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. 2023 May 1;158(5):445-454.
doi: 10.1001/jamasurg.2023.0096.

Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer: The JLSSG0901 Randomized Clinical Trial

Tsuyoshi Etoh  1 , Tetsuji Ohyama  2 , Shinichi Sakuramoto  3 , Toshikatsu Tsuji  4 , Sang-Woong Lee  5 , Kazuhiro Yoshida  6 , Keisuke Koeda  7 , Naoki Hiki  8 , Chikara Kunisaki  9 , Masanori Tokunaga  10 , Dai Otsubo  11 , Akinori Takagane  12 , Kazunari Misawa  13 , Takahiro Kinoshita  14 , Haruhiko Cho  15 , Yuichiro Doki  16 , Souya Nunobe  17 , Norio Shiraishi  18 , Seigo Kitano  19 ; Japanese Laparoscopic Surgery Study Group (JLSSG)
Collaborators, Affiliations

Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer: The JLSSG0901 Randomized Clinical Trial

Tsuyoshi Etoh et al. JAMA Surg. .

Abstract

Importance: Evidence of implementation of laparoscopic gastrectomy for locally advanced gastric cancer is currently insufficient, as the primary end point in previous prospective studies was evaluated at a median follow-up time of 3 years. More robust evidence is necessary to verify noninferiority of laparoscopic gastrectomy.

Objective: To compare 5-year survival outcomes between laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer.

Design, setting, and participants: This was a multicenter, open-label, noninferiority, prospective randomized clinical trial. Between November 26, 2009, and July 29, 2016, eligible patients with histologically proven gastric carcinoma from 37 institutes in Japan were enrolled. Two interim analyses and final analysis were performed in October 2014, May 2018, and November 2021, respectively.

Interventions: Patients were randomly assigned (1:1) to either the ODG or LADG group. The procedures were performed exclusively by qualified surgeons.

Main outcomes and measures: The primary end point was 5-year relapse-free survival, and the noninferiority margin for the hazard ratio (HR) was set at 1.31. The secondary end points were 5-year overall survival and safety.

Results: A total of 502 patients were included in the full-analysis set: 254 (50.6%) in the ODG group and 248 (49.4%) in the LADG group. Patients in the ODG group had a median (IQR) age of 67 (33-80) years and included 168 males (66.1%). Patients in the LADG group had a median (IQR) age of 64 (34-80) years and included 169 males (68.1%). No significant differences were observed in severe postoperative complications between the 2 groups in the safety analysis (ODG, 4.7% [11 of 233] vs LADG, 3.5% [8 of 227]; P = .64). The median (IQR) follow-up for all patients after randomization was 67.9 (60.3-92.0) months. The 5-year relapse-free survival was 73.9% (95% CI, 68.7%-79.5%) and 75.7% (95% CI, 70.5%-81.2%) for the ODG and LADG groups, respectively, and the HR was 0.96 (90% CI, 0.72-1.26; noninferiority 1-sided P = .03). Further, no significant difference was observed in overall survival time between the 2 groups, and the HR was 0.83 (95% CI, 0.57-1.21; P = .34). The pattern of recurrence was similar between the 2 groups.

Conclusions and relevance: Results of this study show that on the basis of 5-year follow-up data, LADG with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to ODG. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer.

Trial registration: UMIN Clinical Trial Registry: UMIN000003420.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Yoshida reported receiving grants from Abbott, AbbVie, Asahi Kasei Pharma, Astellas, Biogen Japan, Celgene, Chugai Pharma, Covidien Japan, Daiichi Sankyo, Eisai, Eli Lilly Japan, EP-CRSU, EPS Corporation, Fujifilm, GlaxoSmithKline, Johnson & Johnson, Kaken Pharma, Kyowa Kirin, Meiji Seika Pharma, MSD, Nippon Kayaku, Novartis, Ono Pharma, Otsuka Pharma, Philips Japan, Sanofi, ShiftZero KK, Taiho Pharma, Terumo Corp, Tsumura, and Yakult Honsha and personal fees from AstraZeneca, Bristol Myers Squibb, Chugai Pharma, Covidien Japan, Daiichi Sankyo, EA Pharma, Eli Lilly Japan, Intuitive Surgical GK, Johnson & Johnson, Medical Review Co, MSD, Nippon Kayaku, Ono Pharma, Otsuka Pharma, Pfizer, Sanofi, Sanwa Kagaku Kenkyusho, Taiho Pharma, Takeda Pharma, Teijin Pharma, Terumo Corp, Tsumura, Usaco, and Yakult Honsha outside the submitted work. Dr Hiki reported receiving grants from Abbott Japan, EA Pharma, Johnson & Johnson, Otsuka Pharma, Otsuka Pharmaceutical Factory, Kaken Pharma, Covidien Japan, Shionogi & Co, Takeda Pharma, Daiichi Sankyo, Taiho Pharma, Chugai Pharma, Tsumura & Co, Terumo Corp, Hogy Medical Co, Miyarisan Pharma, and Yakult Honsha Co and personal fees from Abbott Japan LLC, EA Pharma Co, Johnson & Johnson, Otsuka Pharma, Taiho Pharma, Chugai Pharma, Tsumura & Co, Terumo Corp, Hogy Medical Co, Miyarisan Pharma, Yakult Honsha Co, NHK, Pfizer Japan, AstraZeneca KK, Nihon Pharma, Olympus Medical Science Sales Corporation, Novartis Pharma KK, Intuitive Surgical GK, Ono Pharma, Kaigen Pharma Co, QLife Inc, Sumitomo Dainippon Pharma, Nestlé Japan, Otsuka Pharmaceutical Factory, Kaken Pharma, Covidien Japan, Shionogi & Co, Takeda Pharma, and Daiichi Sankyo outside the submitted work. Dr Kunisaki reported receiving grants from Taiho Pharma, Chugai Pharma, and Yakult Honsha Co outside the submitted work. Dr Cho reported receiving personal fees from Ethicon outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Consolidated Standards for Reporting Trials (CONSORT) Diagram
The full-analysis set (FAS) excluding ineligible patients and those who withdrew was included in the efficacy analysis. LADG indicates laparoscopy-assisted distal gastrectomy; LN, lymph node; ODG, open distal gastrectomy; PPS, per-protocol set.
Figure 2.
Figure 2.. Survival Analyses
A, Relapse-free survival in the full-analysis set (FAS) analysis. B, Relapse-free survival in the per-protocol set (PPS) analysis. C, Overall survival in the FAS analysis. D, Overall survival in the PPS analysis. LADG indicates laparoscopy-assisted distal gastrectomy; ODG, open distal gastrectomy.
Figure 3.
Figure 3.. Subgroup Analysis of Relapse-Free Survival
BMI indicates body mass index; HR, hazard ratio; LADG, laparoscopy-assisted distal gastrectomy; MP, muscularis propria; N, node; ODG, open distal gastrectomy; SE, serosal exposure; SS, subserosa; T, tumor. aCalculated as weight in kilograms divided by height in meters squared. bClinical stage indicates the following: stage IB, T1N1M0 or T2N0M0; stage II, T1N2M0 or T1N3M0 or T2N1M0 or T2N2M0 or T3N0M0; stage III, T2N3M0 or T3N2-3M0 or T4N1-N3M0. cClinical N category indicates the following: N0, no regional lymph node metastasis; N+, metastasis in lymph nodes. Pathological N category indicates the following: N0, no regional lymph node metastasis; N1, metastasis in 1 to 2 regional lymph nodes; N2, metastasis in 3 to 6 regional lymph nodes; N3, metastasis in 7 or more regional lymph nodes. dClinical and pathological T category indicates the following: T2, tumor invasion of MP; T3, tumor invasion of SS; T4, SE or tumor invades adjacent structures.
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