Evidence map›Paper›PMID 31087075›Full record

Trial reportJapanese journal of clinical oncology2019

Comparison of Claudin 18.2 expression in primary tumors and lymph node metastases in Japanese patients with gastric adenocarcinoma.

Christoph Rohde, Rin Yamaguchi, Svetlana Mukhina, Ugur Sahin, Kyogo Itoh, Özlem Türeci

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Japanese journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01630083 (A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX), which is not on this map. Cited by 103 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 3 pooled it
6.8field-weighted citation impact, top 2% 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.

NCT01630083 phase2completednot on this map

A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2012 to 2019Enrolled252ConditionsCLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Gastric AdenocarcinomaArmsepirubicin, oxaliplatin, capecitabine, zolbetuximab
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 3 syntheses or guidelines pooled it, 137 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. The Significance of theFrontiers in oncology · 2020
    Pooled it
  4. Trial
  5. SPOTlight on GLOW.Cell reports. Medicine · 2023
    Trial
  6. Trial
  7. Review
  8. Article
  9. Claudin 18.2 Targeting: A Pan-Cancer Perspective.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article

43 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

6 authors at 4 institutions in 2 countries.

Christoph RohdeFormerly of Ganymed Pharmaceuticals GmbH, Mainz, Germany.
Rin YamaguchiDepartment of Pathology and Clinical Medicine, Kurume University Medical Center, Kurume, Fukuoka, Japan.
Svetlana MukhinaFormerly of Ganymed Pharmaceuticals GmbH, Mainz, Germany.
Ugur SahinTRON, Translational Oncology at the University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
Kyogo ItohKurume University Cancer Vaccine Center, Kurume, Fukuoka, Japan.
Özlem TüreciCi3-Cluster of Individualized Immune Intervention, Mainz, Germany.
MerLion Pharma (Germany) · DEJohannes Gutenberg University Mainz · DEKurume University · JPKurume University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe monoclonal antibody zolbetuximab (formerly IMAB362), which is being developed as a potential treatment for gastric cancer (GC), targets Claudin 18.2 (CLDN18.2), a GC biomarker. This study aimed to determine the prevalence of CLDN18.2 in primary tumors and lymph node (LN) metastases of Japanese patients with GC.

methodsCLDN18.2 expression was investigated in tissue samples from patients with gastric adenocarcinoma archived at Kurume University Medical Center, Japan, between 2000 and 2012. Expression of CLDN18.2 in tumor samples was evaluated by immunohistochemistry using the same detection antibody (43-14A) and assay used in the FAST clinical trial (NCT01630083), a phase 2 randomized trial that compared the safety and antitumor activity of the zolbetuximab-chemotherapy combination with chemotherapy alone. Samples showing any specific staining with ≥1+ intensity were defined as CLDN18.2-positive.

resultsOf 263 samples analyzed (134 primary gastric tumors and corresponding LN metastases; 128 primary tumors only; one LN metastases only), CLDN18.2 was detected in 87% (n = 228/262) of all primary tumors and 80% (n = 108/135) of LN metastases. Moderate-to-strong CLDN18.2 expression (≥2+ membrane staining intensity in ≥40% of tumor cells [FAST eligibility criterion]) was observed in 52% (n = 135/262) of primary tumors and 45% (n = 61/135) of (LN) metastases. CLDN18.2 expression was significantly higher in GCs of the diffuse histological subtype per Lauren classification and in high grade (G3) tumors.

conclusionsThe high prevalence of CLDN18.2 among Japanese patients with GC supports the therapeutic assessment of zolbetuximab in this population.

Indexed as

Gene Expression Regulation, NeoplasticAdenocarcinomaAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleClaudinsHumansImmunohistochemistryLymphatic MetastasisStomach NeoplasmsAntibodies, MonoclonalClaudinsCLDN18 protein, humanzolbetuximabbiomarkersClaudingastric cancerimmunohistochemistryprevalence

Identifiers

PMID31087075
PMCPMC6792344
OpenAlexW2946770750

What OpenQuestion holds

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Registered trials

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.