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Peer-reviewedCC BY 4.0Esophagus

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

  • Kazuhiro Shiraishi1
  • Ken Kato1
  • Yuya Ishikawa2
  • Keita Sasaki2
  • Hiroyuki Daiko3
  • Yoshinori Ito4
  • Takeshi Kajiwara5
  • Takashi Kojima6
  • Hiroshi Miyata7
  • Masaki Ueno8
  • Satoru Nakagawa9
  • Shinsuke Sato10
8 more authors
  • Shigeru Tsunoda11
  • Tetsuya Abe12
  • Yoshiaki Nagatani13
  • Yoichi Hamai14
  • Yasue Kimura15
  • Kenro Hirata16
  • Takahiro Tsushima17
  • Hiroya Takeuchi18
18 affiliations
  1. 1Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
  2. 2JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo City, Japan
  3. 3Department of Esophageal Surgery, National Cancer Center Hospital, Chuo City, Japan
  4. 4Department of Radiation Oncology, Showa Medical University School of Medicine, Tokyo, Japan
  5. 5Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
  6. 6Division of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan
  7. 7Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan
  8. 8Department of Gastroenterological Surgery, Toranomon Hospital, Minato, Japan
  9. 9Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan
  10. 10Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan
  11. 11Department of Surgery, Kyoto University, Kyoto, Japan
  12. 12Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan
  13. 13Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan
  14. 14Department of Surgical Oncology, Hiroshima University, Higashihiroshima, Japan
  15. 15Department of Gastrointestinal Surgery, NHO Kyushu Cancer Center, Fukuoka, Japan
  16. 16Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
  17. 17Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan
  18. 18Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10388-026-01244-w.

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Cite

BibTeXRIS
BibTeX
@article{shiraishi2026institutional,
  title = {{Institutional enrollment volume and clinical outcomes after surgery or chemoradiotherapy for clinical stage I esophageal squamous cell carcinoma: a supplementary analysis of JCOG0502}},
  author = {Kazuhiro Shiraishi and Ken Kato and Yuya Ishikawa and Keita Sasaki and Hiroyuki Daiko and Yoshinori Ito and Takeshi Kajiwara and Takashi Kojima and Hiroshi Miyata and Masaki Ueno and Satoru Nakagawa and Shinsuke Sato and Shigeru Tsunoda and Tetsuya Abe and Yoshiaki Nagatani and Yoichi Hamai and Yasue Kimura and Kenro Hirata and Takahiro Tsushima and Hiroya Takeuchi},
  journal = {Esophagus},
  year = {2026},
  month = aug,
  doi = {10.1007/s10388-026-01244-w},
  url = {https://doi.org/10.1007/s10388-026-01244-w},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Institutional enrollment volume and clinical outcomes after surgery or chemoradiotherapy for clinical stage I esophageal squamous cell carcinoma: a supplementary analysis of JCOG0502
AU  - Kazuhiro Shiraishi
AU  - Ken Kato
AU  - Yuya Ishikawa
AU  - Keita Sasaki
AU  - Hiroyuki Daiko
AU  - Yoshinori Ito
AU  - Takeshi Kajiwara
AU  - Takashi Kojima
AU  - Hiroshi Miyata
AU  - Masaki Ueno
AU  - Satoru Nakagawa
AU  - Shinsuke Sato
AU  - Shigeru Tsunoda
AU  - Tetsuya Abe
AU  - Yoshiaki Nagatani
AU  - Yoichi Hamai
AU  - Yasue Kimura
AU  - Kenro Hirata
AU  - Takahiro Tsushima
AU  - Hiroya Takeuchi
PY  - 2026
DA  - 2026/08/27
JO  - Esophagus
DO  - 10.1007/s10388-026-01244-w
UR  - https://doi.org/10.1007/s10388-026-01244-w
AB  - Background: 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.  Methods: 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.  Results: 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.  Conclusions: 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.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10388-026-01244-w.
SN  - 1612-9059
SN  - 1612-9067
ER  -