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Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial

 Woo Jin Hyung  ;  Han-Kwang Yang  ;  Young-Kyu Park  ;  Hyuk-Joon Lee  ;  Ji Yeong An  ;  Wook Kim  ;  Hyoung-Il Kim  ;  Hyung-Ho Kim  ;  Seung Wan Ryu  ;  Hoon Hur  ;  Min-Chan Kim  ;  Seong-Ho Kong  ;  Gyu Seok Cho  ;  Jin-Jo Kim  ;  Do Joong Park  ;  Keun Won Ryu  ;  Young Woo Kim  ;  Jong Won Kim  ;  Joo-Ho Lee  ;  Sang-Uk Han 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.38(28) : 3304-3313, 2020-10 
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Purpose: It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy. The noninferiority of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer compared with open surgery in terms of 3-year relapse-free survival rate was evaluated. Patients and methods: A phase III, open-label, randomized controlled trial was conducted for patients with histologically proven locally advanced gastric adenocarcinoma suitable for distal subtotal gastrectomy. The primary end point was the 3-year relapse-free survival rate; the upper limit of the hazard ratio (HR) for noninferiority was 1.43 between the laparoscopic and open distal gastrectomy groups. Results: From November 2011 to April 2015, 1,050 patients were randomly assigned to laparoscopy (n = 524) or open surgery (n = 526). After exclusions, 492 patients underwent laparoscopic surgery and 482 underwent open surgery and were included in the analysis. The laparoscopy group, compared with the open surgery group, suffered fewer early complications (15.7% v 23.4%, respectively; P = .0027) and late complications (4.7% v 9.5%, respectively; P = .0038), particularly intestinal obstruction (2.0% v 4.4%, respectively; P = .0447). The 3-year relapse-free survival rate was 80.3% (95% CI, 76.0% to 85.0%) for the laparoscopy group and 81.3% (95% CI, 77.0% to 85.0%; log-rank P = .726) for the open group. Cox regression analysis after stratification by the surgeon revealed an HR of 1.035 (95% CI, 0.762 to 1.406; log-rank P = .827; P for noninferiority = .039). When stratified by pathologic stage, the HR was 1.020 (95% CI, 0.751 to 1.385; log-rank P = .900; P for noninferiority = .030). Conclusion: Laparoscopic distal gastrectomy with D2 lymphadenectomy was comparable to open surgery in terms of relapse-free survival for patients with locally advanced gastric cancer. Laparoscopic distal gastrectomy with D2 lymphadenectomy could be a potential standard treatment option for locally advanced gastric cancer.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jong Won(김종원)
Kim, Hyoung Il(김형일) ORCID logo https://orcid.org/0000-0002-6134-4523
Hyung, Woo Jin(형우진) ORCID logo https://orcid.org/0000-0002-8593-9214
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