Abstract：
BACKGROUND: A watch-and-wait (WW) strategy or surgery for low to intermediate rectal cancer that has reached clinical complete remission (cCR) after neoadjuvant chemotherapy (nCRT) or total neoadjuvant therapy (TNT) has been widely used in the clinic, but both treatment strategies are controversial.
OBJECTIVE: The aim of this study was to compare the oncologic outcomes of a watch-and-wait strategy or a surgical approach to treat rectal cancer in complete remission and to report the evidence-based clinical advantages of the two treatment strategies.
METHODS: Seven national and international databases were searched for clinical trials comparing the watch-and-wait strategy with surgical treatment for oncological outcomes in patients with rectal cancer in clinical complete remission.
RESULTS: In terms of oncological outcomes, there was no significant difference between the watch-and-wait strategy and surgical treatment in terms of overall survival (OS) (HR = 0.92, 95% CI (0.52, 1.64), P = 0.777), and subgroup analysis showed no significant difference in 5-year disease-free survival (5-year DFS) between WW and both local excision (LE) and radical surgery (RS) (HR = 1.76, 95% CI (0.97, 3.19), P = 0.279; HR = 1.98, 95% CI (0.95, 4.13), P = 0.164), in distant metastasis rate (RR = 1.12, 95% CI (0.73, 1.72), P = 0.593), mortality rate (RR = 1.62, 95% CI (0.93, 2.84), P = 0.09), and organ preservation rate (RR = 1.05, 95% CI (0.94, 1.17), P = 0.394) which were not statistically significant and on the outcome indicators of local recurrence rate (RR = 2.09, 95% CI (1.44, 3.03), P < 0.001) and stoma rate (RR = 0.35, 95% CI (0.20, 0.61), P < 0.001). There were significant differences between the WW group and the surgical treatment group.
CONCLUSIONS: There were no differences in OS, 5-year DFS, distant metastasis, and mortality between the WW strategy group and the surgical treatment group. The WW strategy did not increase the risk of local recurrence compared with local resection but may be at greater risk of local recurrence compared with radical surgery, and the WW group was significantly better than the surgical group in terms of stoma rate; the WW strategy was evidently superior in preserving organ integrity compared to radical excision. Consequently, for patients who exhibit a profound inclination towards organ preservation and the evasion of stoma formation in the scenario of clinically complete remission of rectal cancer, the WW strategy can be contemplated as a pragmatic alternative to surgical interventions. It is, however, paramount to emphasize that the deployment of such a strategy should be meticulously undertaken within the ambit of a multidisciplinary team\'s management and within specialized centers dedicated to rectal cancer management.
OBJECTIVE: The aim of this study was to compare the oncologic outcomes of a watch-and-wait strategy or a surgical approach to treat rectal cancer in complete remission and to report the evidence-based clinical advantages of the two treatment strategies.
METHODS: Seven national and international databases were searched for clinical trials comparing the watch-and-wait strategy with surgical treatment for oncological outcomes in patients with rectal cancer in clinical complete remission.
RESULTS: In terms of oncological outcomes, there was no significant difference between the watch-and-wait strategy and surgical treatment in terms of overall survival (OS) (HR = 0.92, 95% CI (0.52, 1.64), P = 0.777), and subgroup analysis showed no significant difference in 5-year disease-free survival (5-year DFS) between WW and both local excision (LE) and radical surgery (RS) (HR = 1.76, 95% CI (0.97, 3.19), P = 0.279; HR = 1.98, 95% CI (0.95, 4.13), P = 0.164), in distant metastasis rate (RR = 1.12, 95% CI (0.73, 1.72), P = 0.593), mortality rate (RR = 1.62, 95% CI (0.93, 2.84), P = 0.09), and organ preservation rate (RR = 1.05, 95% CI (0.94, 1.17), P = 0.394) which were not statistically significant and on the outcome indicators of local recurrence rate (RR = 2.09, 95% CI (1.44, 3.03), P < 0.001) and stoma rate (RR = 0.35, 95% CI (0.20, 0.61), P < 0.001). There were significant differences between the WW group and the surgical treatment group.
CONCLUSIONS: There were no differences in OS, 5-year DFS, distant metastasis, and mortality between the WW strategy group and the surgical treatment group. The WW strategy did not increase the risk of local recurrence compared with local resection but may be at greater risk of local recurrence compared with radical surgery, and the WW group was significantly better than the surgical group in terms of stoma rate; the WW strategy was evidently superior in preserving organ integrity compared to radical excision. Consequently, for patients who exhibit a profound inclination towards organ preservation and the evasion of stoma formation in the scenario of clinically complete remission of rectal cancer, the WW strategy can be contemplated as a pragmatic alternative to surgical interventions. It is, however, paramount to emphasize that the deployment of such a strategy should be meticulously undertaken within the ambit of a multidisciplinary team\'s management and within specialized centers dedicated to rectal cancer management.
摘要：
背景：对于在新辅助化疗（nCRT）或完全新辅助治疗（TNT）后已达到临床完全缓解（cCR）的中低位直肠癌，观察等待（WW）策略或手术已在临床上广泛使用，但这两种治疗策略都存在争议.
目的：本研究的目的是比较观察和等待策略或手术方法治疗完全缓解的直肠癌的肿瘤学结果，并报告两种治疗策略的循证临床优势。
方法：在7个国家和国际数据库中搜索临床试验，比较观察和等待策略与手术治疗对临床完全缓解的直肠癌患者肿瘤预后的影响。
结果：就肿瘤学结果而言，观察并等待策略与手术治疗在总生存期（OS）方面没有显着差异（HR=0.92，95％CI（0.52，1.64），P=0.777),亚组分析显示，WW与局部切除术（LE）和根治性手术（RS）之间的5年无病生存率（5年DFS）没有显着差异（HR=1.76，95％CI（0.97，3.19），P=0.279；HR=1.98，95%CI（0.95，4.13），P=0.164),远处转移率(RR=1.12，95%CI(0.73，1.72)，P=0.593),死亡率(RR=1.62，95%CI(0.93，2.84)，P=0.09),和器官保存率(RR=1.05，95%CI(0.94，1.17)，P=0.394),对局部复发率的结果指标(RR=2.09,95%CI(1.44,3.03),P<0.001)和造口率(RR=0.35，95%CI(0.20，0.61)，P<0.001)。WW组与手术医治组之间有明显性差别。
结论：操作系统没有差异，5年DFS,远处转移,WW策略组和手术治疗组之间的死亡率。与局部切除术相比，WW策略没有增加局部复发的风险，但与根治性手术相比，局部复发的风险可能更高。在造口率方面，WW组明显优于手术组；与根治性切除术相比，WW策略在保持器官完整性方面明显优于手术组。因此,对于在临床上完全缓解直肠癌的情况下表现出对器官保存和吻合口形成有深刻倾向的患者，可以考虑将WW策略作为外科干预的实用替代方案。是的,然而,最重要的是要强调，这种战略的部署应在多学科团队管理的范围内和致力于直肠癌管理的专业中心内精心进行。
目的：本研究的目的是比较观察和等待策略或手术方法治疗完全缓解的直肠癌的肿瘤学结果，并报告两种治疗策略的循证临床优势。
方法：在7个国家和国际数据库中搜索临床试验，比较观察和等待策略与手术治疗对临床完全缓解的直肠癌患者肿瘤预后的影响。
结果：就肿瘤学结果而言，观察并等待策略与手术治疗在总生存期（OS）方面没有显着差异（HR=0.92，95％CI（0.52，1.64），P=0.777),亚组分析显示，WW与局部切除术（LE）和根治性手术（RS）之间的5年无病生存率（5年DFS）没有显着差异（HR=1.76，95％CI（0.97，3.19），P=0.279；HR=1.98，95%CI（0.95，4.13），P=0.164),远处转移率(RR=1.12，95%CI(0.73，1.72)，P=0.593),死亡率(RR=1.62，95%CI(0.93，2.84)，P=0.09),和器官保存率(RR=1.05，95%CI(0.94，1.17)，P=0.394),对局部复发率的结果指标(RR=2.09,95%CI(1.44,3.03),P<0.001)和造口率(RR=0.35，95%CI(0.20，0.61)，P<0.001)。WW组与手术医治组之间有明显性差别。
结论：操作系统没有差异，5年DFS,远处转移,WW策略组和手术治疗组之间的死亡率。与局部切除术相比，WW策略没有增加局部复发的风险，但与根治性手术相比，局部复发的风险可能更高。在造口率方面，WW组明显优于手术组；与根治性切除术相比，WW策略在保持器官完整性方面明显优于手术组。因此,对于在临床上完全缓解直肠癌的情况下表现出对器官保存和吻合口形成有深刻倾向的患者，可以考虑将WW策略作为外科干预的实用替代方案。是的,然而,最重要的是要强调，这种战略的部署应在多学科团队管理的范围内和致力于直肠癌管理的专业中心内精心进行。
