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Evaluation of cyclin-dependent kinase 4/6 inhibitor-induced serum creatinine elevations in patients with hormone receptor positive breast cancer.
J Oncol Pharm Pract
December 2024
Department of Pharmacy, University of Chicago Medicine, Chicago, IL, USA.
Background: Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) have improved the efficacy of endocrine therapy in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) and are now used in both early-stage and metastatic disease. Recent case reports suggest that pseudo-serum creatinine (Scr) elevations are likely a class effect of CDK4/6i.
Methods: This single-center retrospective analysis included patients aged ≥18 years who received at least one dose of palbociclib, ribociclib, or abemaciclib for the treatment of HR+/HER2- BC in the early or advanced setting.
Ribociclib-induced autoimmune-like hepatitis: a case report.
J Chemother
November 2024
Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkiye.
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer represents the most prevalent subtype of breast cancer. Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, in combination with endocrine therapy (ET), have shown substantial benefits in improving progression-free survival and, for ribociclib, an overall survival advantage. Despite clinical benefits, ribociclib is associated with elevated liver enzymes and severe liver dysfunction.
View Article and Find Full Text PDFRibociclib-Induced Autoimmune Hepatitis: A Case Report.
Cureus
October 2024
Department of Internal Medicine, Division of Gastroenterology, Hacettepe University, Ankara, TUR.
Drug-induced autoimmune hepatitis (DI-AIH) is a condition that mimics autoimmune hepatitis both histologically and clinically, making diagnosis challenging. Ribociclib, a CDK4/6 inhibitor used in the treatment of metastatic breast carcinoma, has been associated with rare cases of DI-AIH. We present the case of a 46-year-old woman undergoing treatment with ribociclib for metastatic breast carcinoma, who developed fatigue, skin rash, and significantly elevated liver enzymes two months into therapy.
View Article and Find Full Text PDFInvestigating the hepato-protective properties of chamomile oil and olive leaves extracts against ribociclib-induced hepatotoxicity.
Braz J Biol
October 2024
Zarqa University, Faculty of Allied Medical Sciences, Department of Medical Sciences, Zarqa, Jordan.
A new approach to overcome or reduce these toxicities is by using antioxidants. Ribociclib, a CDK4/6 inhibitor used in the treatment of breast cancer, has been linked to hepatotoxicity and may contribute to the development of Hepatocellular carcinoma in rats. This Study aims to assess hepatoprotective effect of chamomile oil and olive leaf extracts against ribociclib-induced Hepatotoxicity in rats.
View Article and Find Full Text PDFBuilding Confidence in Physiologically Based Pharmacokinetic Modeling of CYP3A Induction Mediated by Rifampin: An Industry Perspective.
Clin Pharmacol Ther
October 2024
DMPK, Research and Early Development, Oncology R&D, AstraZeneca, Boston, Massachusetts, USA.
Physiologically-based pharmacokinetic (PBPK) modeling offers a viable approach to predict induction drug-drug interactions (DDIs) with the potential to streamline or reduce clinical trial burden if predictions can be made with sufficient confidence. In the current work, the ability to predict the effect of rifampin, a well-characterized strong CYP3A4 inducer, on 20 CYP3A probes with publicly available PBPK models (often developed using a workflow with optimization following a strong inhibitor DDI study to gain confidence in fraction metabolized by CYP3A4, f, and fraction available after intestinal metabolism, Fg), was assessed. Substrates with a range of f (0.
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