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中华普外科手术学杂志(电子版)

中华普外科手术学杂志(电子版) ›› 2018, Vol. 12 ›› Issue (06) : 485 -489. doi: 10.3877/cma.j.issn.1674-3946.2018.06.012

所属专题： 文献；

论著

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
孙家琛1, 陈俊榕2,†(), 赖明广3   
  1. 1. 510655　广州，中山大学附属第六医院消化内镜科
    2. 510655　广州，中山大学附属第六医院消化内科
    3. 深圳，暨南大学第二临床医学院消化内科
  • 收稿日期:2018-07-26 出版日期:2018-12-26
  • 通信作者: 陈俊榕

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

jiachen Sun1, junrong Chen2,†(), Ming Guang Lai3   

  1. 1. Department of digestive endoscopy, the sixth affiliated hospital of sun Yat-sen university, Guangdong 510655, China
    2. Department of gastroenterology, the sixth affiliated hospital of sun Yat-sen university, Guangdong 510655, China
    3. Department of gastroenterology, the second clinical medical college, Jinan university, Guangdong 510655, China
  • Received:2018-07-26 Published:2018-12-26
  • Corresponding author: junrong Chen
  • About author:
    Corresponding author: Chen Junrong, Email:
  • Supported by:
    National Natural Science Foundation(NO.81472275)
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引用本文：

孙家琛, 陈俊榕, 赖明广. 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[J/OL]. 中华普外科手术学杂志(电子版), 2018, 12(06): 485-489.

jiachen Sun, junrong Chen, Ming Guang Lai. Meta-analysis of randomized controlled trials of neoadjuvant radiotherapy and chemoradiotherapy combined with TME surgery for locally advanced rectal cancer[J/OL]. Chinese Journal of Operative Procedures of General Surgery(Electronic Edition), 2018, 12(06): 485-489.

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PubMed、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。

关键词: 直肠肿瘤, 肠系膜, 放射疗法，辅助, 化学疗法，辅助, Meta分析
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 choose a suitable neoadjuvant treatment plan according to the patient’s tolerance in clinical application.

Key words: Rectal Neoplasms, Mesentery, Radiotherapy, Adjuvant, Chemotherapy, Adjuvant, Meta-Analysis
表1 纳入研究进展期直肠癌新辅助放疗与化放疗联合TME随机对照试验的文献基本资料
研究项目 国家 时期 处理 病例数 平均年龄 治疗方案 生物效应剂量 间隔时间 随访时间 Jadad评分
Gerard 2006[5] France 1993～2003 RT 367 63 45Gy/25fr 37.5Gy 3～10周 81月 3
? ? ? CRT 375 64 45Gy/25fr加5－FU＋LV 37.5Gy ? ? ?
Bosset 2006[4] France 1993～2003 RT 505 63 45Gy/25fr 37.5Gy 5周 5.4年 3
? ? ? CRT 506 63 45Gy/25fr加5－FU＋LV 37.5Gy ? ? ?
Bujko 2006[6] Poland 1999～2002 RT 155 ? 25Gy/5fr 38.7Gy 7 d 48月 3
? ? ? CRT 157 ? 50.4Gy/28fr加5－FU＋LV 40.9Gy 4～6周 ? ?
Pouanet 2006[7] France 2001～2005 RT 106 ? 45Gy加18Gy － － 22月 2
? ? ? CRT 101 ? 45Gy加5－FU － ? ? ?
BRCT[8] Germany 2004－ RT ? ? 25Gy/5fr 38.7Gy ? ? ?
? ? ? CRT ? ? 50.4Gy/28fr加5－FU 40.9Gy ? ? ?
TROG/AGITG[9] Australia RT ? ? ? 25Gy/5fr 38.7Gy ? ? ?
? ? ? CRT ? ? 50.4Gy/28fr加5－FU 40.9Gy ? ? ?
CPPKU[10] Lithuania RT ? ? ? 25Gy/5fr 38.7Gy ? ? ?
? ? ? CRT ? ? 50Gy/28fr加5－FU 40.2Gy ? ? ?
图1 文献筛选流程图及结果
图2 新辅助放疗组与新辅助化放疗组pCR的比较
图3 新辅助放疗组和新辅助化放疗组保肛率的比较
图4 新辅助放疗组和新辅助化放疗组R0期根治性切除率的比较
图5 新辅助放疗组与新辅助化放疗组5年局部复发率的比较
图6 新辅助放疗组与新辅助化放疗组5年远处转移率的比较
图7 新辅助放疗组与新辅助化放疗组5年总生存率的比较
图8 新辅助放疗组与新辅助化放疗组5年无病生存率的比较
图9 新辅助放疗组与新辅助化放疗组30d内死亡率的比较
图10 新辅助放疗组与新辅助化放疗组严重急慢性不良反应的比较
图11 新辅助放疗组与新辅助化放疗组术后并发症发病率的比较
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