Evidence map›Paper›PMID 39373732›Full record

ArticleArchives of gynecology and obstetrics2025

Impact of low HER2 expression on response to CDK4/6 inhibitor treatment in advanced HR + /HER2- breast cancer: a multicenter real-world data analysis.

Damian J Ralser, Verena Kiver, Erich-Franz Solomayer, Caroline Neeb, Jens-Uwe Blohmer, Alina V Abramian, Nicolai Maass, Florian Schütz, Cornelia Kolberg-Liedtke, Carolin Müller and 1 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Archives of gynecology and obstetrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
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

11 authors.

Damian J Ralser *Department of Gynecology and Gynecological Oncology, University Hospital Bonn, University Medical Center Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. damian.ralser@ukbonn.de.
Verena Kiver *Department of Gynecology With Breast Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Erich-Franz SolomayerDepartment of Gynecology, Obstetrics & Reproductive Medicine, Saarland University Medical Center, Homburg, Saar, Germany.
Caroline NeebDepartment of Gynecology With Breast Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Jens-Uwe BlohmerDepartment of Gynecology With Breast Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Alina V AbramianDepartment of Gynecology and Gynecological Oncology, University Hospital Bonn, University Medical Center Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.
Nicolai MaassDepartment of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
Florian SchützDepartment of Gynecology and Obstetrics, Diakonissen-Stiftungs-Krankenhaus Speyer, Speyer, Germany.
Cornelia Kolberg-LiedtkeDepartment of Gynecology and Obstetrics, University Medical Center, Essen, Germany.
Carolin Müller *Department of Gynecology, Obstetrics & Reproductive Medicine, Saarland University Medical Center, Homburg, Saar, Germany.
Anna-Christina Rambow *Department of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.

Funding

BONFOR 2021-1A-14DFG grant ID 413490537DFG grant ID MU 4812/2-1:2
6 · The paper itself

Abstract

purposeCDK4/6 inhibitors (CDK4/6i) represent the first-line therapy approach of choice for patients with hormone receptor-positive, HER2-negative advanced breast cancer (HR + /HER-ABC). Approximately 50% of HR + /HER2-ABC displays low HER2 expression (HER2 low). Recent data emerging from the DESTINY-Breast04 trial demonstrated practice-changing efficacy of the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) in patients with low HER2 expression. Here, we aimed to analyze the impact of low HER2 expression on CDK4/6i therapy response in a well-characterized multicenter HR + /HER-ABC cohort.

methodsPatients diagnosed with HR + /HER2-ABC who were treated with CDK4/6i in clinical routine between November 2016 and December 2020 at four certified German Breast Cancer Centers were retrospectively identified. The cohort was stratified according to graduation of positivity in HER2 immunohistochemistry (IHC; HER2 zero = IHC score 0 and HER2 low = IHC score 1 + , 2 + /fluorescence in situ hybridization negative). Subgroups were analyzed with regard to progression-free survival (PFS) following CDK4/6i initiation.

findingsThe study cohort comprised n = 448 patients. For n = 311 patients, HER2 status from the metastatic site was available. n = 91 (29.3%) cases were HER2 zero and n = 220 cases (70.7%) were HER2 low. There was no significant difference in PFS between the two groups (PFS: 17 months versus 18 months, log-rank p = 0.42). Further, we examined the influence of HER2 expression changes between primary and metastatic tissue (n = 171; HER2 gain/HER2 loss/HER2 stable expression) on CDK4/6i treatment response. Again, there was no significant difference between these three groups, respectively (PFS: 16 months versus 13 months versus 17 months, log-rank p = 0.86).

conclusionsIn our analysis, HER2 status did not have a significant impact on treatment response to CDK4/6i.

Indexed as

Breast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsAdultAgedAged, 80 and overCamptothecinFemaleHumansImmunoconjugatesMiddle AgedReceptors, EstrogenRetrospective StudiesTrastuzumabCamptothecinCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesProtein Kinase InhibitorsReceptors, EstrogenTrastuzumabtrastuzumab deruxtecanBreast cancerCDK4/6 inhibitorHER2 lowTrastuzumab deruxtecan

Identifiers

PMID39373732
PMCPMC11890318

What OpenQuestion holds

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Registered trials

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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.