右侧结肠癌手术治疗的淋巴腺切除范围:随机 III 期 RELARC 试验。

IF 42.1 1区 医学 Q1 ONCOLOGY
Junyang Lu, Jiadi Xing, Lu Zang, Chenghai Zhang, Lai Xu, Guannan Zhang, Zirui He, Yueming Sun, Yifei Feng, Xiaohui Du, Shidong Hu, Pan Chi, Ying Huang, Ziqiang Wang, Ming Zhong, Aiwen Wu, Anlong Zhu, Fei Li, Jianmin Xu, Liang Kang, Jian Suo, Haijun Deng, Yingjiang Ye, Kefeng Ding, Tao Xu, Yuelun Zhang, Zhongtao Zhang, Minhua Zheng, Xiangqian Su, Yi Xiao
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引用次数: 0

摘要

目的:完全结肠系膜切除术(CME)越来越多地被用于治疗右侧结肠癌,但目前仍无有力证据表明CME比D2清扫术能提供更好的长期肿瘤治疗效果。争议主要在于 CME 所强调的扩大淋巴结清扫的生存获益:这项多中心、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。T2-T4aNanyM0期或TanyN + M0期右侧结肠癌患者被随机分配(1:1),在腹腔镜右结肠切除术中接受CME或D2切除术。主要结果是3年无病生存期(DFS),主要次要结果是3年总生存期(OS):2016年1月11日至2019年12月26日期间,1072名患者被随机分配(536名患者接受CME,536名患者接受D2解剖)。共有995名患者(中位年龄61岁,59%为男性)被纳入主要分析(CME [n = 495] v D2夹层 [n = 500])。两组患者的 3 年 DFS(危险比 [HR],0.74 [95% CI,0.54 至 1.02];P = .06;CME 组为 86.1%,D2 组为 81.9%)和 3 年 OS(HR,0.70 [95% CI,0.43 至 1.16];P = .17;CME 组为 94.7%,D2 组为 92.6%)均无明显差异:本试验未能发现在右侧结肠癌的初次手术切除中,CME 的 DFS 结果优于标准 D2 淋巴结清扫术的证据。标准的 D2 淋巴结清扫应成为这些患者的常规手术。只有结肠系膜淋巴结明显受累的患者才应考虑 CME。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial.

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] v 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]; P = .06; 86.1% in the CME group v 81.9% in the D2 group) or in 3-year OS (HR, 0.70 [95% CI, 0.43 to 1.16]; P = .17; 94.7% in the CME group v 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.

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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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