直肠癌新辅助放化疗后临床完全缓解等待观察策略可行性的Meta分析

目的:比较直肠癌新辅助放化疗后达到临床完全缓解（clinical complete response，cCR）采取等待观察策略和手术切除治疗策略在肿瘤控制及生存期方面的差异，以此阐述等待观察策略的可行性。方法:在国外数据库中检索关于直肠癌新辅助放化疗（nCRT）达到cCR关于等待观察策略和手术切除对比试验的相关文献，按照纳入和排除标准进行文献筛选和质量评估，使用STATA 12.0软件进行Meta分析，对比两组在局部复发、远处转移、肿瘤相关死亡、2年及5年无疾病进展生存期和总体生存期之间的差异。结果:本研究总共纳入9篇文献，Meta分析结果显示:等待观察组相比手术组有着较高的局部复发率（LR）（RR=5.05;95%CI:2.22~11.51;P<0.001)，但是两组在远处转移（RR=0.93;95%CI:0.51~1.68;P=0.805）、肿瘤相关死亡（RR=0.83;95%CI:0.37~1.87;P=0.658）、2年无疾病进展生存期（RR=0.97;95%CI:0.91~1.03;P=0.277）、2年总体生存期（RR=1.03;95%CI:0.97~1.10;P=0.346）、5年无疾病进展生存期（RR=0.95，95%CI:0.83~1.08;P=0.406）、5年总体生存期（RR=1.03;95%CI:0.95~1.11;P=0.534）并无统计学差异。结论:对于部分nCRT后达到cCR的患者采用等待观察策略是可行的，但需要制定严格的筛选标准以及规范的随访。

Feasibility of Watch and Wait treatment strategies for rectal cancer patients with clinical complete response after neoadjuvant chemoradiotherapy:A Meta-analysis

Objective:To compare the oncological outcomes between Watch and Wait with clinical complete response and surgery after neoadjuvant chemoradiotherapy via Meta-analysis.Methods:The clinical trials about Watch and Wait treatment strategies versus operation were comprehensively search on PubMed，Embase，Web of Science.Literature screening was carried out according to the established inclusion criteria and exclusion criteria and the qualities of each study were assessed using the Newcastle-Ottawa quality assessment scale.The main outcomes were local recurrence，distant metastasis，cancer-related death，2 and 5 years disease-free survival(DFS) and overall survival(OS) and analyzed by STATA 12.0 software.Results:Total 9 eligible trials were included to compare the oncologic outcomes of rectal cancer patients achieving a cCR through Watch and Wait treatment approach with the patients trough radical surgery.Meta-analysis showed that the local recurrence rate was higher in observation group than the pCR group(RR=5.05;95%CI:2.22~11.51;P﹤0.001)，but there were no significant difference about distant metastasis (RR=0.93;95%CI:0.51~1.68;P=0.805)，cancer-related death(RR=0.83;95%CI:0.37~1.87; P=0.658)，2-year DFS（RR=0.97;95%CI:0.91~1.03;P=0.277），2-year OS (RR=1.03;95%CI:0.97~1.10;P=0.346)；5-year DFS(RR=0.95;95%CI:0.83~1.08;P=0.406)，5-year OS(RR=1.03;95%CI:0.95~1.11;P=0.534).Conclusion:The Watch and Wait treatment strategies was feasible for the partial patients who achieved cCR after neoadjuvant chemoradiotherapy.But this treatment strategy required rigorous screening criteria，standardized follow-up.Additionally，the prospective randomized controlled trials were warranted to evaluate this treatment option.