局部晚期直肠癌全程新辅助治疗的系统评价

Systematic Review on Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

目的:系统评价全程新辅助治疗(TNT)用于局部晚期直肠癌的疗效及安全性,以期为局部晚期直肠癌的治疗决策提供新的思路及临床证据。方法:通过检索the Cochrane Library、PubMed、Embase以及中国知网、万方数据库,收集截至2022年7月所有对比TNT与标准治疗的随机对照研究。根据纳入及排除标准,筛选出符合要求的文献进行质量评估,提取相关的数据和资料,采用Stata 14.0软件进行Meta分析。结果:共选取10篇文献,纳入2980例患者,文献质量较好,无发表偏倚。Meta分析结果显示,与标准治疗组比较,TNT组患者具有较高的病理学完全缓解率(RR=1.73,95%CI=1.45~2.06),且TNT组患者的无病生存期(HR=0.81,95%CI=0.70~0.95)、总生存期(HR=0.78,95%CI=0.65~0.93)更长,差异均有统计学意义(P<0.05)。两组患者3—4级不良事件发生率(RR=1.27,95%CI=0.93~1.75)、手术并发症发生率(RR=1.00,95%CI=0.88~1.14)的差异无统计学意义(P>0.05)。结论:对比标准治疗,TNT模式可改善局部晚期直肠癌患者的病理学完全缓解率,延长其无病生存期和总生存期,且未增加3—4级不良事件及手术并发症。

OBJECTIVE:To systematically review the efficacy and safety of total neoadjuvant therapy(TNT)for locally advanced rectal cancer,so as to provide new thinking and clinical evidence for the treatment decision-making of locally advanced rectal cancer.METHODS:Randomized controlled trials on comparison between TNT and standard treatment for locally advanced rectal cancer were collected by retrieving the Cochrane Library,PubMed,Embase,CNKI,Wanfang Data up to Jul.2022.According to the inclusion and exclusion criteria,the eligible literature was screened for quality assessment,relevant data and information were extracted,and Meta-analysis was performed by using Stata 14.0 software.RESULTS:Totally 10 studies were selected,including 2980 patients,with good literature quality and no publication bias.Results of Meta-analysis indicated that compared with the standard treatment group,patients in the TNT group had a higher pathological complete remission rate(RR=1.73,95%CI=1.45-2.06),and patients in the TNT group had longer disease-free survival(HR=0.81,95%CI=0.70-0.95)and overall survival(HR=0.78,95%CI=0.65-0.93),all with statistically significant differences(P<0.05).The differences in the incidences of grade 3-4 adverse events(RR=1.27,95%CI=0.93-1.75)and surgical complications(RR=1.00,95%CI=0.88-1.14)between two groups were not statistically significant(P>0.05).CONCLUSIONS:Compared with standard treatment,the TNT model can improve pathological complete remission rate,prolong disease-free and overall survival in patients with locally advanced rectal cancer,without increasing grade 3-4 adverse events or surgical complications.