Long-term survival outcomes of laparoscopic total gastrectomy vs open total gastrectomy in patients with clinical stage I gastric cancer: the CLASS02 randomized clinical trial

BACKGROUND: The long-term survival outcomes for patients with clinical stage I gastric cancer who undergo laparoscopic total gastrectomy (LTG) are still uncertain due to the limited high-level clinical evidence. MATERIAL AND METHODS: The CLASS02 study was designed as a prospective, multicenter, open-label, randomized, non-inferiority clinical trial carried out across 14 gastroenterology centers in China. Patients diagnosed with clinical stage I gastric adenocarcinoma located in the middle and/or upper third of the stomach were randomly assigned to receive either LTG or open total gastrectomy (OTG) accompanied by D1+/D2 lymphadenectomy performed by skilled surgeons. Building on the primary analysis of safety results at 30 days, published in 2020, this extended analysis aimed to evaluate 5-year overall survival (OS) and disease-free survival (DFS) rates between LTG and OTG. RESULTS: Of the 227 patients who were enrolled between January 2017 and September 2018, 214 patients underwent total gastrectomy: 105 (49.0%) in the LTG group and 109 (51.0%) in the OTG group. The 5-year OS rate was 93.3% in the LTG group compared to 94.5% in the OTG group, and the 5-year DFS rate was 92.4% in the LTG group compared to 93.6% in the OTG group. There were no significant differences between the groups. CONCLUSION: Given the current underpowered long-term follow-up findings, LTG with D1 +/D2 lymphadenectomy performed by experienced surgeons showed numerically similar 5-year overall survival and disease-free survival rates to OTG in patients with clinical stage I gastric cancer.