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可手术乳腺癌女性的术前化疗。

Preoperative chemotherapy for women with operable breast cancer.

作者信息

Mieog J S D, van der Hage J A, van de Velde C J H

机构信息

Leiden University Medical Center, Department of Surgery, Albinusdreef 2, Leiden, Netherlands.

出版信息

Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.

Abstract

BACKGROUND

Currently, preoperative chemotherapy is the standard of care in locally advanced breast cancer to achieve local tumour downsizing in order to make surgery possible. Since the early 1980s, the role of preoperative chemotherapy in early stage (or operable) breast cancer has been the subject of study. Potential advantages are early introduction of systemic therapy, determination of chemosensitivity, reduction of tumour volume and downstaging of surgical requirement. Concerns exist about local control after downsized surgery and the delay of local treatment in patients with tumours resistant to chemotherapy.

OBJECTIVES

To assess the effectiveness of preoperative chemotherapy in women with operable breast cancer when compared to postoperative chemotherapy.

SEARCH STRATEGY

The Specialised Register maintained by the Editorial Base of the Cochrane Breast Cancer Group was searched on 4th of August 2005.

SELECTION CRITERIA

Randomised trials comparing preoperative chemotherapy with postoperative in women with operable breast cancer.

DATA COLLECTION AND ANALYSIS

Studies were assessed for eligibility and quality, and data were extracted by two independent review authors. Hazard ratios were derived for time-to-event outcomes directly or indirectly using the methods described by Parmar. Relative risks were derived for dichotomous outcomes. Meta-analyses were performed using fixed effect model.

MAIN RESULTS

We identified 14 eligible studies which randomised a total of 5,500 women. Median follow-up ranged from 18 to 124 months. Eight studies described a satisfactory method of randomisation.Data, based on 1139 estimated deaths in 4620 women available for analysis, show equivalent overall survival rates with a HR of 0.98 (95% CI, 0.87 to 1.09; p, 0.67; no heterogeneity). Preoperative chemotherapy increases breast conservation rates, yet at the associated cost of increased loco regional recurrence rates. However, this rate was not increased as long as surgery remains part of the treatment even after complete tumour regression (HR, 1.12; 95% CI, 0.92 to 1.37; p, 0.25; no heterogeneity. Preoperative chemotherapy was associated with fewer adverse effects. Pathological complete response is associated with better survival than residual disease (HR, 0.48; 95% CI, 0.33 to 0.69; p, < 10-4).

AUTHORS' CONCLUSIONS: This review suggests safe application of preoperative chemotherapy in the treatment of women with early stage breast cancer in order to down-stage surgical requirement, to evaluate chemosensitivity and to facilitate translational research.

摘要

背景

目前,术前化疗是局部晚期乳腺癌的标准治疗方法,目的是使局部肿瘤缩小以便能够进行手术。自20世纪80年代初以来,术前化疗在早期(或可手术)乳腺癌中的作用一直是研究的课题。其潜在优势包括早期引入全身治疗、确定化疗敏感性、缩小肿瘤体积以及降低手术要求。对于肿瘤缩小后手术的局部控制以及对化疗耐药患者局部治疗的延迟存在担忧。

目的

评估可手术乳腺癌女性术前化疗与术后化疗相比的有效性。

检索策略

2005年8月4日检索了Cochrane乳腺癌组编辑基地维护的专业注册库。

选择标准

比较可手术乳腺癌女性术前化疗与术后化疗的随机试验。

数据收集与分析

评估研究的纳入资格和质量,由两名独立的综述作者提取数据。使用Parmar描述的方法直接或间接得出事件发生时间结局的风险比。对于二分结局得出相对风险。使用固定效应模型进行荟萃分析。

主要结果

我们确定了14项符合条件的研究,共纳入5500名女性。中位随访时间为18至124个月。8项研究描述了令人满意的随机方法。基于4620名可分析女性中估计的1139例死亡数据,显示总体生存率相当,风险比为0.98(95%可信区间,0.87至1.09;p = 0.67;无异质性)。术前化疗提高了保乳率,但代价是局部区域复发率增加。然而,只要手术仍然是治疗的一部分,即使在肿瘤完全消退后,该复发率也不会增加(风险比,1.12;95%可信区间,0.92至1.37;p = 0.25;无异质性)。术前化疗的不良反应较少。病理完全缓解与比残留疾病更好的生存率相关(风险比,0.48;95%可信区间,0.33至0.69;p < 10⁻⁴)。

作者结论

本综述表明术前化疗可安全应用于早期乳腺癌女性的治疗,以降低手术要求、评估化疗敏感性并促进转化研究。

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