Long-term Survival Outcomes of Laparoscopic Gastrectomy for Advanced Gastric Cancer: Five-year Results of a Phase II Prospective Clinical Trial

ABSTRACT

PURPOSE: Despite an increased acceptance of laparoscopic gastrectomy (LG) in early gastric cancer (EGC), there is insufficient evidence for its oncological safety in advanced gastric cancer (AGC). This is a prospective phase II clinical trial to evaluate the feasibility of LG with D2 lymph node dissection (LND) in AGC. MATERIALS AND METHODS: The primary endpoint was set as 3-year disease-free survival (DFS). The eligibility criteria were as follows 20-80 years of age, cT2N0-cT4aN3, American Society of Anesthesiologists score of 3 or less, and no other malignancy. Patients were enrolled in this single-arm study between November 2008 and May 2012. Exclusion criteria included cT4b or M1, or having final pathologic results as EGC. All patients underwent D2 lymphadenectomy. Three-year DFS rates were estimated by the Kaplan-Meier method. RESULTS: A total of 157 patients were enrolled. The overall local complication rate was 10.2%. Conversion to open surgery occurred in 11 patients (7.0%). The mean follow-up period was 55.0±20.4 months (1–81 months). The cumulative 3-year DFS rates were 76.3% for all stages, and 100%, 89.3%, 100%, 88.0%, 71.4%, and 35.3% for stage IB, IIA, IIB, IIIA, IIIB, and IIIC, respectively. Recurrence was observed in 37 patients (23.6%), including hematogenous (n=6), peritoneal (n=13), locoregional (n=1), distant node (n=8), and mixed recurrence (n=9). CONCLUSIONS: In addition to being technically feasible for treatment of AGC in terms of morbidity, LG with D2 LND for locally advanced gastric cancer showed acceptable 3-year DFS outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT01441336