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右侧结肠癌手术治疗的淋巴结清扫范围:随机 III 期 RELARC 试验。

Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial.

机构信息

Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China.

出版信息

J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.

Abstract

PURPOSE

Complete mesocolic excision (CME) is being increasingly used for the treatment of right-sided colon cancer, although there is still no strong evidence that CME provides better long-term oncological outcomes than D2 dissection. The controversy is mainly regarding the survival benefit from extended lymph node dissection emphasized by CME.

METHODS

This multicenter, open-label, randomized controlled trial (ClinicalTrials.gov identifier: NCT02619942) was performed across 17 hospitals in China. Patients diagnosed with stage T2-T4aNanyM0 or TanyN + M0 right-sided colon cancer were randomly assigned (1:1) to undergo either CME or D2 dissection during laparoscopic right colectomy. The primary outcome was the 3-year disease-free survival (DFS), and the main secondary outcome was the 3-year overall survival (OS).

RESULTS

Between January 11, 2016, and December 26, 2019, 1,072 patients were randomly assigned (536 patients to CME and 536 patients to D2 dissection). In total, 995 patients (median age 61 years, 59% male) were included in the primary analysis (CME [n = 495] D2 dissection [n = 500]). No significant differences were found between the groups in 3-year DFS (hazard ratio [HR], 0.74 [95% CI, 0.54 to 1.02]; = .06; 86.1% in the CME group 81.9% in the D2 group) or in 3-year OS (HR, 0.70 [95% CI, 0.43 to 1.16]; = .17; 94.7% in the CME group 92.6% in the D2 group).

CONCLUSION

This trial failed to find evidence of superior DFS outcome for CME compared with standard D2 lymph node dissection in primary surgical excision of right-sided colon cancer. Standard D2 dissection should be the routine procedure for these patients. CME should only be considered in patients with obvious mesocolic lymph node involvement.

摘要

目的

完整结肠系膜切除术(CME)越来越多地用于治疗右侧结肠癌,尽管目前尚无强有力的证据表明 CME 比 D2 清扫术提供更好的长期肿瘤学结果。争议主要集中在 CME 强调的扩大淋巴结清扫术带来的生存获益上。

方法

本多中心、开放标签、随机对照试验(ClinicalTrials.gov 标识符:NCT02619942)在中国 17 家医院进行。诊断为 T2-T4aNanyM0 或 TanyN+M0 右侧结肠癌的患者被随机分为(1:1)接受腹腔镜右结肠切除术时行 CME 或 D2 清扫术。主要结局是 3 年无病生存率(DFS),主要次要结局是 3 年总生存率(OS)。

结果

2016 年 1 月 11 日至 2019 年 12 月 26 日,共 1072 例患者被随机分配(CME 组 536 例,D2 组 536 例)。共有 995 例患者(中位年龄 61 岁,59%为男性)纳入主要分析(CME 组 [n=495] D2 组 [n=500])。两组患者 3 年 DFS(风险比 [HR],0.74 [95%CI,0.54 至 1.02]; =.06;CME 组为 86.1%,D2 组为 81.9%)或 3 年 OS(HR,0.70 [95%CI,0.43 至 1.16]; =.17;CME 组为 94.7%,D2 组为 92.6%)均无显著差异。

结论

本试验未能发现 CME 在右侧结肠癌的初始手术切除中与标准 D2 淋巴结清扫术相比,DFS 结果有优势的证据。标准 D2 清扫术应作为这些患者的常规手术。CME 仅应考虑在有明显结肠系膜淋巴结受累的患者中进行。

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