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腹腔镜全胃切除术联合保留脾脏贲门周围淋巴结清扫术治疗局部进展期近端胃癌的疗效:一项非随机临床试验。

Outcomes of Laparoscopic Total Gastrectomy Combined With Spleen-Preserving Hilar Lymphadenectomy for Locally Advanced Proximal Gastric Cancer: A Nonrandomized Clinical Trial.

机构信息

Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.

Fujian Medicine University, Teaching Hospital, The First Hospital of PuTian City, Putian, China.

出版信息

JAMA Netw Open. 2021 Dec 1;4(12):e2139992. doi: 10.1001/jamanetworkopen.2021.39992.

DOI:10.1001/jamanetworkopen.2021.39992
PMID:34928353
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8689389/
Abstract

IMPORTANCE

The long-term survival of patients with laparoscopic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy (LSTG) for advanced upper-third gastric cancer (AUTGC) and the association of splenic hilar lymph node (LN-10) metastasis with survival remain controversial.

OBJECTIVE

To evaluate the long-term outcomes of LSTG and the value index of LN-10 metastasis for patients with AUTGC.

DESIGN, SETTING, AND PARTICIPANTS: The Chinese Laparoscopic Gastrointestinal Surgery Study 4 (CLASS-04) was a prospective, multicenter, single-arm trial that involved 19 centers in China. A total of 251 eligible patients with clinical stage T2, T3, or T4a upper-third gastric cancer without distant metastases were enrolled from September 1, 2016, to October 31, 2017. The final follow-up was on December 31, 2020.

INTERVENTIONS

All patients were enrolled to undergo LSTG.

MAIN OUTCOMES AND MEASURES

The main outcomes were the 3-year overall survival (OS) and disease-free survival (DFS). Multivariate analyses were used to explore the association of LN-10 metastasis with survival.

RESULTS

Among the 251 patients, 246 (98.0%; mean [SD] age, 60.1 [9.4] years; 197 [80.1%] male) underwent LSTG and completed the study. The 3-year OS was 79.1% (95% CI, 74.0%-84.2%), and the 3-year DFS was 73.1% (95% CI, 67.4%-78.8%). In addition, the 3-year therapeutic value index of LN-10 dissection was 4.5, exceeding the indexes for the partial D2 LN group (including LNs 5, 6, 11d, and 12a). Nineteen patients (7.7%) with LN-10 metastasis had significantly worse survival than the nonmetastasis group, and multivariate analysis revealed that splenic LN-10 metastasis was an independent risk factor (OS: hazard ratio [HR], 2.38; 95% CI, 1.08-5.26; P = .03; DFS: HR, 2.28; 95% CI, 1.12-4.63; P = .02). Moreover, patients with LN-10 metastasis were more likely to have recurrence (42.1% vs 20.7%, P = .03), especially when multiple site metastasis was present (21.1% vs 4.4%, P = .01). However, patients with LN-10 metastasis who received adjuvant chemotherapy had significantly better OS and DFS than those without adjuvant chemotherapy and achieved the same oncologic effect as those without LN-10 metastasis.

CONCLUSIONS AND RELEVANCE

This results of this study suggest that LSTG for AUTGC has feasible long-term outcomes. In addition, patients with LN-10 metastasis may have worse survival and may be more prone to recurrence.

摘要

重要性

对于进展期胃上部三分之一癌(AUTGC),腹腔镜全胃切除术联合保留脾脏脾门淋巴结清扫术(LSTG)的患者长期生存情况以及脾门淋巴结(LN-10)转移与生存的关系仍存在争议。

目的

评估 LSTG 治疗 AUTGC 的长期疗效,以及 LN-10 转移对患者生存的价值指标。

设计、地点和参与者:中国腹腔镜胃肠外科研究 4 号(CLASS-04)是一项前瞻性、多中心、单臂试验,涉及中国 19 个中心。2016 年 9 月 1 日至 2017 年 10 月 31 日,共纳入 251 名临床分期为 T2、T3 或 T4a 期无远处转移的胃上部三分之一癌患者。最终随访时间为 2020 年 12 月 31 日。

干预措施

所有患者均被纳入行 LSTG。

主要结局和测量指标

主要结局为 3 年总生存率(OS)和无病生存率(DFS)。采用多变量分析探讨 LN-10 转移与生存的关系。

结果

在 251 名患者中,246 名(98.0%;平均[SD]年龄,60.1[9.4]岁;197 名[80.1%]为男性)行 LSTG 并完成了研究。3 年 OS 为 79.1%(95%CI,74.0%-84.2%),3 年 DFS 为 73.1%(95%CI,67.4%-78.8%)。此外,LN-10 清扫术的 3 年治疗价值指数为 4.5,超过了部分 D2 LN 组(包括 LN5、6、11d 和 12a)的指数。19 名(7.7%)有 LN-10 转移的患者生存明显差于无转移组,多变量分析显示脾 LN-10 转移是独立的危险因素(OS:风险比[HR],2.38;95%CI,1.08-5.26;P=0.03;DFS:HR,2.28;95%CI,1.12-4.63;P=0.02)。此外,有 LN-10 转移的患者更有可能发生复发(42.1%比 20.7%,P=0.03),尤其是多发部位转移(21.1%比 4.4%,P=0.01)。然而,有 LN-10 转移且接受辅助化疗的患者 OS 和 DFS 明显优于未接受辅助化疗且与无 LN-10 转移患者的生存情况相同,达到相同的肿瘤学效果。

结论和相关性

本研究结果表明,LSTG 治疗 AUTGC 具有可行的长期疗效。此外,有 LN-10 转移的患者可能生存情况较差,且更易复发。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77b8/8689389/d70067ac7dde/jamanetwopen-e2139992-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77b8/8689389/4b7a48e171a6/jamanetwopen-e2139992-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77b8/8689389/d70067ac7dde/jamanetwopen-e2139992-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77b8/8689389/4b7a48e171a6/jamanetwopen-e2139992-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77b8/8689389/d70067ac7dde/jamanetwopen-e2139992-g002.jpg

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