目前尚不清楚腹腔镜和开腹远端胃切除术在局部晚期胃癌患者中是否产生相似的结果。一项多中心随机临床试验(中国腹腔镜胃肠外科研究[CLASS]-01)的数据显示，与开腹远端胃切除术相比，腹腔镜远端胃切除术的3年无病生存率并不低。报道局部进展期胃癌患者腹腔镜与开放式远端胃切除术的CLASS-01试验的5年总生存数据。

这是一项在中国14个中心进行的非劣效性、开放性、随机临床试验。从2012年9月12日至2014年12月3日，共有1056名符合条件的临床分期为T2、T3或T4a胃癌且无大淋巴结或远处转移的患者入选。最后一次随访是在2019年12月31日。按照部位、年龄、癌症分期和组织学特征分层后，按1:1的比例将受试者随机分配到腹腔镜远端胃切除术(n = 528)或开腹远端胃切除术(n = 528)伴D2淋巴结切除术。更新5年总生存率以比较腹腔镜远端胃切除术和开腹远端胃切除术。所有分析都是在意向性治疗的基础上进行的。此外，对总生存期进行了符合方案和治疗后分析。

来自1039名患者的数据(726名男性[69.9%]；平均[SD]年龄，56.2 [10.7]岁)接受治疗的患者进行分析。5年时，腹腔镜远端胃切除术组和开腹远端胃切除术组的总生存率分别为72.6%和76.3%(对数秩P = .19危害比，1.17；95% CI，0.93-1.48；P = .19)。比较竞争性风险事件后，胃癌相关死亡(风险比为1.14；95% CI，0.87-1.49；P = .34)和其他原因导致的死亡(危害比，1.23；95% CI，0.74-2.05；P = .42)在两组间没有显著差异。不同肿瘤分期组之间的总生存率没有显著差异。这项研究发现，在局部进展期胃癌患者中，由经验丰富的外科医生在高容量专业机构进行腹腔镜远端胃切除术并D2淋巴结切除术，与开腹远端胃切除术相比，其5年总生存率相似。

Abstract

Importance: It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy.

Objective: To report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer.

Design, setting, and patients: This was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019.

Interventions: Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.

Main outcomes and measures: The 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival.

Results: Data from 1039 patients (726 men [69.9%]; mean [SD] age, 56.2 [10.7] years) who received curative therapy were analyzed. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P = .19; hazard ratio, 1.17; 95% CI, 0.93-1.48; P = .19). After comparison for competing risk events, gastric cancer-related deaths (hazard ratio, 1.14; 95% CI, 0.87-1.49; P = .34) and deaths from other causes (hazard ratio, 1.23; 95% CI, 0.74-2.05; P = .42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage.

Conclusions and relevance: This study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer.

原文链接

pubmed.ncbi.nlm.nih.gov/35704479/

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