Clinical Impact of Trastuzumab Deruxtecan in Patients With HER2-Positive Advanced Gastric Cancer and Ascites: Findings From the EN-DEAVOR Study.
17 affiliations
- 1Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
- 2Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
- 3Department of Clinical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
- 4Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
- 5Cancer Center, Gifu University Hospital, Gifu, Japan.
- 6Department of Genetic Oncology, Osaka International Cancer Institute, Osaka, Japan.
- 7Division of Digestive Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
- 8Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
- 9Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
- 10Department of Surgery, Kindai University Faculty of Medicine, Sakai, Japan.
- 11Department of Gastrointestinal Medical Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
- 12Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
- 13Department of Surgery, Nihonkai General Hospital, Sakata, Japan.
- 14NHO Nagoya Medical Center, Nagoya, Japan.
- 15Oncology Medical Science Department I, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
- 16Data Intelligence Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
- 17Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. [email protected].
Abstract
Purpose
Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) and ascites have poor prognosis and are often excluded from clinical trials. Thus, evidence on the effect of trastuzumab deruxtecan (T-DXd) in this population remains limited.Materials and methods
This subgroup analysis of the EN-DEAVOR (UMIN000049032) study assessed outcomes in patients with T-DXd-treated HER2-positive AGC from Japan, stratified by computed tomography-defined ascites severity: none (ascites not detected), low (confined to the upper or lower abdomen), moderate (neither low nor high), and high (diffusely present throughout the abdomen). The outcomes included overall survival (OS), real-world progression-free survival (rwPFS), ascites response rate, and incidence of grade ≥3 adverse events (AEs).Results
Among 312 patients, 173, 81, 34, and 20 had no, low, moderate, and high ascites severity, respectively. The median OS was 12.35, 6.77, 6.97, and 5.13 months, respectively, and the median rwPFS was 5.32, 3.68, 3.50, and 2.76 months, respectively, for the no, low, moderate, and high severity groups. The overall ascites response rate to ascites severity was 23.0%. The median OS and rwPFS were 11.83 (95% confidence interval [CI], 7.82-18.96) and 6.64 (95% CI, 4.17-9.56) months, respectively, in responders, and 6.28 (95% CI, 4.90-7.03) and 3.15 (95% CI, 2.17-3.94) months, respectively, in non-responders. Grade ≥3 AE incidence was comparable across subgroups.Conclusions
T-DXd demonstrated efficacy and a manageable safety profile in patients with HER2-positive AGC, including those with severe ascites. The ascites response correlated with improved outcomes.
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BibTeX
@article{minashi2026clinical,
title = {{Clinical Impact of Trastuzumab Deruxtecan in Patients With HER2-Positive Advanced Gastric Cancer and Ascites: Findings From the EN-DEAVOR Study.}},
author = {Keiko Minashi and Rin Inamoto and Hisato Kawakami and Koki Nakanishi and Akitaka Makiyama and Naotoshi Sugimoto and Hirotaka Konishi and Satoshi Morita and Yukiya Narita and Motohiro Imano and Tomohiro Nishina and Takeshi Kawakami and Motohisa Hagiwara and Yasuhiro Kodera and Hiroki Kume and Keita Yamaguchi and Wataru Hashimoto and Kei Muro},
journal = {Journal of gastric cancer},
year = {2026},
month = oct,
doi = {10.5230/jgc.2026.26.e42},
url = {https://europepmc.org/article/MED/42845253},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Clinical Impact of Trastuzumab Deruxtecan in Patients With HER2-Positive Advanced Gastric Cancer and Ascites: Findings From the EN-DEAVOR Study.
AU - Keiko Minashi
AU - Rin Inamoto
AU - Hisato Kawakami
AU - Koki Nakanishi
AU - Akitaka Makiyama
AU - Naotoshi Sugimoto
AU - Hirotaka Konishi
AU - Satoshi Morita
AU - Yukiya Narita
AU - Motohiro Imano
AU - Tomohiro Nishina
AU - Takeshi Kawakami
AU - Motohisa Hagiwara
AU - Yasuhiro Kodera
AU - Hiroki Kume
AU - Keita Yamaguchi
AU - Wataru Hashimoto
AU - Kei Muro
PY - 2026
DA - 2026/10/01
JO - Journal of gastric cancer
DO - 10.5230/jgc.2026.26.e42
UR - https://europepmc.org/article/MED/42845253
AB - Purpose Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) and ascites have poor prognosis and are often excluded from clinical trials. Thus, evidence on the effect of trastuzumab deruxtecan (T-DXd) in this population remains limited.Materials and methods This subgroup analysis of the EN-DEAVOR (UMIN000049032) study assessed outcomes in patients with T-DXd-treated HER2-positive AGC from Japan, stratified by computed tomography-defined ascites severity: none (ascites not detected), low (confined to the upper or lower abdomen), moderate (neither low nor high), and high (diffusely present throughout the abdomen). The outcomes included overall survival (OS), real-world progression-free survival (rwPFS), ascites response rate, and incidence of grade ≥3 adverse events (AEs).Results Among 312 patients, 173, 81, 34, and 20 had no, low, moderate, and high ascites severity, respectively. The median OS was 12.35, 6.77, 6.97, and 5.13 months, respectively, and the median rwPFS was 5.32, 3.68, 3.50, and 2.76 months, respectively, for the no, low, moderate, and high severity groups. The overall ascites response rate to ascites severity was 23.0%. The median OS and rwPFS were 11.83 (95% confidence interval [CI], 7.82-18.96) and 6.64 (95% CI, 4.17-9.56) months, respectively, in responders, and 6.28 (95% CI, 4.90-7.03) and 3.15 (95% CI, 2.17-3.94) months, respectively, in non-responders. Grade ≥3 AE incidence was comparable across subgroups.Conclusions T-DXd demonstrated efficacy and a manageable safety profile in patients with HER2-positive AGC, including those with severe ascites. The ascites response correlated with improved outcomes.
SN - 2093-582X
SN - 2093-5641
ER -