98%
921
2 minutes
20
Background: Palbociclib and abemaciclib are cyclin-dependent kinase (CDK) 4/6 inhibitors currently used to treat breast cancer. Although their therapeutic efficacies are considered comparable, differences in adverse event (AE) profiles of the two drugs remain unclear.
Aim: We analysed two real-world databases, the World Health Organization's VigiBase and the Food and Drug Administration Adverse Event Reporting System (FAERS), to identify differences in AE profiles of palbociclib and abemaciclib.
Method: Data of patients with breast cancer receiving palbociclib or abemaciclib recorded until December 2022 were extracted from the VigiBase and FAERS databases. In total, 200 types of AEs were analysed. The reporting odds ratios were calculated using a disproportionality analysis.
Results: Cytopenia was frequently reported in patients receiving palbociclib, whereas interstitial lung disease and diarrhoea were frequently reported in those receiving abemaciclib. Moreover, psychiatric and nervous system disorders were more common in the palbociclib group, whereas renal and urinary disorders were more common in the abemaciclib group.
Conclusion: This study is the first to show comprehensively the disparities in the AE profiles of palbociclib and abemaciclib. The findings highlight the importance of considering these differences when selecting a suitable CDK4/6 inhibitor to ensure safe and favourable outcomes for patients with breast cancer.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1007/s11096-023-01687-6 | DOI Listing |
ESMO Open
September 2025
UPMC Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, USA.
Background: All three cyclin-dependent kinase 4/6 inhibitors (CDK4/6i; palbociclib, ribociclib, and abemaciclib) plus aromatase inhibitor (AI) significantly prolonged progression-free survival (PFS) versus placebo plus AI and achieved a similar reduction in risk of disease progression in randomized controlled trials (RCTs) evaluating first-line (1L) treatment of hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC). To date, there have been no head-to-head RCT data comparing CDK4/6i, and most real-world comparative effectiveness studies were limited by small sample sizes and/or short follow-up. In this analysis, we compared real-world PFS (rwPFS) in patients with HR-positive/HER2-negative mBC receiving 1L CDK4/6i plus AI in United States routine clinical practice.
View Article and Find Full Text PDFFront Oncol
August 2025
Hematology and Medical Oncology, St. Luke's Cancer Institute, Kansas City, MO, United States.
Background And Aim: The HR-positive/HER2-negative (HR+/HER2-) advanced/metastatic breast cancer (a/mBC) treatment landscape has advanced with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), yet outcome disparities persist, particularly among older patients and black, indigenous, and people of color (BIPOC) communities. Emerging real-world evidence (RWE) since 2021 highlights the need for this updated systematic literature review.
Methods: Searches were conducted in MEDLINE, Embase, and Cochrane Databases (07/06/2019-01/09/2024) and key congress proceedings (2020-2024).
PLoS One
August 2025
Biophysics Department, Faculty of Science, Cairo University, Giza, Egypt.
Dysregulation of the cyclin D/CDK complex is a common feature in various cancers, including colorectal, breast, and melanoma, leading to uncontrolled tumor growth and cell cycle progression. Targeting this complex has become a compelling therapeutic approach in oncology. FDA-approved CDK4/6 inhibitors, such as ribociclib, palbociclib, and abemaciclib, have demonstrated clinical efficacy, significantly improving patient outcomes.
View Article and Find Full Text PDFJ Oncol Pharm Pract
August 2025
Pharmaceutical Practices Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
ObjectiveCyclin-dependent kinase (CDK) 4/6 inhibitors have become a cornerstone in the treatment of hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, demonstrating significant efficacy in both early and metastatic stages. However, despite their clinical benefits, emerging evidence from health databases, real-world studies, and case reports highlight potential cardiovascular risks, including QTc prolongation and thrombosis. This review aims to comprehensively evaluate the cardiovascular safety profiles of the three FDA-approved CDK4/6 inhibitors-palbociclib, ribociclib, and abemaciclib-in patients with HR+/HER2- advanced breast cancer.
View Article and Find Full Text PDFVitam Horm
August 2025
Department of Cancer Biology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, United States; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States. Electronic address:
FDA approval of selective CDK4/6 inhibitors (CDK4/6i) marked a groundbreaking development in cancer treatment. Decades of pre-clinical studies elucidated the route that certain cancer cells take to gain the cancer hallmark of uncontrolled proliferation, uncovering CDK4/6 as key players. Further investigation into the molecular underpinnings of this process revealed interconnected signaling between the CDK4/6 and estrogen receptor (ER) signaling axes, providing evidence that CDK4/6i would be particularly relevant in estrogen-driven cancers.
View Article and Find Full Text PDF