Center of Gastric Cancer, National Cancer Center, Goyang, Korea.
Department of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Center, Busan, Korea.
J Clin Oncol. 2022 Jul 20;40(21):2342-2351. doi: 10.1200/JCO.21.02242. Epub 2022 Mar 24.
To compare postoperative complications, long-term survival, and quality of life (QOL) after laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG).
Five hundred eighty patients with preoperatively diagnosed stage IA gastric adenocarcinoma (≤ 3 cm) were assigned to undergo either LSG or LSNNS. Observers were not blinded to patient grouping. The primary outcome was 3-year disease-free survival (3y-DFS). Secondary outcomes included postoperative complications, QOL, 3-year disease-specific survival (3y-DSS), and 3-year overall survival (3y-OS).
In total, 527 patients were included in the modified intention-to-treat analysis population for the primary outcome (LSG, 269; LSNNS, 258). Stomach-preserving surgery was performed in 210 patients (81%) in the LSNNS group. During the median follow-up duration, the 3y-DFS rates in the LSG and LSNNS groups were 95.5% and 91.8%, respectively (difference: 3.7%; 95% CI, -0.6 to 8.1). Three patients with recurrence and five with metachronous gastric cancer in the LSNNS group underwent standard surgery. Two patients with distant metastasis in both groups were treated with palliative chemotherapy. The 3y-DSS and 3y-OS rates in the LSG and LSNNS groups were 99.5% and 99.1% ( = .59) and 99.2% and 97.6% ( = .17), respectively. Postoperative complications occurred in 19.0% of the LSG group and 15.5% of the LSNNS group ( = .294). The LSNNS group showed better physical function ( = .015), less symptoms ( < .001), and improved nutrition than the LSG group.
LSNNS did not show noninferiority to LSG for 3y-DFS, with a 5% margin. However, the 3y-DSS and 3y-OS were not different after rescue surgery in cases of recurrence/metachronous gastric cancer, and LSNNS had better long-term QOL and nutrition than LSG.
比较腹腔镜前哨淋巴结导航手术（LSNNS）和腹腔镜标准胃切除术（LSG）的术后并发症、长期生存和生活质量（QOL）。
580 例术前诊断为 IA 期胃腺癌（≤3cm）的患者被分配行 LSG 或 LSNNS。观察者对患者分组不设盲。主要结局为 3 年无病生存率（3y-DFS）。次要结局包括术后并发症、QOL、3 年疾病特异性生存率（3y-DSS）和 3 年总生存率（3y-OS）。
共 527 例患者纳入主要结局的改良意向治疗分析人群（LSG，269 例；LSNNS，258 例）。LSNNS 组中 210 例（81%）行保留胃的手术。在中位随访期间，LSG 和 LSNNS 组的 3y-DFS 率分别为 95.5%和 91.8%（差异：3.7%；95%CI，-0.6 至 8.1）。LSNNS 组 3 例复发患者和 5 例胃外癌患者接受标准手术。两组各有 2 例远处转移患者接受姑息化疗。LSG 和 LSNNS 组的 3y-DSS 和 3y-OS 率分别为 99.5%和 99.1%（=0.59）和 99.2%和 97.6%（=0.17）。LSG 组术后并发症发生率为 19.0%，LSNNS 组为 15.5%（=0.294）。LSNNS 组的身体功能（=0.015）、症状（<0.001）和营养状况（<0.001）均优于 LSG 组。
LSNNS 与 LSG 相比，3y-DFS 无非劣效性，置信区间为 5%。然而，在复发/胃外癌的挽救性手术后，3y-DSS 和 3y-OS 没有差异，LSNNS 的长期 QOL 和营养状况优于 LSG。
