Evidence map›Paper›PMID 39387986›Full record

ArticleGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2025

Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study).

Hisato Kawakami, Koki Nakanishi, Akitaka Makiyama, Hirotaka Konishi, Satoshi Morita, Yukiya Narita, Naotoshi Sugimoto, Keiko Minashi, Motohiro Imano, Rin Inamoto and 6 more

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Clinical impact of intratumoral HER2 heterogeneity on trastuzumab deruxtecan efficacy in patients with HER2-positive gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan. kawakami_h@med.kindai.ac.jp.ORCID 0000-0002-3280-4850
Koki NakanishiDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Akitaka MakiyamaCancer Center, Gifu University Hospital, Gifu, Japan.
Hirotaka KonishiDivision of Digestive Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Yukiya NaritaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Naotoshi SugimotoDepartment of Genetic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Keiko MinashiDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Motohiro ImanoDepartment of Surgery, Kindai University Faculty of Medicine, Osakasayama, Japan.
Rin InamotoDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Yasuhiro KoderaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hiroki KumeOncology Medical Science Department I, Daiichi Sankyo Co. Ltd., Tokyo, Japan.
Keita YamaguchiOncology Medical Science Department I, Daiichi Sankyo Co. Ltd., Tokyo, Japan.
Wataru HashimotoData Intelligence Department, Daiichi Sankyo Co. Ltd., Tokyo, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
EN-DEAVOR Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrastuzumab-deruxtecan (T-DXd) was approved for the treatment of HER2-positive patients with advanced gastric cancer in Japan based on the results of the DESTINY-Gastric01 trial. This study aimed to collect real-world data and evaluate the effectiveness and safety of T-DXd.

methodsPatients aged ≥ 20 years at the start of T-DXd administration with a histopathologically confirmed diagnosis of HER2-positive unresectable advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma that had worsened after chemotherapy were enrolled in this retrospective cohort study. Key outcomes included T-DXd treatment status, overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate and frequency of grade ≥ 3 adverse events (AEs).

resultsOf the 312 patients included in the analysis, 75.3% were male, the median (range) age was 70.0 (27.0-89.0) years, 12.2% had an ECOG PS ≥ 2, 43.3% had ascites and the initial T-DXd dose was > 5.4- ≤ 6.4 mg/kg in 78.2% of patients. The median (95% confidence interval) OS, rwPFS and TTF (months) was 8.9 (8.0-11.0), 4.6 (4.0-5.1) and 3.9 (3.4-4.2), respectively. The response rate was 42.9% in patients with a target lesion. In total, 48.4% of patients experienced a grade ≥ 3 AE, 2.6% experienced grade 5 AEs and 60.9% experienced AEs leading to T-DXd dose adjustments (reduction: 36.9%, interruption: 34.0% or discontinuation: 23.7%). No new safety signals were detected.

conclusionsT-DXd was effective and had a manageable safety profile as a third- or later-line treatment for patients with HER2-positive gastric or GEJ cancer in Japanese clinical practice. CLINICAL

trial registrationUMIN000049032.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesStomach NeoplasmsTrastuzumabAdenocarcinomaAdultAgedAged, 80 and overCamptothecinEast Asian PeopleFemaleHumansImmunoconjugatesJapanMaleMiddle AgedCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecanEffectivenessGastric cancerHER2-positiveJapanPost-marketing surveillanceReal worldSafetyThird- or later-lineTrastuzumab-deruxtecan (T-DXd)

Identifiers

PMID39387986
PMCPMC11706843

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.