Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China.
Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Deputy No. 2, West Weiyang Road, Xianyang City, Shaanxi Province, 712000, China.
Int J Colorectal Dis. 2023 Oct 3;38(1):246. doi: 10.1007/s00384-023-04534-2.
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.
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.
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.
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.
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.
新辅助化疗(nCRT)或全直肠系膜新辅助治疗(TNT)后达到临床完全缓解(cCR)的低至中危直肠肿瘤,临床广泛采用观察等待(WW)策略或手术治疗,但两种治疗策略均存在争议。
本研究旨在比较观察等待策略与手术治疗完全缓解直肠肿瘤的肿瘤学结果,并报告两种治疗策略的循证临床优势。
检索 7 个国家和国际数据库,比较完全缓解的直肠癌患者观察等待策略与手术治疗的肿瘤学结果的临床试验。
在肿瘤学结果方面,观察等待策略与手术治疗在总生存(OS)方面无显著差异(HR=0.92,95%CI(0.52,1.64),P=0.777),亚组分析显示 WW 组与局部切除(LE)和根治性手术(RS)组 5 年无病生存率(5-year DFS)无显著差异(HR=1.76,95%CI(0.97,3.19),P=0.079;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)和器官保留率(RR=1.05,95%CI(0.94,1.17),P=0.394)无统计学意义,局部复发率(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)差异有统计学意义。WW 组与手术治疗组之间存在显著差异。
WW 策略组与手术治疗组在 OS、5 年 DFS、远处转移和死亡率方面无差异。与局部切除相比,WW 策略并未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,WW 组在造口率方面明显优于手术组;WW 策略在保护器官完整性方面明显优于根治性切除。因此,对于在直肠癌临床完全缓解的情况下表现出强烈的器官保留倾向和避免造口形成的患者,可以考虑 WW 策略作为手术干预的一种替代方案。然而,必须强调的是,在多学科团队管理和专门的直肠肿瘤管理中心内,必须谨慎地开展这种策略的应用。