Woo Jin Hyung1, Han-Kwang Yang2, Young-Kyu Park3, Hyuk-Joon Lee2, Ji Yeong An1, Wook Kim4, Hyoung-Il Kim1, Hyung-Ho Kim5, Seung Wan Ryu6, Hoon Hur7, Min-Chan Kim8, Seong-Ho Kong2, Gyu Seok Cho9, Jin-Jo Kim10, Do Joong Park5, Keun Won Ryu11, Young Woo Kim11, Jong Won Kim12, Joo-Ho Lee13, Sang-Uk Han7. 1. Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea. 2. Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea. 3. Department of Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea. 4. Department of Surgery, Yeouido St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 5. Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. 6. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea. 7. Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea. 8. Department of Surgery, Dong-A University Hospital, Korea, Busan, Republic of Korea. 9. Department of Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea. 10. Department of Surgery, Incheon St Mary's Hospital, The Catholic University of Korea, Incheon, Republic of Korea. 11. Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea. 12. Department of Surgery, Yonsei University Gangnam Severance Hospital, Seoul, Republic of Korea. 13. Department of Surgery, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.
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.
RCT Entities:
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.
Authors: Marcus Fernando Kodama Pertille Ramos; Marina Alessandra Pereira; André Roncon Dias; Ulysses Ribeiro; Bruno Zilberstein; Sergio Carlos Nahas Journal: Updates Surg Date: 2021-06-04