Evidence map›Paper›PMID 38802399›Full record

ArticleScientific reports2024

HER2 quantitative continuous scoring for accurate patient selection in HER2 negative trastuzumab deruxtecan treated breast cancer.

Ansh Kapil, Andreas Spitzmüller, Nicolas Brieu, Susanne Haneder, Anatoliy Shumilov, Armin Meier, Fabiola Cecchi, Alice Barkell, Nathalie Harder, Katrin Mittermaier and 10 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02564900 (Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

NCT02564900 phase1completednot on this map

Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2015 to 2023Enrolled292ConditionsAdvanced Solid TumorsArmsDS-8201a (DP1), DS-8201a (DP2), DS-8201a (DP)
3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

  1. A modular framework for antibody-drug conjugate biomarkers.Nature reviews. Clinical oncology · 2026
    Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Quantitative Assays for TROP2 Measurement in Breast Cancer and Comparison to H-Score.Applied immunohistochemistry & molecular morphology : AIMM · 2026
    Article
  9. Review
  10. Predictive Biomarkers of Antibody-Drug Conjugate Efficacy for Solid Tumors: Current Challenges and the Potential Role of Quantitative Proteomics.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  11. Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  12. Review
  13. Derivation of AZD5335, a Novel FRα-Targeted TOP1i-Loaded ADC, for the Treatment of FRα-Expressing Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
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

20 authors.

Ansh KapilComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany. ansh.kapil@astrazeneca.com.ORCID 0000-0002-5079-6997
Andreas SpitzmüllerComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Nicolas BrieuComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Susanne HanederComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Anatoliy ShumilovComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Armin MeierComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Fabiola CecchiTranslational Medicine, Oncology R&D, AstraZeneca, Gaithersburg, MD, USA.
Alice BarkellTranslational Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.
Nathalie HarderComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Katrin MittermaierComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Ana Hidalgo-SastreComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Regina AllezeComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Markus SchickComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Günter SchmidtComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Hadassah SadeComputational Pathology, Oncology R&D, AstraZeneca, Bernhard-Wicki-Straße 5, 80636, München, Bayern, Germany.
Zenta TsuchihashiTranslational Science, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Fumitaka SutoTranslational Science, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Mark GustavsonTranslational Medicine, Oncology R&D, AstraZeneca, Gaithersburg, MD, USA.
J Carl BarrettTranslational Medicine, Oncology R&D, AstraZeneca, Gaithersburg, MD, USA.
Danielle CarrollTranslational Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many targeted cancer therapies rely on biomarkers assessed by scoring of immunohistochemically (IHC)-stained tissue, which is subjective, semiquantitative, and does not account for expression heterogeneity. We describe an image analysis-based method for quantitative continuous scoring (QCS) of digital whole-slide images acquired from baseline human epidermal growth factor receptor 2 (HER2) IHC-stained breast cancer tissue. Candidate signatures for patient stratification using QCS of HER2 expression on subcellular compartments were identified, addressing the spatial distribution of tumor cells and tumor-infiltrating lymphocytes. Using data from trastuzumab deruxtecan-treated patients with HER2-positive and HER2-negative breast cancer from a phase 1 study (NCT02564900; DS8201-A-J101; N = 151), QCS-based patient stratification showed longer progression-free survival (14.8 vs 8.6 months) with higher prevalence of patient selection (76.4 vs 56.9%) and a better cross-validated log-rank p value (0.026 vs 0.26) than manual scoring based on the American Society of Clinical Oncology / College of American Pathologists guidelines. QCS-based features enriched the HER2-negative subgroup by correctly predicting 20 of 26 responders.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesPatient SelectionTrastuzumabAdultAgedAntineoplastic Agents, ImmunologicalBiomarkers, TumorCamptothecinFemaleHumansImmunoconjugatesImmunohistochemistryMiddle AgedAntineoplastic Agents, ImmunologicalBiomarkers, TumorCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTrastuzumabtrastuzumab deruxtecan

Identifiers

PMID38802399
PMCPMC11130140

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.