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新辅助治疗及手术后直肠癌辅助化疗的系统评价与荟萃分析

A systematic review and meta-analysis of adjuvant chemotherapy after neoadjuvant treatment and surgery for rectal cancer.

作者信息

Petrelli Fausto, Coinu Andrea, Lonati Veronica, Barni Sandro

机构信息

Medical Oncology Unit, Oncology Department, Azienda Ospedaliera Treviglio, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy,

出版信息

Int J Colorectal Dis. 2015 Apr;30(4):447-57. doi: 10.1007/s00384-014-2082-9. Epub 2014 Nov 30.

Abstract

BACKGROUND

Current guidelines support the use of adjuvant chemotherapy (CT) following neoadjuvant chemoradiotherapy (CTRT) and surgery to treat rectal cancer, although clinical trials have provided little evidence that it is effective. We performed a systematic review of published studies to assess whether adjuvant CT improves outcome after neoadjuvant therapy and radical surgery in cases of rectal cancer.

MATERIALS AND METHODS

We conducted an electronic database search for randomized and nonrandomized studies in PubMed, EMBASE, Web of Science, Scopus and the Cochrane Register of Controlled Trials. We then carried out a meta-analysis by using the fixed- or random-effects models. The primary endpoint was 5-year overall survival (OS) reported as odds ratios (ORs) and 95% confidence intervals (CIs).

RESULTS

Two randomized controlled trials (RCTs), one pooled analysis of five RCTs and 10 retrospective studies that included a total of 5,457 patients matched our selection criteria. Meta-analysis showed that for rectal cancer patients treated with surgery and neoadjuvant CTRT, adjuvant CT improves 5-year OS (OR, 0.64; 95% CI, 0.46-0.88; p = 0.006) and 5-year disease-free survival (DFS) (OR, 0.71; 95% CI, 0.6-0.83; p < 0.0001). The 5-year OS benefit was significantly larger in downstaged patients and in retrospective series. A better DFS was instead noted in all studies due to a reduced risk of local relapse.

CONCLUSIONS

Amongst rectal cancer patients treated with neoadjuvant therapy and surgery, adjuvant CT seems to improve the 5-year DFS and OS rates and may be discussed with patients. However, the benefit derives mainly from retrospective evidence.

摘要

背景

目前的指南支持在新辅助放化疗(CTRT)及手术治疗直肠癌后使用辅助化疗(CT),尽管临床试验几乎没有提供其有效的证据。我们对已发表的研究进行了系统评价,以评估辅助CT是否能改善直肠癌新辅助治疗及根治性手术后的预后。

材料与方法

我们在PubMed、EMBASE、科学网、Scopus和Cochrane对照试验注册库中对随机和非随机研究进行了电子数据库检索。然后我们使用固定效应或随机效应模型进行荟萃分析。主要终点是5年总生存率(OS),以比值比(OR)和95%置信区间(CI)报告。

结果

两项随机对照试验(RCT)、一项对五项RCT的汇总分析以及10项回顾性研究,共纳入5457例患者,符合我们的纳入标准。荟萃分析显示,对于接受手术及新辅助CTRT治疗的直肠癌患者,辅助CT可提高5年OS(OR,0.64;95%CI,0.46 - 0.88;p = 0.006)和5年无病生存率(DFS)(OR,0.71;95%CI,0.6 - 0.83;p < 0.0001)。在降期患者和回顾性系列研究中,5年OS获益显著更大。相反,由于局部复发风险降低,在所有研究中均观察到更好的DFS。

结论

在接受新辅助治疗和手术的直肠癌患者中,辅助CT似乎可提高5年DFS和OS率,可与患者讨论。然而,这种获益主要来自回顾性证据。

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