ArticleDrugs - real world outcomes2022
Adverse Drug Reactions with HER2-Positive Breast Cancer Treatment: An Analysis from the Italian Pharmacovigilance Database.
Article in Drugs - real world outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed, 32 citations in OpenAlex.
- Recurrent severe thrombocytopenia induced by anti-HER2 therapy in a breast cancer patient with an underlying immune disorder: a case report and literature review.Frontiers in oncology · 2026Article
- Signal mining and safety profile analysis of lapatinib: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.Journal of pharmaceutical policy and practice · 2026Article
- Cardiotoxicity in low-to-moderate cardiovascular risk patients undergoing anti-HER2 therapy: a prospective cardiac magnetic resonance study.Radiology and oncology · 2025Article
- Real-world pharmacovigilance assessment of hepatotoxicity risk with HER2-Targeted drugs using FAERS database analysis.Scientific reports · 2025Article
- Effects of Anticancer Therapy on Osteoporosis in Breast Cancer Patients: A Nationwide Study Using Data from the National Health Insurance Service-National Health Information Database.Journal of clinical medicine · 2025Article
- Pembrolizumab-Associated Cardiotoxicity: A Retrospective Analysis of the FDA Adverse Events Reporting System.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Clinical characteristics and influencing factors of anti-PD-1/PD-L1-related severe cardiac adverse event: based on FAERS and TCGA databases.Scientific reports · 2024Article
- Neuropsychiatric Adverse Events with Monoclonal Antibodies Approved for Multiple Myeloma: An Analysis from the FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Long-term hepatobiliary disorder associated with trastuzumab emtansine pharmacovigilance study using the FDA Adverse Event Reporting System database.Scientific reports · 2024Article
- Article
- Prevention of Anthracyclines and HER2 Inhibitor-Induced Cardiotoxicity: A Systematic Review and Meta-Analysis.Cancers · 2024Review
- Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Thromboembolic Events Associated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System (FAERS) Database.Clinical drug investigation · 2024Review
- Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Article
- A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS).BMC pharmacology & toxicology · 2023Article
- Renal Disorders with Oral Tyrosine Kinase Inhibitors in Metastatic Colorectal Cancer: An Analysis from the FDA Adverse Event Reporting System Database.Biomedicines · 2023Article
- Article
- Cardiotoxicity from neoadjuvant targeted treatment for breast cancer prior to surgery.Frontiers in cardiovascular medicine · 2023Review
- Neuropsychiatric adverse drug reactions with oral tyrosine kinase inhibitors in metastatic colorectal cancer: an analysis from the FDA Adverse Event Reporting System.Frontiers in oncology · 2023Article
- Effectiveness and Safety Profiles of Biological Therapies in Inflammatory Bowel Disease: Real Life Data from an Active Pharmacovigilance Project.Biomedicines · 2022Article
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnti-HER2 therapy has evolved in the last years and an important role in this transformation was that of monoclonal antibodies and tyrosine kinase inhibitors. Considering their extended use in clinical practice, some toxicity problems have been highlighted around these drugs.
objectiveTo analyze the onset of adverse drug reactions (ADRs) related to the use of HER2-positive breast cancer treatments through a spontaneous reporting system (SRS) database.
methodsAll ADR reports having as suspected drug trastuzumab, pertuzumab, lapatinib, or trastuzumab emtansine (TDM-1), recorded into the Report Reazioni Avverse dei Medicinali (RAM) system database for national data and into the Italian SRS database for Sicilian data and collected from 2006 to 2020 have been evaluated. A descriptive analysis of basal demographic and drug-related characteristics was performed. A case-by-case methodology was conducted paying particular attention to the serious ADR reports collected in Sicily, focusing on type of seriousness, age, sex, concomitant drugs, comorbidities, time to onset (TTO), and time to resolution (TTR).
resultsOf the 3609 Italian reports, 65.6% were related to trastuzumab (n = 2367), followed by pertuzumab, TDM-1, and lapatinib. Almost all reports occurred in female patients (94.3%) and were most frequent in the age group 18-65 years (69.6%). A higher number of cases were related to general disorders and administration site conditions (n = 1079; 29.9%), gastrointestinal disorders (n = 1037; 28.7%), skin disorders (n = 821; 22.7%), and blood disorders (n = 599; 16.6%). Cases involving trastuzumab and pertuzumab mainly reported general disorders (n = 788; 33.3% and n = 194; 32.1%, respectively) while more than half of the reports associated with lapatinib were related to gastrointestinal (n = 184; 59.7%) and skin diseases (n = 146; 47.4%). Regarding TDM-1, 40% of reports had at least one ADR belonging to blood and lymphatic system disorders. The case-by-case assessment of Sicilian ADR reports showed that 40 cases were serious (33.3%), with a median TTO of 37 (6-97) days. Serious ADR reports mainly involved the onset of thrombocytopenia (n = 8; 20.0%), diarrhea (n = 6; 15.0%), asthenia and cardiac failure (both with n = 5; 12.5%), vomiting, hypersensitivity, and ejection fraction decreased (all with n = 4; 10.0%) and stomatitis (n = 3: 7.5%).
conclusionThis study is fundamentally consistent with results from the literature. Given the serious clinical condition of breast cancer and taking into account the importance of preventing some clinically relevant ADRs related to the use of anti-HER2 therapy, further analyses are essential to better describe the safety profile of these target therapies.
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