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机器人全胃切除术治疗局部进展期近端胃癌的长期肿瘤学安全性:基于FUGES-014研究的5年非劣效性比较

[Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study].

作者信息

Zhong Q, Zhang Z Q, Yan Y Q, Li Y F, He Q C, Zheng C H, Chen Q Y, Huang C M

机构信息

Department of Gastric Surgery, the Union Hospital Affiliated to Fujian Medical University, Fuzhou 350001, China.

Union Clinical Medical College, Fujian Medical University, Fuzhou 350000,China.

出版信息

Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218.

Abstract

To report the 5-year survival outcomes and recurrence patterns of robotic total gastrectomy (RTG) for locally advanced proximal gastric cancer in order to provide more valuable long-term follow-up results for clinical practice. This was a prospective, single-arm, open-label clinical trial (FUGES-014; Clinical-Trials.gov, NCT03524287). Patients with locally advanced proximal gastric cancer who underwent RTG at Fujian Medical University Union Hospital from March 5, 2018, to February 10, 2020, were included in the analysis. To evaluate the long-term efficacy of RTG in the most objective manner possible, we performed a propensity score-matched (1∶2) comparative analysis with historical control patients who had undergone laparoscopic total gastrectomy (LTG) from the FUGES-002 study (ClinicalTrials.gov, NCT02333721) in which the 5-year disease-free survival (DFS), 5-year overall survival (OS), and recurrence patterns were compared between the two groups. Prior to matching, there were 48 cases in the RTG group and 263 cases in the LTG group; patients in the LTG group had more advanced cT and pT stages (=0.044 and 0.006, respectively) compared to the RTG group. After matching, there were 48 cases in the RTG group and 96 cases in the LTG group; however, no statistically significant differences were observed in the baseline clinical characteristics between the two groups (all >0.05). Both groups had a median follow-up of 72 months. The 5-year DFS rates were 75.0% (95%CI: 63.7%- 88.3%) in the RTG group and 61.4% (95%CI: 52.5%-72.0%) in the LTG group (=0.116). Similarly, the 5-year OS rates were 79.2% (95%CI: 68.5%-91.5%) and 64.6% (95%CI: 55.7%-74.9%) in the RTG and LTG groups, respectively (=0.100). Within 5 years after surgery, tumor recurrence occurred in 10 patients (20.8%) in the RTG group and 33 patients (34.4%) in the LTG group (=0.124), and peritoneal recurrence was the predominant pattern in both groups (8.3%[4/48] vs. 10.4%[10/96]; risk difference: -0.02,=0.554). Gastric cancer-related death was the predominant cause of death in both groups (16.7% [8/48] vs. 31.2% [30/96]; risk difference: -0.15, =0.064). Among patients stratified by different pathological stages, no statistically significant differences were found in DFS, OS, or recurrence rates between the RTG and LTG groups (all >0.05). We find the long-term oncological outcomes of RTG for locally advanced proximal gastric cancer to be noninferior to those of LTG. RTG should therefore be considered as a valid option for standardized minimally invasive surgery for locally advanced proximal gastric cancer.

摘要

报告机器人全胃切除术(RTG)治疗局部进展期近端胃癌的5年生存结局和复发模式,以便为临床实践提供更有价值的长期随访结果。这是一项前瞻性、单臂、开放标签的临床试验(FUGES - 014;ClinicalTrials.gov,NCT03524287)。纳入分析的患者为2018年3月5日至2020年2月10日在福建医科大学附属协和医院接受RTG治疗的局部进展期近端胃癌患者。为了尽可能客观地评估RTG的长期疗效,我们对FUGES - 002研究(ClinicalTrials.gov,NCT02333721)中接受腹腔镜全胃切除术(LTG)的历史对照患者进行了倾向评分匹配(1∶2)的比较分析,比较了两组的5年无病生存率(DFS)、5年总生存率(OS)和复发模式。匹配前,RTG组有48例,LTG组有263例;与RTG组相比,LTG组患者的cT和pT分期更晚(分别为=0.044和0.006)。匹配后,RTG组有48例,LTG组有96例;然而,两组之间的基线临床特征未观察到统计学显著差异(均>0.05)。两组的中位随访时间均为72个月。RTG组的5年DFS率为75.0%(95%CI:63.7% - 88.3%),LTG组为61.4%(95%CI:52.5% - 72.0%)(=0.116)。同样,RTG组和LTG组的5年OS率分别为79.2%(95%CI:68.5% - 91.5%)和64.6%(95%CI:55.7% - 74.9%)(=0.100)。术后5年内,RTG组有10例患者(20.8%)发生肿瘤复发,LTG组有33例患者(34.4%)发生肿瘤复发(=0.124),两组中腹膜复发均为主要复发模式(8.3%[4/48]对10.4%[10/96];风险差异:-0.02,=0.554)。胃癌相关死亡是两组的主要死亡原因(16.7%[8/48]对31.

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