全程新辅助治疗与标准治疗对局部进展期直肠癌疗效的Meta分析

Meta-analysis of the efficacy of total neoadjuvant therapy versus standard treatment in locally advanced rectal cancer

目的对全程新辅助治疗(TNT)在局部进展期直肠癌治疗中的疗效进行Meta分析,以期对临床治疗决策提供参考依据。方法通过检索中国知网、万方数据、Cochrane Library、PubMed、Embase数据库,收集从2003年1月至2021年1月所有对比TNT与标准治疗(将新辅助同步放化疗/术前短程放疗+全直肠系膜切除术+术后辅助化疗模式统称为标准治疗)的文献,试验组为TNT,对照组为标准治疗。筛选出合格的文献进行质量评估,并提取相关的数据和资料,采用RevMan 5.4软件进行Meta分析。结果共纳入14篇文献3352例患者,包括试验组1688例,对照组1664例。与对照组相比,试验组病理完全缓解(pCR)率更高(OR=1.87,95%CI:1.56~2.25,P<0.001),R0切除率更高(OR=1.37,95%CI:1.07~1.76,P=0.01),无病生存期(DFS)(HR=0.85,95%CI:0.74~0.98,P=0.02)与总生存期(OS)(HR=0.73,95%CI:0.62~0.85,P<0.001)更优;两组肿瘤降期、3~4级不良事件、保肛率、总并发症发生率、吻合口漏和切口感染发生率比较,差异均无统计学意义。结论对于局部进展期直肠癌患者,TNT尽管与标准治疗相比未显著改善OS和DFS,但明显提高了肿瘤的pCR率和R0切除率,是安全可行的。

Objective A Meta-analysis is conducted on the efficacy of total neoadjuvant therapy(TNT)in the treatment of locally advanced rectal cancer,in order to provide reference for clinical treatment decision-making.Methods By searching CNKI,Wanfang Data,Cochrane Library,PubMed and Embase databases from January 2003 to January 2021,all literatures comparing TNT with standard treatment(neoadjuvant chemoradiotherapy/preoperative short-course radiotherapy+total mesorectum excision+postoperative adjuvant chemotherapy collectively referred to as standard treatment)were collected.The trial group was TNT,and the control group was standard treatment.Qualified literatures were selected and literature quality was evaluated,relevant data and materials were extracted for Meta-analysis with RevMan 5.4 software.Results A total of 3352 patients in 14 literatures were included.There were 1688 cases in the trial group and 1664 cases in the control group.Compared to the control group,the rate of pathological complete response(pCR)in the trial group was higher(OR=1.87,95%CI:1.56-2.25,P<0.001),R0 resection rate was higher(OR=1.37,95%CI:1.07-1.76,P=0.01),disease-free survival(DFS)(HR=0.85,95%CI:0.74-0.98;P=0.02)and overall survival(OS)(HR=0.73,95%CI:0.62-0.85;P<0.001)were better.There were no significant differences in tumor descending stage,grade 3-4 adverse events,anus preserving rate,overall complications of operation,anastomotic fistula and incision infection between the two groups.Conclusion For patients with locally advanced rectal cancer,although TNT can’t significantly improve OS and DFS,it significantly improved the pCR rate and R0 resection rate,which is safe and feasible.