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

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37 Citations (Scopus)

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 relapsefree 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 (n5 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 5 .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.

Original languageEnglish
Pages (from-to)3304-3313
Number of pages10
JournalJournal of Clinical Oncology
Volume38
Issue number28
DOIs
Publication statusPublished - 2020 Oct 1

Bibliographical note

Funding Information:
Supported by grants from the National R&D Program for Cancer Control, the Ministry of Health and Welfare, Republic of Korea (1320270), and Ethicon Endo-Surgery and by Johnson & Johnson Company and Jeil Pharmaceutical.

Publisher Copyright:
© 2020 by American Society of Clinical Oncology.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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