Clinical Efficacy of Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients with Early Gastric Cancer: 5-year Results of the SENORITA Trial

Abstract

Objective: This study aimed to compare laparoscopic standard gastrectomy (LSG) and laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer (EGC) in terms of 5-year long-term oncologic outcomes. Background: The oncological safety of LSNNS for EGC has not been confirmed. Three-year disease-free survival (DFS), which is the primary endpoint of phase III multicenter randomized controlled clinical trial [SEntinel Node ORIented Tailored Approach (SENORITA) trial], did not show the noninferiority of LSNNS relative to LSG. Methods: The SENORITA trial, a multicenter randomized clinical trial, was designed to show that LSNNS is noninferior to LSG in terms of 3-year DFS. In the present study, we collected 5-year follow-up data from 527 patients recruited in the SENORITA trial as the full analysis set. DFS, overall survival (OS), disease-specific survival (DSS), and recurrence patterns were evaluated using the full analysis set of both LSG (n=269) and LSNNS (n=258). Results: The 5-year DFS was not significantly different between the LSG and LSNNS groups (P=0.0561). During the 5-year follow-up, gastric cancer-related events, such as metachronous cancer, were more frequent in the LSNNS group than in the LSG group. However, 10 recurrent cancers in the remnant stomach of both groups were curatively resected by additional gastrectomy and 1 by additional endoscopic resection. Two of the 198 patients who underwent local resection for stomach preservation based on the LSNNS results developed distant metastasis. However, there was no statistically significant difference in the 5-year OS and DSS (P=0.7403 and P=0.9586, respectively) between the two groups. Conclusions: The 5-year DFS, DSS, and OS did not differ significantly between the two groups. Considering the benefits of LSNNS on postoperative quality of life, LSNNS could be recommended as an alternative treatment option for EGC.