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

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Author(s)
Woo Jin HyungHan-Kwang YangYoung-Kyu ParkHyuk-Joon LeeJi Yeong AnWook KimHyoung-Il KimHyung-Ho KimSeung Wan RyuHoon HurMin-Chan KimSeong-Ho KongGyu Seok ChoJin-Jo KimDo Joong ParkKeun Won RyuYoung Woo KimJong Won KimJoo-Ho LeeSang-Uk Han
Keimyung Author(s)
Ryu, Seung Wan
Department
Dept. of Surgery (외과학)
Journal Title
Journal of Clinical Oncology
Issued Date
2020
Volume
38
Issue
28
Abstract
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.
Keimyung Author(s)(Kor)
류승완
Publisher
School of Medicine (의과대학)
Citation
Woo Jin Hyung et al. (2020). Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial. Journal of Clinical Oncology, 38(28), 3304–3313. doi: 10.1200/JCO.20.01210
Type
Article
ISSN
1527-7755
Source
https://ascopubs.org/doi/10.1200/JCO.20.01210
DOI
10.1200/JCO.20.01210
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43159
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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