进展期直肠癌新辅助放疗与化放疗联合TME随机对照试验的Meta分析

Meta-analysis of randomized controlled trials of neoadjuvant radiotherapy and chemoradiotherapy combined with TME surgery for locally advanced rectal cancer

目的评价新辅助放疗组与新辅助化放疗组联合全直肠系膜切除术(TME)治疗局部进展期直肠癌的安全性与疗效。方法检索2002年至2017年Pub Med、OVID、Cochrane图书馆、中国生物医学文献数据库(CBM)、中国知网全文数据库(CNKI)、万方数据库关于新辅助治疗联合TME手术治疗局部进展期直肠癌的文献,对符合纳入标准的文献进行质量评价,采用Revman5. 0软件检验异质性,进行meta分析。结果共4个随机对照试验共2 272例直肠癌患者纳入研究,新辅助放疗组1 133例患者,新辅助化放疗组1 139例患者。与新辅助化放疗组相比,单纯新辅助放疗组的完全病理缓解率更低(OR=0. 32,95%CI:0. 22～0. 44,P <0. 05),5年局部复发率更高(OR=2. 13,95%CI:1. 62～2. 79,P <0. 05),严重不良反应更少(OR=0. 38,95%CI:0. 17～0. 82,P=0. 01),差异有统计学意义。但保肛率、术后并发症发病率、5年无病生存率和总生存率差异无统计学意义。结论新辅助化放疗总体上优于单纯新辅助放疗治疗进展期直肠癌,但临床应用中仍需要根据患者的耐受情况选择合适的新辅助治疗方案。

Objective to evaluate the safety and efficacy of neoadjuvant radiotherapy and neoadjuvant chemoradiotherapy combined with total mesorectal excision （TME） in the treatment for locally advanced rectal cancer. Methods Database including PubMed, ovid, Cochrane library, Chinese biomedical literature database （ CBM ）, CNKI and Wanfang were retrieved from 2002 to 2017 on neoadjuvant therapy combined with TME surgery for locally advanced rectal cancer.The quality of the literatures that met the inclusion criteria were evaluated. Revman 5.0 software was used to examine the heterogeneity and meta-analysis was performed. Results A total of 4 randomized controlled trials involving 2272 rectal cancer patients were included in the study. There were 1133 patients in the neoadjuvant chemoradiotherapy group and 1139 patients in the neoadjuvant radiotherapy group. Compared with the neoadjuvant chemoradiotherapy y group, the complete pathological remission rate was lower in neoadjuvant radiotherapy group （ OR=0.32, 95 % CI： 0.22-0.44, P 〈0.05 ）, with higher 5-years local recurrence rate （ OR=2.13, 95 % CI： 1.62-2.79, P 〈0.05 ）, however with less serious adverse reactions （ OR=0.38, 95 % CI： 0.17-0.82, P=0.01 ）, with statistically significant difference. However, there was no significant difference of anus-preserving rate, postoperative complication rate, 5-years disease-free survival rate and overall survival rate. Conclusion Neoadjuvant chemoradiotherapy is generally superior to neoadjuvant radiotherapy alone in the treatment for advanced rectal cancer, but it is still necessary to choosea suitable neoadjuvant treatment plan according to the patient’s tolerance in clinical application.