Evidence map›Paper›PMID 42125714›Full record

ArticleFrontiers in oncology2026

Bridging practice and precision: a quantitative HER2 protein assay ready for clinical use in guiding trastuzumab deruxtecan therapy.

Junmei Hao, Xiaochun Fei, Fangfang Zou, Qian Hu, Linlin Du, Liya Yu, Xuanye Bai, Shasha Bi, Qinghua Cao, Weishan Chen and 22 more

Abstract read
In one paragraph

Article in Frontiers in 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

32 authors.

Junmei Hao *Department of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Xiaochun Fei *Department of Pathology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Fangfang ZouDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Qian HuDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Linlin DuDepartment of Pathology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Liya YuDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Xuanye BaiDepartment of Pathology, Henan Cancer Hospital, Zhengzhou, China.
Shasha BiDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Qinghua CaoDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Weishan ChenDepartment of Pathology, Quanzhou First Hospital, Quanzhou, China.
Qun DaiDepartment of Pathology, The Third People's Hospital of Hefei, Hefei Third Clinical College of Anhui Medical University, Hefei, China.
Tingting GuoDepartment of Pathology, The Fifth Affiliated Hospital of Xinjiang Medical University, Wulumuqi, China.
Hai HuangDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Wenwei JiangDepartment of Pathology, Autonomous Prefecture People's Hospital, Xiangxi, China.
Baohua LiDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Lixia LiDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Jingjing LiuYantai Zestern Biotechnique Co., LTD, A Division of Quanticision Diagnostics, Inc (US), Yantai, China.
Tong LiuDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Xiaoqin LiuDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Jiahong LyuYantai Zestern Biotechnique Co., LTD, A Division of Quanticision Diagnostics, Inc (US), Yantai, China.
Yue PanDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Xiaoqing ShaoDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Fangrong TangYantai Zestern Biotechnique Co., LTD, A Division of Quanticision Diagnostics, Inc (US), Yantai, China.
Tingting WangDepartment of Pathology, The People's Hospital of Lu'an, Lu'an, China.
Cuiping ZhangDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China.
Yongcun ZhuDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Job Tien Chiang LiuQuanticision Diagnostics, Inc., Chapel Hill, NC, United States.
Nicole SalazarL.Chambers Biomedical/Biotechnology Research Institute and Department of Biological & Biomedical Sciences, North Carolina Central University, Durham, NC, United States.
Shukun ZhangDepartment of Pathology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, China.
Jiandi ZhangQuanticision Diagnostics, Inc., Chapel Hill, NC, United States.
Xiaosong ChenDepartment of Breast Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Chaofu WangDepartment of Pathology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Current daily usage of Trastuzumab Deruxtecan (T-DXd) is guided by immunohistochemistry (IHC)-based HER2 assessment, with known inconsistency and inaccuracy to differentiating IHC 0 from 1 +. In this study, a quantitative HER2 assay based on the Quantitative Dot Blot (QDB) method was explored to fill this unmet need. Methods: Consecutive resection specimens of HER2 IHC 0 and 1+ from invasive breast cancer patients were assigned to training (n=106) and validation cohorts ( Results: QDB was demonstrated to be more consistent than IHC with an inter-rater Intraclass Correlation Coefficient (ICC) of 0.877 (95%CI: 0.840-0.908) vs. 0.513 (95%CI: 0.433-0.601). Receiver Operating Characteristic (ROC) analysis was performed benchmarked with unanimous agreement of 18 pathologists in the training cohort to achieve an Area Under the Curve (AUC) of 0.9477 (p<0.005). A cutoff of 0.2746 nmole/g was also identified with its imprecision interval to stratify specimens into 0 (<C Conclusion: Our results supports the QDB HER2 assay as an alternative option to guide T-DXd daily usage by distinguish Her2-low from Her2 0 while setting the stage for outcome-based patient stratification.

Indexed as

CDxErbB2HER2-lowQDBquantitativetrastuzumab deruxtecan

Identifiers

PMID42125714
PMCPMC13158065

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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.