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2026年8月28日星期五
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机构入组量对临床I期食管鳞状细胞癌手术或放化疗后临床结局的影响：JCOG0502的补充分析

Institutional enrollment volume and clinical outcomes after surgery or chemoradiotherapy for clinical stage I esophageal squamous cell carcinoma: a supplementary analysis of JCOG0502.

期刊
Esophagus
PMID
42658443
原文
PubMed ↗
发布日期

作者

  • Kazuhiro Shiraishi — Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Ken Kato — Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kenkato@ncc.go.jp.
  • Yuya Ishikawa — JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo City, Japan.
  • Keita Sasaki — JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo City, Japan.
  • Hiroyuki Daiko — Department of Esophageal Surgery, National Cancer Center Hospital, Chuo City, Japan.
  • Yoshinori Ito — Department of Radiation Oncology, Showa Medical University School of Medicine, Tokyo, Japan.
  • Takeshi Kajiwara — Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
  • Takashi Kojima — Division of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Hiroshi Miyata — Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
  • Masaki Ueno — Department of Gastroenterological Surgery, Toranomon Hospital, Minato, Japan.
  • Satoru Nakagawa — Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
  • Shinsuke Sato — Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
  • Shigeru Tsunoda — Department of Surgery, Kyoto University, Kyoto, Japan.
  • Tetsuya Abe — Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
  • Yoshiaki Nagatani — Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
  • Yoichi Hamai — Department of Surgical Oncology, Hiroshima University, Higashihiroshima, Japan.
  • Yasue Kimura — Department of Gastrointestinal Surgery, NHO Kyushu Cancer Center, Fukuoka, Japan.
  • Kenro Hirata — Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
  • Takahiro Tsushima — Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Hiroya Takeuchi — Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.

作者单位

  • Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
  • Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kenkato@ncc.go.jp.
  • JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo City, Japan.
  • Department of Esophageal Surgery, National Cancer Center Hospital, Chuo City, Japan.
  • Department of Radiation Oncology, Showa Medical University School of Medicine, Tokyo, Japan.
  • Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
  • Division of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
  • Department of Gastroenterological Surgery, Toranomon Hospital, Minato, Japan.
  • Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
  • Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
  • Department of Surgery, Kyoto University, Kyoto, Japan.
  • Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
  • Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
  • Department of Surgical Oncology, Hiroshima University, Higashihiroshima, Japan.
  • Department of Gastrointestinal Surgery, NHO Kyushu Cancer Center, Fukuoka, Japan.
  • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
  • Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.

摘要

中文

手术和放化疗（CRT）是临床I期食管鳞状细胞癌（ESCC）的标准治疗选择。JCOG0502是一项多中心、非随机、平行组比较研究，证明了根治性CRT在cT1bN0M0 ESCC患者的总生存期（OS）方面非劣于手术；然而，机构差异可能影响结局。本研究探讨了JCOG0502患者中生存率和不良事件（AEs）的机构间异质性。在379例入组患者中，364例被分析。入组≥13例患者的机构（对应于机构试验入组的中位数）被归类为高入组机构（High），而入组<13例的机构被归类为低入组机构（Low）。机构试验入组量被评估为探索性指标，而非机构病例量或手术量的直接衡量。主要终点是OS。次要终点是无进展生存期（PFS）和AEs。在手术组中，机构试验入组量与OS无显著关联（High与Low的HR为0.73；95% CI，0.40-1.35）。类似地，在CRT组中未观察到显著关联（HR，1.12；95% CI，0.59-2.13）。PFS的结果与两组中的这些OS结果一致。心肌缺血或梗死发生在CRT组的5例Low患者中，High中没有。在手术组或CRT组中，机构试验入组量与生存结局之间未发现明确关联。然而，不能排除临床上意义的差异。观察到的某些毒性（包括心肌缺血）的差异应被视为假设产生性的。

English

Surgery and chemoradiotherapy (CRT) are standard options for clinical stage I esophageal squamous cell carcinoma (ESCC). JCOG0502, a multicenter, non-randomized, parallel-group comparison, demonstrated the non-inferiority of definitive CRT compared with surgery for overall survival (OS) in patients with cT1bN0M0 ESCC; however, institutional differences may influence outcomes. This study explored inter-institutional heterogeneity in survival and adverse events (AEs) among patients in JCOG0502. Among 379 enrolled patients, 364 were analyzed. Institutions enrolling ≥ 13 patients, corresponding to the median institutional trial enrollment, were classified as high-enrollment institutions (High), whereas those enrolling < 13 patients were classified as low-enrollment institutions (Low). Institutional trial enrollment was evaluated as an exploratory indicator, rather than as a direct measure of institutional case or procedural volume. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS) and AEs. In the surgery group, institutional trial enrollment volume was not significantly associated with OS (HR for High vs. Low, 0.73; 95% CI, 0.40-1.35). Similarly, no significant association was observed in the CRT group (HR, 1.12; 95% CI, 0.59-2.13). Findings for PFS were consistent with these OS results in both groups. Myocardial ischemia or infarction occurred in 5 patients in Low and none in High in the CRT group. No clear association was identified between institutional trial enrollment volume and survival outcomes in either the surgery or CRT group. However, clinically meaningful differences could not be excluded. The observed differences in selected toxicities, including myocardial ischemia, should be considered hypothesis-generating.

分类与指标

研究类型
临床研究
病种
食管癌
JCR 分区
Q1
影响因子
5.8
新锐分区
4区