National Cancer Center, Goyang, Korea, Republic of (South)
Young Woo Kim , Byung-Ho Nam , Young-Joon Lee , Youngkyu Park , Sang Eog Lee , Oh Jeong , Jun Ho Lee , Ki Young Yoon , Sang-Ho Jeong , Oh Kyoung Kwon , Taebong Kim , Wansik Yu , Young sook Kim , Mira Han , Susie Kim , Keun Won Ryu
Background: For advanced gastric cancer (AGC), D2 gastrectomy is the standard treatment. However, a laparoscopic D2 gastrectomy(LG) is technically challenging surgery. Our previous report of COACT 1001 study, which is randomized phase II study to evaluate the feasibility of LG compared with open surgery(OG) for AGC, showing primary endpoint of non-compliance of lymph node dissection and three-year disease-free survival supported role of LG for AGC. Herein we report five-year overall and disease-free survival outcome of the study. Methods: Patients with cT2-T4a and cN0-2 (AJCC 7th staging system) distal gastric cancer were randomly but not blindingly assigned to LG or OG groups. Patients were followed up for recurrence and survival for 5 years. Results: Between Jun 2010 and Oct 2011, 204 patients were enrolled and underwent either LADG (n = 105) or ODG (n = 99). Of those, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the five- year overall survival between LG and OG groups (85.1% vs 84.1%, respectively; p = 0.749). In the subgroup analysis, five-year overall survival was not different in between the groups according to the clinical stage (stage I: 95.7 % vs 95.5 %; p = 0.988, stage II: 96.1 % vs 84.6 %; p = 0.057, stage III: 48.3 % vs 74.1 %; p = 0.156) and pathological stage (stage I: 97.5 % vs 94.4 %; p = 0.512, stage II: 100 % vs 90.8 %; p = 0.099, stage III: 48.7 % vs 72.7 %; p = 0.151, stage IV: 100 % vs 0 %; p = 0.18). Five-year disease-free survival also was not significantly different between two groups (74.5 % vs 78.7 %, respectively; p = 0.604). The trend of overall and disease-free survival was favorable for LG in stage II but OG in stage III. Conclusions: LG was feasible for AGC based on the five-year overall and disease-free survival rate. Further research should be done in large scale for stage III gastric cancer. Clinical trial information: NCT01088204
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