腹腔镜与开腹远端胃癌根治术治疗局部进展期胃癌的五年疗效：CLASS-01 随机临床试验结果

Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial.

机构信息

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

Department of General Surgery, Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers, Nanfang Hospital, Southern Medical University, Guangzhou, China.

出版信息

JAMA Surg. 2022 Jan 1;157(1):9-17. doi: 10.1001/jamasurg.2021.5104.

DOI:10.1001/jamasurg.2021.5104

PMID:34668963

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8529527/

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.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01609309.

摘要

重要性

腹腔镜与开腹远端胃切除术在局部进展期胃癌患者中的疗效是否相似尚不清楚。一项多中心、随机临床试验（Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01）的结果显示，与开腹远端胃切除术相比，腹腔镜远端胃切除术在 3 年内并未导致疾病无进展生存率降低。

目的

报告 CLASS-01 试验中腹腔镜与开腹远端胃切除术治疗局部进展期胃癌患者的 5 年总生存率数据。

设计、设置和患者：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。共有 1056 名符合条件的临床 T2、T3 或 T4a 期胃癌患者（无大淋巴结或远处转移）于 2012 年 9 月 12 日至 2014 年 12 月 3 日入组。最终随访时间为 2019 年 12 月 31 日。

干预措施

参与者按地点、年龄、癌症分期和组织学特征分层后，以 1:1 的比例随机分为腹腔镜远端胃切除术（n = 528）或开腹远端胃切除术（n = 528）加 D2 淋巴结清扫术。

主要结局和测量指标

更新了 5 年总生存率数据，以比较腹腔镜远端胃切除术与开腹远端胃切除术。所有分析均基于意向治疗进行。此外，还进行了总体生存的符合方案和实际治疗分析。

结果

对接受根治性治疗的 1039 名患者（726 名男性[69.9%]；平均[标准差]年龄为 56.2[10.7]岁）的数据进行了分析。5 年时，腹腔镜远端胃切除术组的总生存率为 72.6%，开腹远端胃切除术组为 76.3%（对数秩检验 P = .19；风险比，1.17；95%置信区间，0.93-1.48；P = .19）。在比较竞争风险事件后，胃癌相关死亡（风险比，1.14；95%置信区间，0.87-1.49；P = .34）和其他原因死亡（风险比，1.23；95%置信区间，0.74-2.05；P = .42）两组间无显著差异。各肿瘤分期组间总生存率无显著差异。