Evidence map›Paper›PMID 36379002›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial.

Kensei Yamaguchi, Yung-Jue Bang, Satoru Iwasa, Naotoshi Sugimoto, Min-Hee Ryu, Daisuke Sakai, Hyun Cheol Chung, Hisato Kawakami, Hiroshi Yabusaki, Jeeyun Lee and 8 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 6 pooled it
15.4field-weighted citation impact, top 1% of its field
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

90 citing papers in PubMed, 6 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Pooled it
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  3. Guideline
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  6. Pooled it
  7. Trial
  8. Review
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  10. Antibody-Drug Conjugates in the Treatment of Esophageal Cancer.Current treatment options in oncology · 2026
    Review
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  12. Article
  13. Observational
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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 3 countries.

Kensei YamaguchiGastroenterological Chemotherapy Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0001-6887-5709
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.ORCID 0000-0001-6000-4597
Satoru IwasaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-3863-9582
Naotoshi SugimotoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, Seoul, South Korea.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Hospital, Osaka, Japan.ORCID 0000-0002-9436-7553
Hyun Cheol ChungDepartment of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.ORCID 0000-0002-0920-9471
Hisato KawakamiDepartment of Medical Oncology, Kindai University Hospital, Osaka, Japan.ORCID 0000-0002-3280-4850
Hiroshi YabusakiDepartment of Medical Oncology, Niigata Cancer Center Hospital, Niigata, Japan.
Jeeyun LeeDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea.ORCID 0000-0002-4911-6165
Tatsu ShimoyamaDepartment of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.ORCID 0000-0002-8491-703X
Kaku SaitoDaiichi Sankyo, Inc, Basking Ridge, NJ.
Yoshinori KawaguchiDaiichi Sankyo, Inc, Basking Ridge, NJ.
Takahiro KamioDaiichi Sankyo, Inc, Basking Ridge, NJ.
Akihito KojimaDaiichi Sankyo, Tokyo, Japan.
Masahiro SugiharaDaiichi Sankyo, Tokyo, Japan.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Daiichi Sankyo (United States) · USDaiichi-Sankyo (Japan) · JPNational Cancer Center Hospital East · JPAsan Medical Center · KRKindai University Hospital · JPNiigata Cancer Center Hospital · JPOsaka International Cancer Institute · JPOsaka University Hospital · JPSamsung Medical Center · KRSeoul National University · KRSeoul National University Bundang Hospital · KRThe Cancer Institute Hospital · JPTokyo Metropolitan Komagome Hospital · JPYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate efficacy and safety of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2 (HER2)-low gastric or gastroesophageal junction (GEJ) adenocarcinoma.

methodsPatients with locally advanced or metastatic HER2-low (cohort 1, immunohistochemistry 2+/in situ hybridization-negative; cohort 2, immunohistochemistry 1+) gastric/GEJ adenocarcinoma treated with at least two prior regimens, including fluoropyrimidine and platinum, but anti-HER2 therapy naive, received T-DXd 6.4 mg/kg intravenously once every 3 weeks. The primary end point was confirmed objective response rate by independent central review.

resultsAmong 21 patients enrolled in cohort 1 and 24 enrolled in cohort 2, 19 and 21 patients, respectively, had central HER2 confirmation, received T-DXd, and had measurable tumors at baseline. The confirmed objective response rate was 26.3% (95% CI, 9.1 to 51.2) from five partial responses in cohort 1 and 9.5% (95% CI, 1.2 to 30.4) from two partial responses in cohort 2. Thirteen patients (68.4%) in cohort 1 and 12 (60.0%) in cohort 2 experienced reduced tumor size. The median overall survival was 7.8 months (95% CI, 4.7 to nonevaluable) in cohort 1 and 8.5 months (95% CI, 4.3 to 10.9) in cohort 2; the median progression-free survival was 4.4 months (95% CI, 2.7 to 7.1) and 2.8 months (95% CI, 1.5 to 4.3), respectively. The most common grade ≥ 3 treatment-emergent adverse events in cohorts 1 and 2 were anemia (30.0% and 29.2%), decreased neutrophil count (25.0% and 29.2%), and decreased appetite (20.0% and 20.8%). Drug-related interstitial lung disease/pneumonitis occurred in one patient in each cohort (grade 1 or 2). No drug-related deaths occurred.

conclusionThis study provides preliminary evidence that T-DXd has clinical activity in patients with heavily pretreated HER2-low gastric/GEJ adenocarcinoma.

Indexed as

AdenocarcinomaStomach NeoplasmsAntibodies, Monoclonal, HumanizedCamptothecinErb-b2 Receptor Tyrosine KinasesEsophageal NeoplasmsEsophagogastric JunctionHumansImmunoconjugatesTrastuzumabAntibodies, Monoclonal, HumanizedCamptothecinErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID36379002
PMCPMC9901967
OpenAlexW4309164570

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.