Evidence map›Paper›PMID 42192045›Full record

Trial reportInternational journal of clinical oncology2026

Changes in plasma cfDNA ERBB2 copy number reflect prognosis in HER2-positive gastric cancer: a correlative analysis of the KSCC-TROX A2 study.

Yuki Shin, Akitaka Makiyama, Teppei Yamada, Tomomi Kashiwada, Masashi Hattori, Toshifumi Yamaguchi, Yoshiaki Shindo, Tetsuro Kawazoe, Sho Nambara, Yasuo Tsuda and 6 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Yuki ShinDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Akitaka MakiyamaCancer Center, Gifu University Hospital, Gifu, Japan.
Teppei YamadaDepartment of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Tomomi KashiwadaMedical Oncology, Saga-Ken Medical Centre Koseikan, Saga, Japan.
Masashi HattoriDepartment of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Toshifumi YamaguchiCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Yoshiaki ShindoNakadori General Hospital, Akita, Japan.
Tetsuro KawazoeDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Sho NambaraDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yasuo TsudaDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomonori NakanokoDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Koji AndoDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomoharu YoshizumiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kazuko SakaiDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka, Japan.
Kazuto NishioDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka, Japan.
Eiji OkiDepartment of Advanced Medicine and Innovative Technology, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. oki.eiji.857@m.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0002-9763-9366

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn HER2-positive advanced or recurrent gastric cancer, tissue-based HER2 assessment has been established; however, the clinical relevance of ERBB2 copy number (CN) measured from plasma cell-free DNA (cfDNA), particularly its longitudinal change during treatment, remains unclear.

methodsThis was a prespecified ancillary correlative analysis of the phase II KSCC-TROX trial (jRCTs071190007; UMIN000036867), evaluating whether changes in cfDNA ERBB2 CN (ΔCN) reflect clinical outcomes. Of the 66 patients included in the TROX trial analysis set, 55 with baseline blood samples comprised Cohort A, and 34 with paired follow-up samples comprised Cohort B. ERBB2 CN was quantified using droplet digital PCR.

resultsBaseline ERBB2 CN was associated with tumor HER2 immunohistochemistry score but not with progression-free survival (PFS) or overall survival (OS) when dichotomized at a cut-off of 2.5. In Cohort B, an increase in ERBB2 CN (ΔCN > 0) was significantly associated with shorter PFS compared with ΔCN ≤ 0 (p = 0.008), which was maintained in multivariable analysis (p = 0.001). OS was also significantly shorter in patients with ΔCN > 0 (p = 0.024).

conclusionsAn increase in cfDNA ERBB2 CN during treatment was independently associated with shorter PFS in HER2-positive advanced gastric cancer. Assessment of ERBB2 CN change may provide a useful biomarker for treatment monitoring and prognostic stratification.

Indexed as

Biomarkers, TumorCell-Free Nucleic AcidsDNA Copy Number VariationsErb-b2 Receptor Tyrosine KinasesStomach NeoplasmsAgedFemaleHumansMaleMiddle AgedPrognosisBiomarkers, TumorCell-Free Nucleic AcidsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesCell-free DNACopy numberDroplet digital PCRGastric cancerHER2/ERBB2

Identifiers

PMID42192045

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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.