menopausal women with early breast cancer. Taxanes are highly active chemotherapy agents in metastatic breast cancer. Their role in early breast cancer was examined in this review.

OBJECTIVES

To review the randomised evidence comparing taxane containing chemotherapy regimens with non-taxane containing chemotherapy regimens as adjuvant treatment of pre- or post-menopausal women with early breast cancer.

SEARCH STRATEGY

The Cochrane Breast Cancer Group Specialised Register was searched on 9th January 2007 using the codes for 'early breast cancer' and keywords for taxanes. Details of the search strategy used to create the register are described in the Group's module in The Cochrane Library. The reference lists of other related literature reviews and articles were also searched.

SELECTION CRITERIA

Randomised trials comparing taxane containing regimens with non-taxane containing regimens in women with operable breast cancer. Women receiving neoadjuvant chemotherapy were excluded.

DATA COLLECTION AND ANALYSIS

Data were collected from published trials and abstracts. Studies were assessed for eligibility and quality and the data extracted independently by two review authors. Hazard ratios (HR) were derived for time-to-event outcomes, and meta-analysis was performed using a fixed-effect model. The primary outcome measure was overall survival (OS); disease-free survival (DFS) was a secondary outcome measure. Toxicity and quality of life data were extracted when reported.

MAIN RESULTS

We identified 20 studies, 12 of these (7 full publications, 5 abstracts) had sufficient data published for inclusion (11 for OS and 11 for DFS) in the review. The weighted average median follow up was 60.4 months. All studies fulfilled quality criteria either adequately or well. Amongst 18,304 women with 2483 deaths, the HR for OS was 0.81 (95% CI 0.75 to 0.88, P < 0.00001) favouring taxane containing regimens. Amongst 19,943 women with 4800 events, the HR for DFS was 0.81 (95% CI 0.77 to 0.86, P < 0.00001) favouring taxane containing regimens. There was no statistical heterogeneity for either OS or DFS.

AUTHORS' CONCLUSIONS: This meta-analysis of studies supports the use of taxane containing adjuvant chemotherapy regimens with improvement of overall survival and disease-free survival for women with operable early breast cancer. The review did not identify a subgroup of patients where taxane containing treatment may have been more or less effective. Dosage and scheduling of the taxane drug is not clearly defined and we await results of the next generation of studies to determine the optimal use of taxanes in early breast cancer.

摘要

背景

辅助化疗可提高绝经前和绝经后早期乳腺癌女性的生存率。紫杉烷类是转移性乳腺癌中活性很高的化疗药物。本综述探讨了它们在早期乳腺癌中的作用。

目的

综述比较含紫杉烷类化疗方案与不含紫杉烷类化疗方案作为绝经前或绝经后早期乳腺癌女性辅助治疗的随机对照证据。

检索策略

2007年1月9日,使用“早期乳腺癌”代码和紫杉烷类关键词检索了Cochrane乳腺癌小组专业注册库。用于创建该注册库的检索策略详情在Cochrane图书馆小组模块中有描述。还检索了其他相关文献综述和文章的参考文献列表。

入选标准

比较含紫杉烷类方案与不含紫杉烷类方案治疗可手术乳腺癌女性的随机试验。接受新辅助化疗的女性被排除。

数据收集与分析

从已发表的试验和摘要中收集数据。评估研究的纳入资格和质量,由两位综述作者独立提取数据。计算事件发生时间结局的风险比(HR),并使用固定效应模型进行荟萃分析。主要结局指标为总生存期(OS);无病生存期(DFS)为次要结局指标。如有报道,提取毒性和生活质量数据。

主要结果

我们确定了20项研究,其中12项(7篇全文发表,5篇摘要)有足够的数据发表可供纳入本综述(11项用于OS分析,11项用于DFS分析)。加权平均中位随访时间为60.4个月。所有研究均充分或较好地满足质量标准。在18304名女性中,有2483人死亡,含紫杉烷类方案组的OS的HR为0.81(95%CI 0.75至0.88,P<0.00001)。在19943名女性中,有4800例事件发生,含紫杉烷类方案组的DFS的HR为0.81(95%CI 0.77至0.86,P<0.00001)。OS和DFS均无统计学异质性。

作者结论

本研究的荟萃分析支持使用含紫杉烷类辅助化疗方案来提高可手术早期乳腺癌女性的总生存期和无病生存期。该综述未发现含紫杉烷类治疗可能更有效或效果较差的患者亚组。紫杉烷类药物的剂量和给药方案尚未明确界定,我们期待下一代研究的结果来确定紫杉烷类在早期乳腺癌中的最佳应用。

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