Hatta Waku, Gotoda Takuji, Oyama Tsuneo, Kawata Noboru, Takahashi Akiko, Yoshifuku Yoshikazu, Hoteya Shu, Nakagawa Masahiro, Hirano Masaaki, Esaki Mitsuru, Matsuda Mitsuru, Ohnita Ken, Yamanouchi Kohei, Yoshida Motoyuki, Dohi Osamu, Takada Jun, Tanaka Keiko, Yamada Shinya, Tsuji Tsuyotoshi, Ito Hirotaka, Hayashi Yoshiaki, Nakaya Naoki, Nakamura Tomohiro, Shimosegawa Tooru
Department of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Am J Gastroenterol. 2017 Jun;112(6):874-881. doi: 10.1038/ajg.2017.95. Epub 2017 Apr 11.
Although radical surgery is recommended for patients not meeting the curative criteria for endoscopic submucosal dissection (ESD) of early gastric cancer (EGC) because of the potential risk of lymph node metastasis (LNM), this recommendation may be overestimated and excessive. We aimed to establish a simple scoring system for decision making after ESD.
This multicenter retrospective study consisted of two stages. First, the risk-scoring system for LNM was developed using multivariate logistic regression analysis in 1,101 patients who underwent radical surgery after having failed to meet the curative criteria for ESD of EGC. Next, the system was internally validated by survival analysis in another 905 patients who also did not meet the criteria and did not receive additional treatment after ESD.
In the development stage, based on accordant regression coefficients, five risk factors for LNM were weighted with point values: three points for lymphatic invasion and 1 point each for tumor size >30 mm, positive vertical margin, venous invasion, and submucosal invasion ≥500 μm. Then, the patients were categorized into three LNM risk groups: low (0-1 point: 2.5% risk), intermediate (2-4 points: 6.7%), and high (5-7 points: 22.7%). In the validation stage, cancer-specific survival differed significantly among these groups (99.6, 96.0, and 90.1%, respectively, at 5 years; P<0.001). The C statistic of the system for cancer-specific mortality was 0.78.
This scoring system predicted cancer-specific survival in patients who did not meet the curative criteria after ESD for EGC. ESD without additional treatment may be an acceptable option for patients at low risk.
尽管对于因存在淋巴结转移（LNM）潜在风险而不符合早期胃癌（EGC）内镜黏膜下剥离术（ESD）治愈标准的患者，推荐进行根治性手术，但这一推荐可能被高估且过度。我们旨在建立一个用于ESD术后决策的简单评分系统。
这项多中心回顾性研究包括两个阶段。首先，在1101例因不符合EGC的ESD治愈标准而接受根治性手术的患者中，使用多因素逻辑回归分析建立LNM风险评分系统。接下来，在另外905例同样不符合标准且ESD术后未接受额外治疗的患者中，通过生存分析对该系统进行内部验证。
在开发阶段，根据一致的回归系数，对五个LNM风险因素赋予分值：淋巴管侵犯为3分，肿瘤大小>30 mm、垂直切缘阳性、静脉侵犯和黏膜下侵犯≥500μm各为1分。然后，将患者分为三个LNM风险组：低风险（0 - 1分：风险2.5%）、中风险（2 - 4分：6.7%）和高风险（5 - 7分：22.7%）。在验证阶段，这些组之间的癌症特异性生存率有显著差异（5年时分别为99.6%、96.0%和90.1%；P<0.001）。该系统用于癌症特异性死亡率的C统计量为0.78。
该评分系统可预测EGC患者ESD术后未达治愈标准时的癌症特异性生存率。对于低风险患者，不进行额外治疗的ESD可能是一个可接受的选择。
