| アブストラクト | AIMS: This study aimed to evaluate the comprehensive safety profile of CDK4/6 inhibitors in breast cancer treatment by analyzing real-world adverse event (AE) data and systematically reviewing clinical trial findings to provide evidence-based safety guidance. METHODS: A disproportionality analysis based on real-world data from the FDA adverse event reporting system (FAERS) was combined with a systematic review to evaluate adverse events (AEs) associated with CDK4/6 inhibitors. A total of 16 studies involving 6,722 patients with advanced breast cancer were included to analyze the toxicity risks of CDK4/6 inhibitor combination therapies. Temporal patterns of AEs were assessed using FAERS data, and signal strengths were determined using the reporting odds ratio (ROR). RESULTS: Combination therapy with CDK4/6 inhibitors significantly increased the risk of grade 3-5 AEs. FAERS analysis revealed that most AEs occurred within the first month of treatment, with the lowest incidence between the second and sixth months, followed by a significant rise thereafter. All CDK4/6 inhibitors were associated with myelosuppression, gastrointestinal toxicity, interstitial lung disease (ILD), and QT prolongation. Disproportionality analysis for "Torsade de pointes/QT prolongation" identified Ribociclib as the only agent with a strong positive signal (ROR 6.16, 95% CI 5.54-6.84). Additionally, unexpected AEs such as peripheral neuropathy, taste disorders, and epistaxis were detected. CONCLUSION: Clinicians should prioritize monitoring for myelosuppression, gastrointestinal toxicity, and QT prolongation (particularly with Ribociclib) during the first month of CDK4/6 inhibitor therapy. Long-term surveillance beyond 6 months is crucial to detect delayed-onset AEs. |
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| ジャーナル名 | Frontiers in oncology |
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| Pubmed追加日 | 2025/12/29 |
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| 投稿者 | Zhou, Jin; Lin, Xinmiao; Wang, Shue; Xie, Mumu; Hu, Xiao; Cai, Jiaqin |
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| 組織名 | Department of Pharmacy, Fujian Maternity and Child Health Hospital, Fuzhou,;China.;School of Pharmacy, Fujian Medical University, Fuzhou, China.;Information Management Department, Key Laboratory of Medical Big Data;Engineering, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China.;Department of Pharmacy, Fujian Provincial Hospital, Shengli Clinical Medical;College of Fujian Medical University, Fuzhou University Affiliated Provincial;Hospital, Fuzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41458615/ |
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