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Gastric Cancer. 2018 Jan;21(1):114-123. doi: 10.1007/s10120-017-0704-y. Epub 2017 Feb 21.

A non-randomized confirmatory trial of an expanded indication for endoscopic submucosal dissection for intestinal-type gastric cancer (cT1a): the Japan Clinical Oncology Group study (JCOG0607).

Author information

1
Gastrointestinal Center and Institute of Minimally Invasive Endoscopic Care (iMEC), Sano Hospital, Kobe, 5-21 Shimizugaoka, Tarumi-Ku, Kobe, 655-0031, Japan. nhasuike11@gmail.com.
2
Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
3
Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
4
Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
5
Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
6
Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
7
Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
8
Department of Endoscopy, Shikoku Cancer Center, Matsuyama, Japan.
9
Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
10
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
11
Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Abstract

BACKGROUND:

Endoscopic resection has been limited to intestinal-type gastric cancer (cT1a) with a low risk of lymph node metastasis (T1a ≤2 cm, without ulcers). This single-arm confirmatory trial evaluated the efficacy and safety of endoscopic submucosal dissection (ESD) for >2 cm ulcer-negative and ≤3 cm ulcer-positive intestinal-type gastric cancer (cT1a).

METHODS:

The eligibility criteria included endoscopically diagnosed cT1a, a single primary intestinal-type gastric adenocarcinoma, an ulcer-negative lesion of any size or a ≤3 cm ulcer-positive lesion, cN0M0, and no prior treatment. If ESD resulted in noncurative resection, surgical resection was added. The primary endpoint was the 5-year overall survival (OS) (planned sample size was 470, with a one-sided alpha level of 2.5%). The threshold 5-year OS was 86.1%.

RESULTS:

We enrolled 470 early gastric cancer patients [median tumor size, 25 (5-130) mm] from 29 institutions between June 2007 and October 2010. These patients had 152 ulcer-negative lesions (>2 and ≤3 cm), 111 ulcer-negative lesions (>3 cm), and 207 ulcer-positive lesions (≤3 cm). The success rate for en block resection was 99.1% (466/470). Additional gastrectomy was conducted in 131 patients (28%) who did not fulfill the curative resection criteria. The 5-year OS of all patients was 97.0% (95% confidence interval, 95.0-98.2%), which was higher than the threshold 5-year OS (86.1%). The 317 patients who satisfied the curative resection criteria had no recurrence. There were no ESD-related grade 4 adverse events.

CONCLUSION:

ESD for early gastric cancers that met the expanded criteria for intestinal-type gastric cancer (cT1a) was acceptable and should be the standard treatment instead of gastrectomy.

KEYWORDS:

Endoscopic submucosal resection; Endoscopy; Gastrectomy; Stomach neoplasms

PMID:
28224238
DOI:
10.1007/s10120-017-0704-y
[Indexed for MEDLINE]

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