【摘要】 目的:评价直肠癌患者新辅助放化疗(NCRT)后达到临床完全缓解(cCR)采取"等待观察"(W&S)策略的安全性。方法:检索多个国外数据库并收集比较直肠癌患者NCRT后达到cCR采用W&S策略与根治性手术(RS)的临床研究。按纳入标准筛选文献、提取资料并进行文献质量评价,采用Stata/SE12.0统计软件对局部复发(LR)、远处转移(DM)、肿瘤相关死亡(CRD)、无疾病进展生存期(DFS)和总体生存期(OS)等指标进行Meta分析。结果:总共纳入11篇文献,均为中-高质量文献;共计直肠癌患者847例,其中W&S组378例,RS组469例。Meta分析结果显示,W&S组LR(RR=6.20,95%CI=2.68～14.30,P=0.000),2年OS(RR=1.05,95%CI=1.01～1.10,P=0.029)及3年OS(RR=1.09,95%CI=1.03～1.15,P=0.004)方面明显优于RS组,而两组在DM,CRD,2、3、5年DFS及5年OS方面差异无统计学意义(均P>0.05)。结论:对于部分NCRT后达到cCR的直肠患者采用W&S策略是安全可行的,但需制定严格的筛选标准以及规范的随访体系。亟待未来的大样本、多中心、前瞻性随机对照研究对W&S策略加以验证。更多还原

【Abstract】 Objective: To evaluate the safety of applying the "Wait-and-See"(W&S) strategy in rectal cancer patients with clinical complete response(cCR) after neoadjuvant chemoradiotherapy(NCRT). Methods: The clinical studies comparing using W&S strategy and radical surgery(RS) in rectal cancer patients with cCR after NCRT were collected by searching several foreign databases. After screening for inclusion, data extraction and quality assessment, Meta-analysis was performed on the variables that included local recurrence(LR), distant metastasis(DM), cancer-related death(CRD), disease-free survival(DFS) and overall survival(OS) by using Stata/SE 12.0 software.Results: Eleven studies with moderate to high quality were included, involving 847 patients, with 378 cases in W&S group and 469 cases in RS group. The results of Meta-analysis showed that W&S group was superior to RS group in terms of LR(RR=6.20, 95% CI=2.68–14.30, P=0.000), 2-year OS(RR=1.05, 95% CI=1.01–1.10, P=0.029) and 3-year OS(RR=1.09, 95% CI=1.03–1.15, P=0.004), while no differences were noted with regard to DM, CRD, or 2-, 3-and 5-year DFS as well as 5-year OS between the two groups(all P>0.05). Conclusion: W&S strategy is safe and feasible for some patients who achieved cCR after NCRT, but this strategy requires rigorous screening criteria and standardized follow-up program. Meanwhile, large sample size and multicentric, prospective randomized controlled trials are urgently expected to verify this treatment approach.更多还原