右侧结肠癌淋巴结切除程度的长期生存率：一项随机对照试验（RELARC试验）的五年随访结果。

IF 6.4 1区医学 Q1 SURGERY

Annals of surgery Pub Date : 2025-09-12 DOI:10.1097/sla.0000000000006941

Kexuan Li,Hongbo Li,Aiwen Wu,Lu Zang,Guannan Zhang,Lai Xu,Junyang Lu,Jiadi Xing,Bo Feng,Yueming Sun,Xiaohui Du,Pan Chi,Jianmin Xu,Ziqiang Wang,Yuelun Zhang,Zhongtao Zhang,Minhua Zheng,Xiangqian Su,Yi Xiao,

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In patients with lymph node metastasis, complete mesocolic excision (CME) showed potentially favorable results.\r\n\r\nMETHODS\r\nThe parallel, open label, randomized controlled trial was conducted between January, 2016 to December, 2019 in 17 hospitals in China. Of a total of 1072 eligible patients enrolled, 995 patients were included in the modified intention-to-treat analysis. In the present study, the primary outcome was 5-year OS and the secondary outcome was 5-year CSS. The trial is registered with ClinicalTrials.gov (Identifier: NCT02619942).\r\n\r\nRESULTS\r\n995 patients were included in the final analysis. There was no significant difference between the 5-year OS (HR: 0.74, 95%CI: 0.51-1.07, P=0.105) or CSS (HR: 0.72, 95%CI: 0.49-1.06, P=0.091) in the CME and D2 groups. 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引用次数: 0

摘要

目的比较右侧结肠癌患者行CME与D2手术5年随访后的总生存期（OS）和肿瘤特异性生存期（CSS），并评估不同亚组CME治疗效果的异质性。背景资料：为期3年的腹腔镜结肠癌右结肠切除术根治性淋巴结切除术（RELARC）试验结果显示，右侧结肠癌患者应进行标准D2清扫。在淋巴结转移的患者中，完全肠系膜切除术（CME）显示出潜在的有利结果。方法2016年1月至2019年12月，在中国17家医院进行平行、开放标签、随机对照试验。在纳入的1072名符合条件的患者中，995名患者被纳入改良意向治疗分析。在本研究中，主要终点为5年OS，次要终点为5年CSS。该试验已在ClinicalTrials.gov注册（标识符：NCT02619942）。结果995例患者纳入最终分析。CME组和D2组的5年OS （HR: 0.74, 95%CI: 0.51-1.07， P=0.105）和CSS （HR: 0.72, 95%CI: 0.49-1.06， P=0.091）差异无统计学意义。CME似乎改善了III期疾病患者的5年预后（OS: HR: 0.58, 95% CI: 0.37-0.93， P=0.023; CSS: HR: 0.59, 95% CI: 0.37-0.94， P=0.028），特别是pN2患者（OS: HR: 0.25, 95% CI: 0.11-0.57， P=0.001; CSS: HR: 0.25, 95% CI: 0.11-0.57， P=0.001），其中发现了统计学上显著的相互作用。淋巴血管侵犯患者也表现出良好的预后，且有显著的交互作用（OS: HR: 0.34, 95% CI: 0.17-0.70，交互作用P=0.009; CSS: HR: 0.32, 95% CI: 0.15-0.67，交互作用P=0.008）。结论：在5年随访中，标准D2夹层提供了与CME相当的肿瘤预后。然而，CME似乎改善了III期患者的5年预后，特别是那些pN2状态的患者，并且可能给LVI患者带来益处。

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Long-Term Survival on Extent of Lymphadenectomy for Right-Sided Colon Cancer: Five-Year Follow-up Results of a Randomized Controlled Trial (RELARC Trial).

OBJECTIVE To compare the overall survival (OS) and cancer-specific survival (CSS) of right-sided colon cancer patients undergoing CME versus D2 surgery after 5 years of follow-up, and to assess the heterogeneity of treatment effectiveness of CME between different subgroups. SUMMARY BACKGROUND DATA The 3-year result of the Radical Extent of lymphadenectomy of Laparoscopic Right Colectomy for colon cancer (RELARC) trial showed that standard D2 dissection should be performed in right-sided colon cancer patients. In patients with lymph node metastasis, complete mesocolic excision (CME) showed potentially favorable results. METHODS The parallel, open label, randomized controlled trial was conducted between January, 2016 to December, 2019 in 17 hospitals in China. Of a total of 1072 eligible patients enrolled, 995 patients were included in the modified intention-to-treat analysis. In the present study, the primary outcome was 5-year OS and the secondary outcome was 5-year CSS. The trial is registered with ClinicalTrials.gov (Identifier: NCT02619942). RESULTS 995 patients were included in the final analysis. There was no significant difference between the 5-year OS (HR: 0.74, 95%CI: 0.51-1.07, P=0.105) or CSS (HR: 0.72, 95%CI: 0.49-1.06, P=0.091) in the CME and D2 groups. CME appears to improve 5-year outcomes in patients with stage III disease (OS: HR: 0.58, 95% CI: 0.37-0.93, P=0.023; CSS: HR: 0.59, 95% CI: 0.37-0.94, P=0.028), particularly in those with pN2 (OS: HR: 0.25, 95% CI: 0.11-0.57, P=0.001; CSS: HR: 0.25, 95% CI: 0.11-0.57, P=0.001), where a statistically significant interaction was identified. Patients with lymphovascular invasion also demonstrated favorable outcomes with CME with significant interaction effect (OS: HR: 0.34, 95% CI: 0.17-0.70; interaction P=0.009; CSS: HR: 0.32, 95% CI: 0.15-0.67, interaction P=0.008). CONCLUSION The standard D2 dissection provides oncologic outcomes comparable to CME on the 5-year follow-up. However, CME seems to improve 5-year outcomes in patients with stage III, particularly those with pN2 status, and may confer benefit in patients with LVI.

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来源期刊

Annals of surgery 医学-外科

CiteScore

14.40

自引率

4.40%

发文量

687

审稿时长

4 months

期刊介绍： The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.