Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer The CLASS-01 Randomized Clinical Trial
Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer The CLASS-01 Randomized Clinical Trial
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DOI：
10.1001/jama.2019.5359
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发表时间：
2019-05-28
影响因子：
120.7
通讯作者：
Wang, Baolin
中科院分区：
文献类型：
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作者：
Yu, Jiang;Huang, Changming;Wang, Baolin
腹腔镜远端胃切除术被认为是治疗早期胃癌的一种比传统开放远端胃切除术更有效的方法。然而，局部进展期胃癌的疗效仍不确定。目的比较腹腔镜远端胃切除术或开放性远端胃切除术后局部进展期胃癌患者的3年无病生存率。设计，设置，和PATIENTS The studywas a noninferior，开放标签，随机临床试验，在中国的14个中心。从2012年9月至2014年12月，共入组了1056例符合条件的临床T2、T3或T4 a期胃癌患者，无巨大淋巴结或远处转移。最终随访时间为2017年12月31日。干预参与者按1：1按部位、年龄、癌症分期分层后的比率，主要结果和指标主要终点为3年无病生存率，非劣效性界值为-10%目的比较腹腔镜远端胃切除术与开腹远端胃切除术的疗效。在1056例患者中，1039例（98.4%;平均年龄56.2岁; 313例[30.1%]女性）接受了手术（腹腔镜远端胃切除术[n=519] vs开放远端胃切除术[n=520]），999例（94.6%）完成了研究。腹腔镜远端胃切除术组和开放性远端胃切除术组的3年无病生存率分别为76.5%和77.8%，绝对差异为-1.3%，单侧97.5% CI为-6.5%至无穷大，未超过预先规定的非劣效性界值。三年总生存率（腹腔镜远端胃切除术vs开放远端胃切除术：83.1% vs 85.2%;校正风险比，1.19; 95% CI，0.87 - 1.64; P= 0.28）和3年期间的累积复发率腹腔镜远端胃切除术与开腹远端胃切除术：18.8% vs 16.5%;亚危险比，1.15; 95% CI，0.86 - 1.54; P=.35）在腹腔镜远端胃切除术和开放远端胃切除术组之间没有显著差异。结论和相关性在术前临床分期表明局部进展期胃癌的患者中，腹腔镜远端胃切除术，与开放式远端胃切除术相比，并没有导致3年无病生存率的降低。政府标识符：NCT 01609309
IMPORTANCE Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer. However, efficacy for locally advanced gastric cancer remains uncertain.OBJECTIVE To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy.DESIGN, SETTING, AND PATIENTS The studywas a noninferiority, open-label, randomized clinical trial 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 2012 to December 2014. Final follow-up was on December 31, 2017.INTERVENTIONS Participants were randomized in a 1: 1 ratio after stratification by site, age, cancer stage, and histology to undergo either laparoscopic distal gastrectomy (n=528) or open distal gastrectomy (n=528) with D2 lymphadenectomy.MAIN OUTCOMES AND MEASURES The primary end pointwas 3-year disease-free survival with a noninferiority margin of -10% to compare laparoscopic distal gastrectomy with open distal gastrectomy. Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority.RESULTS Among 1056 patients, 1039 (98.4%; mean age, 56.2 years; 313 [30.1%] women) had surgery (laparoscopic distal gastrectomy [n=519] vs open distal gastrectomy [n=520]), and 999 (94.6%) completed the study. Three-year disease-free survival rate was 76.5% in the laparoscopic distal gastrectomy group and 77.8% in the open distal gastrectomy group, absolute difference of -1.3% and a 1-sided 97.5% CI of -6.5% to infinity, not crossing the prespecified noninferiority margin. Three-year overall survival rate (laparoscopic distal gastrectomy vs open distal gastrectomy: 83.1% vs 85.2%; adjusted hazard ratio, 1.19; 95% CI, 0.87 to 1.64; P=.28) and cumulative incidence of recurrence over the 3-year period (laparoscopic distal gastrectomy vs open distal gastrectomy: 18.8% vs 16.5%; subhazard ratio, 1.15; 95% CI, 0.86 to 1.54; P=.35) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups.CONCLUSIONS AND RELEVANCE Among patients with a preoperative clinical stage indicating locally advanced gastric cancer, laparoscopic distal gastrectomy, compared with open distal gastrectomy, did not result in inferior disease-free survival at 3 years.TRIAL REGISTRATION ClinicalTrials. gov Identifier: NCT01609309