Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial.

IF 55 Q1 Medicine Journal of the American Medical Association Pub Date : 2025-03-04 DOI:10.1001/jama.2024.24276

Ziwei Zeng, Shuangling Luo, Hong Zhang, Miao Wu, Dan Ma, Quan Wang, Ming Xie, Qing Xu, Jun Ouyang, Yi Xiao, Yongchun Song, Bo Feng, Qingwen Xu, Yanan Wang, Yi Zhang, Lishuo Shi, Li Ling, Xingwei Zhang, Liang Huang, Zuli Yang, Junsheng Peng, Xiaojian Wu, Donglin Ren, Meijin Huang, Ping Lan, Jianping Wang, Weidong Tong, Mingyang Ren, Huashan Liu, Liang Kang

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Abstract

Importance: Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME.

Objective: To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer.

Design, setting, and participants: This randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024.

Interventions: Participants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557).

Main outcomes and measures: The primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence.

Results: In the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) for the transanal TME group and 79.4% (97.5% CI, 75.6%-83.4%) for the laparoscopic TME group, with a difference of 2.7% (97.5% CI, -3.0% to 8.1%). The lower tail of a 2-tailed 97.5% CI for the group difference in 3-year disease-free survival was above the noninferiority margin of -10 percentage points. Furthermore, the 3-year local recurrence was 3.6% (95% CI, 2.0%-5.1%) for transanal TME and 4.4% (95% CI, 2.6%-6.1%) for laparoscopic TME. Three-year overall survival was 92.6% (95% CI, 90.4%-94.8%) for transanal TME and 90.7% (95% CI, 88.3%-93.2%) for laparoscopic TME.

Conclusions and relevance: In patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME.

Trial registration: ClinicalTrials.gov Identifier: NCT02966483.

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经肛与腹腔镜直肠全肠系膜切除术和直肠癌3年无病生存率：TaLaR随机临床试验

重要性：先前的研究表明，与腹腔镜下全肠系膜切除术（TME）相比，经肛门全肠系膜切除术（TME）在短期组织病理学结果和并发症方面具有优势。然而，经肛门TME的长期肿瘤学结果仍然不明确。本研究旨在比较经肛门TME和腹腔镜TME的3年无病生存率。目的：评价经肛门TME与腹腔镜TME治疗直肠癌患者的3年无病生存率。设计、环境和参与者：这项随机、开放标签、非劣效性的3期临床试验在中国16个不同的中心进行。2016年4月至2021年6月，共入组1115例临床I - III期中低位直肠癌患者。参与者随访的最后日期是在2024年6月。干预措施：参与者在手术前按1:1的比例随机分配，接受经肛门TME （n = 558）或腹腔镜TME （n = 557）。主要结局和措施：主要终点是3年无病生存，经肛门TME和腹腔镜TME比较的非劣效性裕度为-10%。次要结局包括3年总生存和3年局部复发率。结果：在主要分析集中，患者的中位年龄为60岁。共有692名男性和397名女性患者被纳入分析。经肛门TME组的三年无病生存率为82.1% (97.5% CI, 78.4% ~ 85.8%)，腹腔镜TME组的三年无病生存率为79.4% (97.5% CI, 75.6% ~ 83.4%)，差异为2.7% （97.5% CI, -3.0% ~ 8.1%）。3年无病生存率组差异的双尾97.5% CI的下尾高于-10个百分点的非劣效性裕度。此外，经肛门TME的3年局部复发率为3.6% (95% CI, 2.0%-5.1%)，腹腔镜TME的3年局部复发率为4.4% （95% CI, 2.6%-6.1%）。经肛门TME的三年总生存率为92.6% (95% CI, 90.4%-94.8%)，腹腔镜TME的三年总生存率为90.7% （95% CI, 88.3%-93.2%）。结论及相关性：在中低位直肠癌患者中，经肛门TME的3年无病生存率不低于腹腔镜TME。试验注册：ClinicalTrials.gov标识符：NCT02966483。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of the American Medical Association Medicine-Medicine (all)

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45.40

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期刊介绍： JAMA, published continuously since 1883, is an international peer-reviewed general medical journal. JAMA is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.

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