94% of researchers rate our articles as excellent or good
Learn more about the work of our research integrity team to safeguard the quality of each article we publish.
Find out more
ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1538881
This article is part of the Research Topic Advances in Drug-induced Diseases Volume II View all 41 articles
Signal Detection and Safety Analysis of Three Tyrosine Kinase Inhibitors for HER-2 Positive Breast Cancer: A Retrospective Study Based on the FAERS Database
Provisionally accepted- 1 People’s Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding, China
- 2 Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China
- 3 Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
- 4 Department of Pharmacology, Faculty of Medicine and Nursing. University of the Basque Country, Leioa, Basque Country, Spain
Objective:To identify adverse event (ADE) signals of three tyrosine kinase inhibitors (TKIs) (Tucatinib, Lapatinib, and Neratinib) used for HER-2 positive breast cancer by utilizing the FAERS database, and to analyze their safety profiles to provide references for clinical risk management.Methods: Data from the FAERS database spanning Q1 2015 to Q3 2024 were retrieved, including reports where Tucatinib, Lapatinib, or Neratinib was identified as the primary suspect drug. Disproportionality analysis (ROR, PRR) and the Comprehensive Standard method were employed to detect potential ADE signals. The distribution of ADEs across different System Organ Classifications (SOCs) was also analyzed.Results: A total of 7,848 ADE reports were analyzed, identifying 557 significant signals. The primary ADEs were concentrated in gastrointestinal disorders, general conditions, administration site reactions, and skin and subcutaneous tissue disorders. Neratinib exhibited higher gastrointestinal toxicity, Lapatinib was associated with notable skin toxicities, and Tucatinib showed specific adverse reactions linked to combination therapies.Conclusion: The three TKIs demonstrated distinct ADE signal profiles, with gastrointestinal, systemic, and skin toxicities being the major areas of concern. Future research should validate these findings and develop effective management strategies to enhance treatment safety and improve the quality of life for HER-2 positive breast cancer patients.
Keywords: FAERS database, Tyrosine kinase inhibitors (TKIs), HER-2 positive breast cancer, Adverse event signals, Safety analysis, disproportionality analysis (ROR, PRR)
Received: 03 Dec 2024; Accepted: 13 Feb 2025.
Copyright: © 2025 Tang, Wang, Li, Tang, Zhang and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
ChengLiang Wang, People’s Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding, China
Li Chen, Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.