A nonrandomized, single-arm confirmatory trial of expanded endoscopic submucosal dissection indication for undifferentia
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ORIGINAL ARTICLE
A nonrandomized, single‑arm confirmatory trial of expanded endoscopic submucosal dissection indication for undifferentiated early gastric cancer: Japan Clinical Oncology Group study (JCOG1009/1010) Kohei Takizawa1,2 · Hiroyuki Ono1 · Noriaki Hasuike3 · Atsuo Takashima4 · Keiko Minashi5 · Narikazu Boku6 · Ryoji Kushima7 · Hiroshi Katayama4 · Gakuto Ogawa4 · Haruhiko Fukuda4 · Junko Fujisaki8 · Ichiro Oda9 · Tomonori Yano10 · Shinichiro Hori11 · Hisashi Doyama12 · Kingo Hirasawa13 · Yoshinobu Yamamoto14 · Ryu Ishihara15 · Satoshi Tanabe16 · Yasumasa Niwa17 · Masahiro Nakagawa18 · Masanori Terashima19 · Manabu Muto20 on behalf of the Gastrointestinal Endoscopy Group (GIESG) and the Stomach Cancer Study Group (SCSG) of Japan Clinical Oncology Group Received: 20 August 2020 / Accepted: 16 October 2020 © The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2020
Abstract Background While endoscopic submucosal dissection (ESD) is recognized as a minimally invasive standard treatment for differentiated early gastric cancers (EGCs), it has not been indicated for undifferentiated EGC (UD-EGC) because of a relatively high risk of lymph node metastasis (LNM). However, patients with surgically resected mucosal (cT1a) UD-EGC ≤ 2 cm in size with no lymphovascular invasion or ulceration are reported to be at a very low risk of LNM. This multicenter, singlearm, confirmatory trial was conducted to evaluate the efficacy and safety of ESD for UD-EGC. Methods The key eligibility criteria were endoscopically diagnosed cT1a/N0/M0, single primary lesion, size ≤ 2 cm, no ulceration and histologically proven components of undifferentiated adenocarcinoma on biopsy. Based on the histological findings after ESD, additional gastrectomy was indicated if the criteria for curative resection were not satisfied. The subjects of the primary analysis were patients with UD-EGC as the dominant component. The primary endpoint was 5-year overall survival (OS) of patients with UD-EGC. Results Three hundred 46 patients were enrolled from 49 institutions. The proportion of en bloc resection was 99%. No ESD-related Grade 4 adverse events were noted. Delayed bleeding and intraoperative and delayed perforation occurred in 25 (7.3%), 13 (3.8%), and 6 (1.7%) patients, respectively. Among the 275 patients who were the subjects of the primary analysis, curative resection was achieved in 195 patients (71%), and 5-year OS was 99.3% (95% CI: 97.1–99.8). Conclusions ESD can be a curative and less invasive treatment for UD-EGC for patients meeting the eligibility criteria of this study. Keywords Endoscopy · Gastric cancer · Endoscopic submucosal dissection (ESD) · Gastrectomy · Undifferentiated type
Introduction
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10120-020-01134-9) contains supplementary material, which is available to authorized users. * Kohei Takizawa [email protected] Extended author information available on the last page of the article
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