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Infection associated with CDK4/6 inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system
Jinhua Chen1, Linlin Tang2, Wenping Song1
1Department of Pharmacy, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Henan Engineering Research Center for Tumor Precision Medicine and Comprehensive Evaluation, Henan Provincial Key Laboratory of Anticancer Drug Research, Zhengzhou, China.
Introduction:
Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are first-line treatments for hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer. With their increasing clinical use, infection-related adverse events (AEs) associated with CDK4/6 inhibitors have been widely reported in recent years. This study aimed to analyze the occurrence of infections associated with the CDK4/6 inhibitors (palbociclib, ribociclib and abemaciclib) based on the real-world data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
Data were extracted from the FAERS database between 2015Q1 and 2022Q3. The clinical characteristics of patients with primary suspected infection-related AEs were analyzed. A disproportionality analysis was performed to investigate the potential association between AEs and CDK4/6 inhibitors. The influencing factors were evaluated using Pearson's chi-square test.
Results:
Reports of infection-related AEs associated with ribociclib accounted for 8.58% of the total reports of AEs associated with ribociclib, followed by palbociclib (2.72%) and abemaciclib (1.24%). Ribociclib (67.65%) was associated with more serious outcome events than palbociclib (30%) or abemaciclib (48.08%). The sex and age were not associated with outcome severity. Disproportionality analysis showed that fourteen, sixteen and two infection-related preferred terms were detected for palbociclib, ribociclib and abemaciclib, respectively.
Conclusion:
Infection-related AEs were highly associated with three CDK4/6 inhibitors, especially palbociclib and ribociclib, based on the real-world data from the FAERS database. However, further causality assessment is required.
Insights
Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, used for breast cancer, are linked to infections. Ribociclib and palbociclib showed higher infection rates and serious outcomes in real-world data analysis.
Area of Science:
- Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are standard first-line therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
- Increasing clinical use of CDK4/6 inhibitors has led to reported infection-related adverse events (AEs).
Purpose of the Study:
- To analyze the occurrence of infections associated with CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib).
- To assess real-world data on infection-related AEs using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Main Methods:
- Extracted data from the FAERS database (2015Q1–2022Q3).
- Analyzed clinical characteristics of patients with infection-related AEs.
- Performed disproportionality analysis and Pearson's chi-square test to evaluate associations and influencing factors.
Main Results:
- Infection-related AEs were reported in 8.58% of ribociclib cases, 2.72% of palbociclib cases, and 1.24% of abemaciclib cases.
- Ribociclib had a higher rate of serious outcomes (67.65%) compared to abemaciclib (48.08%) and palbociclib (30%).
- Disproportionality analysis identified 14, 16, and 2 infection-related terms for palbociclib, ribociclib, and abemaciclib, respectively.
Conclusions:
- Infection-related AEs are significantly associated with palbociclib and ribociclib, based on FAERS data.
- Further causality assessment is necessary to confirm the association between CDK4/6 inhibitors and infection-related AEs.
