ArticleFrontiers in oncology2023
Assessing real-world safety concerns of Sacituzumab govitecan: a disproportionality analysis using spontaneous reports in the FDA adverse event reporting system.
Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Pre-Therapeutic UGT1A1 Genotyping in Breast Cancer Patients Receiving Sacituzumab Govitecan to Improve Safety: A Meta-Analysis and Recommendation.Clinical and translational science · 2026Pooled it
- Dermatologic adverse events associated with Sacituzumab Govitecan: an international retrospective study from the EADV Task Force "Dermatology for Cancer Patients" and pharmacovigilance analysis.Breast cancer research and treatment · 2026Article
- Interstitial Lung Disease and Cardiotoxicity Associated with Trastuzumab Deruxtecan, Sacituzumab Govitecan, and Trastuzumab Emtansine: A Narrative Review.Medicina (Kaunas, Lithuania) · 2026Review
- Infectious Complications of Antibody-Drug Conjugates: A Review of Safety Data from FDA-Approved Agents.Current oncology reports · 2026Review
- Article
- Antibody-Drug Conjugates: Pharmacotherapeutic Properties and Future Perspectives.Pharmaceutics · 2026Review
- Ocular toxicity associated with antibody-drug conjugates in cancer therapy: a comprehensive review.Frontiers in immunology · 2026Review
- Effectiveness and Safety of Sacituzumab Govitecan in Real-World Clinical Practice in Patients with Metastatic Triple-Negative and HR+/HER2-Negative Breast Cancer.Biomedicines · 2025Article
- Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan.The oncologist · 2025Article
- Gastrointestinal toxicity of antibody-drug conjugates: a pharmacovigilance study using the FAERS database.BMC pharmacology & toxicology · 2025Article
- Drug risks associated with sarcopenia: a real-world and GWAS study.BMC pharmacology & toxicology · 2024Article
- Adverse event signal mining and serious adverse event influencing factor analysis of fulvestrant based on FAERS database.Scientific reports · 2024Article
- Myasthenia Gravis-Like Syndrome Resulting From Immune Checkpoint Inhibitors in a Patient With Urothelial Carcinoma.Cureus · 2024Article
- Comparative Analysis and Future Prospects of Human Epidermal Growth Factor Receptor 2 (HER2) and Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted Antibody-Drug Conjugates in Breast Cancer Treatment.Breast cancer (Dove Medical Press) · 2024Review
- Sacituzumab govitecan in triple-negative breast cancer: from bench to bedside, and back.Frontiers in immunology · 2024Review
- Sacituzumab-govitecan in metastatic triple-negative breast cancer: a multicenter effectiveness and safety study.Future oncology (London, England) · 2024Article
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Aim: The aim of this study was to identify potential safety concerns associated with Sacituzumab Govitecan (SG), an antibody-drug conjugate targeting trophoblastic cell-surface antigen-2, by analyzing real-world safety data from the largest publicly available worldwide pharmacovigilance database. Methods: All data obtained from the FDA Adverse Event Reporting System (FAERS) database from the second quarter of 2020 to the fourth quarter of 2022 underwent disproportionality analysis and Bayesian analysis to detect and assess the adverse event signals of SG, considering statistical significance when the lower limit of the 95% CI >1, based on at least 3 reports. Results: Total of 1072 cases were included. The main safety signals were blood and lymphatic system disorders [ROR(95CI)=7.23 (6.43-8.14)], gastrointestinal disorders [ROR(95CI)=2.01 (1.81-2.22)], and relative infection adverse events, such as neutropenic sepsis [ROR(95CI)=46.02 (27.15-77.99)] and neutropenic colitis [ROR(95CI)=188.02 (120.09-294.37)]. We also noted unexpected serious safety signals, including large intestine perforation [ROR(95CI)=10.77 (3.47-33.45)] and hepatic failure [ROR(95CI)=3.87 (1.45-10.31)], as well as a high signal for pneumonitis [ROR(95CI)=9.93 (5.75-17.12)]. Additionally, age sub-group analysis revealed that geriatric patients (>65 years old) were at an increased risk of neutropenic colitis [ROR(95CI)=282.05 (116.36-683.66)], neutropenic sepsis [ROR(95CI)=101.11 (41.83-244.43)], acute kidney injury [ROR(95CI)=3.29 (1.36-7.94)], and atrial fibrillation [ROR(95CI)=6.91 (2.86-16.69)]. Conclusion: This study provides crucial real-world safety data on SG, complementing existing clinical trial information. Practitioners should identify contributing factors, employ monitoring and intervention strategies, and focus on adverse events like neutropenic sepsis, large intestine perforation, and hepatic failure. Further prospective studies are needed to address these safety concerns for a comprehensive understanding and effective management of associated risks.
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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.