Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review

Gao, Siyuan; Yu, Li; He, Ziwen; Zhu, Jianhong; Liang, Dan; Yang, Shan; Mo, Jiayao; Lam, Kakei; Yu, Xinmin; Huang, Ming; Wu, Junyan

doi:10.1080/14740338.2023.2181338

Cited by 5 publications

(3 citation statements)

References 52 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It's open to researchers for pharmacovigilance and pharmacoepidemiologic studies. Based on the FAERS, previous pharmacovigilance studies have elucidated the relationship between CDK4/6i and several AEs, including thromboembolism, 29 hematopoietic cytopenia, 30 skin toxicities 31 and interstitial lung disease. 32 …”

Section: Discussionmentioning

confidence: 99%

“…to researchers for pharmacovigilance and pharmacoepidemiologic studies. Based on the FAERS, previous pharmacovigilance studies have elucidated the relationship between CDK4/6i and several AEs, including thromboembolism, 29 hematopoietic cytopenia, 30 skin toxicities 31 and interstitial lung disease. 32 It is generally accepted that patients with breast cancer are susceptible to psychiatric illnesses, such as depression, anxiety and sexual dysfunction.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Spectrum of psychiatric adverse reactions to cyclin‐dependent kinases 4/6 inhibitors: A pharmacovigilance analysis of the FDA adverse event reporting system

Xiao,

Cao,

et al. 2024

CNS Neurosci Ther

View full text Add to dashboard Cite

BackgroundThe emergence of cyclin‐dependent kinases 4/6 inhibitors (CDK4/6i) represented a major breakthrough in the treatment of breast cancer over the past decade. In both clinical trials and real‐world settings, it was observed that patients using CDK4/6i might experience psychiatric adverse events (PAEs). Herein, we conducted a pharmacovigilance study to comprehensively assess the correlation between CDK4/6i and PAEs.MethodWe obtained individual case safety reports submitted to the FDA Adverse Events Reporting System (FAERS) during the period from January 2015 to December 2023. In disproportionality analysis, the reporting odds ratio (ROR) and information component (IC) values were calculated for each adverse event‐drug combination. Univariate logistic regression analysis was utilized to explore factors associated with PAEs following CDK4/6i treatment.ResultsA total of 95,591 reports related to CDK4/6i were identified, with 6.72% reporting PAEs, and this proportion exhibited an annual upward trend. Based on the ROR and IC values, 17 categories of PAEs were defined as CDK4/6i‐related PAEs. Among these PAEs, insomnia, stress, eating disorder, depressed mood, and sleep disorder were very common, each accounting for over 10% of CDK4/6i reports. Ribociclib showed the highest risk signal of CDK4/6i‐related PAEs (ROR = 1.89[1.75–2.04], IC025 = 0.79), followed by palbociclib (ROR = 1.47[1.41–1.53], IC025 = 0.49), while abemaciclib did not exhibit a significant signal (ROR = 0.52[0.44–0.62], IC025 = −1.13). Female sex, younger age and weight exceeding 80 kg were significant risk factors for the incidence of CDK4/6i‐related PAEs.ConclusionsUsing data from a real‐world, large‐scale spontaneous reporting system for adverse drug reactions, our study delineated the spectrum of PAEs to CDK4/6i. This potentially offered valuable insights for healthcare professionals to manage the risk of PAEs in patients receiving CDK4/6i treatment, particularly those with psychiatric disorders.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Spectrum of psychiatric adverse reactions to cyclin‐dependent kinases 4/6 inhibitors: A pharmacovigilance analysis of the FDA adverse event reporting system

Xiao,

Cao,

et al. 2024

CNS Neurosci Ther

View full text Add to dashboard Cite

show abstract

“…To the best of our knowledge, our mining of AEs to palbociclib used more algorithms, and described more comprehensively [19][20][21][22][23] . Compared with MGPS, PRR has higher sensitivity but lower speci city 24 .…”

Section: Discussionmentioning

confidence: 99%

Post-Marketing Safety Concerns With Palbociclib A Disproportionality Analysis of the FDA Adverse Event

Qing

Shi

Zhao

et al. 2023

Preprint

View full text Add to dashboard Cite

Purpose: By using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, the adverse reactions (ADRs) of palbociclib were mined through disproportionality analysis, so as to provide reference for rational use of palbociclib. Methods: Data mining of palbociclib-associated adverse events (AEs) was done by reporting odds ratio (ROR), proportional reporting odds ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinkage (MGPS) algorithms. Findings: At the SOC level, the four algorithms simultaneously detected 18 positive signals, and at the PT level, the four algorithms simultaneously detected 65 positive signals. The PTs that lead to severe outcome are mainly associated with pulmonary toxicity, hematological toxicity and myelosuppression. Palbociclib-associated AEs had a median onset time of 79 days (interquartile range [IQR] 20-264 days), with the majority occurring within the first 1, 2, 3 months, and one year of treatment. Implications: The study identified potential palbociclib side effects and offered warnings for high-risk AEs, providing further data for palbociclib safety studies in breast cancer patients. Nonetheless, prospective clinical trials are needed to validate these results and explain their relationship.

show abstract

CDK4/6 inhibitors in the treatment of metastatic breast cancer: Focus on toxicity and safety

Wekking,

Lambertini,

Dessì

et al. 2023

Seminars in Oncology

View full text Add to dashboard Cite

Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review

Cited by 5 publications

References 52 publications

Spectrum of psychiatric adverse reactions to cyclin‐dependent kinases 4/6 inhibitors: A pharmacovigilance analysis of the FDA adverse event reporting system

Spectrum of psychiatric adverse reactions to cyclin‐dependent kinases 4/6 inhibitors: A pharmacovigilance analysis of the FDA adverse event reporting system

Post-Marketing Safety Concerns With Palbociclib A Disproportionality Analysis of the FDA Adverse Event

CDK4/6 inhibitors in the treatment of metastatic breast cancer: Focus on toxicity and safety

Contact Info

Product

Resources

About