Evidence map›Paper›PMID 38790915›Full record

ArticleBiomedicines2024

Safety Profile of the Trastuzumab-Based ADCs: Analysis of Real-World Data Registered in EudraVigilance.

Claudiu Morgovan, Carmen Maximiliana Dobrea, Anca Butuca, Anca Maria Arseniu, Adina Frum, Luca Liviu Rus, Adriana Aurelia Chis, Anca Maria Juncan, Felicia Gabriela Gligor, Cecilia Georgescu and 2 more

Abstract read
In one paragraph

Article in Biomedicines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Antibody-Drug Conjugates-Evolution and Perspectives.International journal of molecular sciences · 2024
    Review
  14. Article
  15. 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

12 authors.

Claudiu MorgovanPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-2730-8729
Carmen Maximiliana DobreaPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-9913-1750
Anca ButucaPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-1540-641X
Anca Maria ArseniuPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Adina FrumPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-4874-0430
Luca Liviu RusPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-3622-2815
Adriana Aurelia ChisPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-3128-2763
Anca Maria JuncanPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-5064-0239
Felicia Gabriela GligorPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-3167-9864
Cecilia GeorgescuFaculty of Agriculture Science, Food Industry and Environmental Protection, "Lucian Blaga" University of Sibiu, 550012 Sibiu, Romania.ORCID 0000-0003-4804-1138
Steliana GhibuDepartment of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.ORCID 0000-0003-2247-4613
Andreea Loredana Vonica-TincuPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0001-6362-4302

Funding

Lucian Blaga University of Sibiu LBUS-IRG-2023/No. 3549, 24 July 2023
6 · The paper itself

Abstract

Trastuzumab (T) and tyrosine kinase inhibitors (TKIs) are among the first-line treatments recommended for HER2-positive breast cancer. More recently, antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1) have been authorized, and they represent the second-line therapy in this type of cancer. The present study aimed to evaluate adverse drug reactions (ADRs) associated with T-based ADCs that were spontaneously reported in EudraVigilance-the European pharmacovigilance database. Out of 42,272 ADRs reported for currently approved ADCs on the market, 24% of ADRs were related to T-DM1, while 12% of ADRs were related to T-DXd. T-DM1 had a higher probability of reporting eye, ear and labyrinth, and cardiac and hepatobiliary ADRs, while T-DXd had a higher probability of reporting respiratory, thoracic and mediastinal, blood and lymphatic system, metabolism and nutrition, and gastrointestinal ADRs. The present research found that in terms of hematological disorders, T-DM1 and T-DXd had a higher probability of reporting ADRs than TKIs. Moreover, the data showed that T-DM1 seemed to have a higher risk of cardiotoxicity than T-DXd, while T-DXd had a higher probability of reporting metabolism and nutrition disorders than T-DM1.

Indexed as

adverse reactionsantibody-drug conjugatesdescriptive analysisdisproportionality analysisEudraVigilanceHER2-positive breast cancerHER2-targeted therapypharmacovigilancetrastuzumab deruxtecantrastuzumab emtansine

Identifiers

PMID38790915
PMCPMC11117560

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.