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Long-term Survival After Endoscopic Resection For Gastric Cancer: Real-world Evidence From a Multicenter Prospective Cohort
Clinical Gastroenterology and Hepatology ( IF 12.6 ) Pub Date : 2022-08-07 , DOI: 10.1016/j.cgh.2022.07.029
Haruhisa Suzuki 1 , Hiroyuki Ono 2 , Toshiaki Hirasawa 3 , Yoji Takeuchi 4 , Kenji Ishido 5 , Shu Hoteya 6 , Tomonori Yano 7 , Shinji Tanaka 8 , Yosuke Toya 9 , Masahiro Nakagawa 10 , Takashi Toyonaga 11 , Kenichi Takemura 12 , Kingo Hirasawa 13 , Mitsuru Matsuda 14 , Hironori Yamamoto 15 , Yosuke Tsuji 16 , Satoru Hashimoto 17 , Maeda Yuki 2 , Tsuneo Oyama 18 , Ryuta Takenaka 19 , Yoshinobu Yamamoto 20 , Yuji Naito 21 , Katsumi Yamamoto 22 , Nozomu Kobayashi 23 , Yoshiro Kawahara 24 , Masaaki Hirano 25 , Shigeto Koizumi 26 , Shinichiro Hori 27 , Masahiro Tajika 28 , Takuto Hikichi 29 , Kenshi Yao 30 , Chizu Yokoi 31 , Ken Ohnita 32 , Yasuhiro Hisanaga 33 , Tetsuya Sumiyoshi 34 , Shinji Kitamura 35 , Hisao Tanaka 36 , Ryo Shimoda 37 , Taichi Shimazu 38 , Kohei Takizawa 2 , Satoshi Tanabe 39 , Hitoshi Kondo 34 , Hiroyasu Iishi 40 , Motoki Ninomiya 41 , Ichiro Oda 1 ,
Affiliation  

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).



中文翻译:

胃癌内镜下切除术后的长期生存:来自多中心前瞻性队列的真实世界证据

背景与目标

我们的目的是在多中心前瞻性队列研究中阐明基于病理可治愈性的早期胃癌 (EGC) 内镜切除术 (ER) 的长期结果。

方法

我们分析了 2010 年 7 月至 2012 年 6 月期间接受 ER 的 9054 名患者的长期结果,其中 10,021 个 EGC。主要终点是 5 年总生存期 (OS)。使用 Cox 比例风险模型计算全因死亡率的风险比。我们还将 5 年 OS 与为手术切除的 EGC 患者计算的预期 OS 进行了比较。如果 5 年 OS 的 95% 置信区间 (CI) 下限超过预期 5 年 OS 减去 5% 的差值(5 年 OS 阈值),则认为 ER 有效。病理治愈分为整块切除、切缘阴性、淋巴血管浸润阴性:分化型、pT1a、溃疡阴性、≤2cm(A1类);分化型,pT1a,溃疡阴性,>2 cm 或溃疡阳性,≤3 cm(A2 类);未分化型,pT1a,溃疡阴性,≤2 cm(A3 类);分化型,pT1b (SM1),≤3 cm(B 类);或非治愈性切除术(C 类)。

结果

总体而言,5 年 OS 为 89.0%(95% CI,88.3%–89.6%)。在多变量分析中,将 A2、A3 和 B 类的风险比与 A1 类的风险比进行比较时,未观察到显着差异。在所有病理治愈类别中,5 年 OS 的 95% CI 下限超过了 5 年 OS 阈值。

结论

ER 可推荐作为符合 A2、A3 和 B 类以及 A1 类的 EGC 患者的标准治疗(UMIN 临床试验注册中心,UMIN000005871)。

更新日期:2022-08-07
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