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内镜切除胃癌的长期生存:来自多中心前瞻性队列的真实世界证据。

Long-term Survival After Endoscopic Resection For Gastric Cancer: Real-world Evidence From a Multicenter Prospective Cohort.

机构信息

Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.

Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.

出版信息

Clin Gastroenterol Hepatol. 2023 Feb;21(2):307-318.e2. doi: 10.1016/j.cgh.2022.07.029. Epub 2022 Aug 7.

Abstract

BACKGROUND & AIMS: We aimed to clarify the long-term outcomes of endoscopic resection (ER) for early gastric cancers (EGCs) based on pathological curability in a multicenter prospective cohort study.

METHODS

We analyzed the long-term outcomes of 9054 patients with 10,021 EGCs undergoing ER between July 2010 and June 2012. Primary endpoint was the 5-year overall survival (OS). The hazard ratio for all-cause mortality was calculated using the Cox proportional hazards model. We also compared the 5-year OS with the expected one calculated for the surgically resected patients with EGC. If the lower limit of the 95% confidence interval (CI) of the 5-year OS exceeded the expected 5-year OS minus a margin of 5% (threshold 5-year OS), ER was considered to be effective. Pathological curability was categorized into en bloc resection, negative margins, and negative lymphovascular invasion: differentiated-type, pT1a, ulcer negative, ≤2 cm (Category A1); differentiated-type, pT1a, ulcer negative, >2 cm or ulcer positive, ≤3 cm (Category A2); undifferentiated-type, pT1a, ulcer negative, ≤2 cm (Category A3); differentiated-type, pT1b (SM1), ≤3 cm (Category B); or noncurative resections (Category C).

RESULTS

Overall, the 5-year OS was 89.0% (95% CI, 88.3%-89.6%). In a multivariate analysis, no significant differences were observed when the hazard ratio of Categories A2, A3, and B were compared with that of A1. In all the pathological curability categories, the lower limit of the 95% CI for the 5-year OS exceeded the threshold 5-year OS.

CONCLUSION

ER can be recommended as a standard treatment for patients with EGCs fulfilling Category A2, A3, and B, as well as A1 (UMIN Clinical Trial Registry, UMIN000005871).

摘要

背景与目的

本研究旨在通过多中心前瞻性队列研究,基于病理可治愈性,明确内镜下切除(ER)治疗早期胃癌(EGC)的长期疗效。

方法

我们分析了 2010 年 7 月至 2012 年 6 月间接受 ER 治疗的 9054 例 10021 例 EGC 患者的长期疗效。主要终点为 5 年总生存率(OS)。采用 Cox 比例风险模型计算全因死亡率的风险比。我们还比较了 5 年 OS 与预计的 EGC 手术切除患者的 5 年 OS。如果 5 年 OS 的 95%置信区间(CI)下限超过预期 5 年 OS 减去 5%的裕度(阈值 5 年 OS),则认为 ER 有效。病理可治愈性分为整块切除、无边缘阳性和无淋巴血管侵犯:分化型、pT1a、溃疡阴性、≤2cm(A1 类);分化型、pT1a、溃疡阴性、>2cm 或溃疡阳性、≤3cm(A2 类);未分化型、pT1a、溃疡阴性、≤2cm(A3 类);分化型、pT1b(SM1)、≤3cm(B 类)或非治愈性切除(C 类)。

结果

总体而言,5 年 OS 为 89.0%(95%CI,88.3%-89.6%)。多变量分析显示,A2、A3 和 B 类的危险比与 A1 类无显著差异。在所有病理可治愈性类别中,5 年 OS 的 95%CI 下限均超过阈值 5 年 OS。

结论

对于符合 A2、A3 和 B 类以及 A1 类(UMIN 临床研究注册,UMIN000005871)标准的 EGC 患者,ER 可推荐为标准治疗方法。

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