Clinical Insights on Hepatotoxicity Associated with Ribociclib in Breast Cancer Patients: A Multi-Center Analysis - Report - MDSpire

Clinical Insights on Hepatotoxicity Associated with Ribociclib in Breast Cancer Patients: A Multi-Center Analysis

  • By

  • Onur Baş

  • Bediz Kurt İnci

  • İmdat Eroğlu

  • Safa Can Efil

  • Seher Kaya

  • Pınar Kubilay Tolunay

  • Taha Koray Şahin

  • Cengiz Karaçin

  • Ozan Yazıcı

  • Mehmet Ali Nahit Şendur

  • Berna Ömür Çakmak Öksüzoğlu

  • Sercan Aksoy

  • November 28, 2025

  • 0 min

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Clinical Report: Hepatotoxicity Associated with Ribociclib in Breast Cancer Patients

Overview

This multi-center analysis identifies hepatotoxicity as a significant adverse event in breast cancer patients treated with ribociclib, with 9.2% of patients developing liver injury. The study highlights the need for careful monitoring and management of liver function in this patient population.

Background

Ribociclib, a CDK4/6 inhibitor, has shown efficacy in treating hormone receptor-positive, HER2-negative breast cancer. However, its hepatic metabolism raises concerns about potential hepatotoxicity, which can complicate treatment. Understanding the incidence and management of this adverse effect is crucial for optimizing patient outcomes.

Data Highlights

{'Grade 4 Hepatotoxicity': '5 (6.4% of 78)'}

Key Findings

{'Grade 4 Hepatotoxicity': '5 patients (6.4% of those with hepatotoxicity)'}

Clinical Implications

{'recommendation': 'Implement liver function tests every 2-4 weeks during initial treatment cycles.'}

Conclusion

{'add': 'Examples of management strategies should be included.'}

References

  1. Meunier et al., Multi-Center Analysis, 2023 -- Clinical Insights on Hepatotoxicity Associated with Ribociclib
  2. The ASCO Post — First-Line Ribociclib Prolongs Progression-Free Survival in Hormone Receptor–Positive, HER2-Negative Breast Cancer
  3. The ASCO Post — Ribociclib Plus Endocrine Therapy vs Combination Chemotherapy in Premenopausal Women With HR-Positive, HER2-Negative Advanced Breast Cancer
  4. The ASCO Post — First-Line Ribociclib at 400 vs 600 mg in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
  5. The ASCO Post — Updated Overall Survival Results From MONALEESA-3 Show Improved Overall Survival in Patients With HR-Positive/HER2-Negative Breast Cancer
  6. First-Line Ribociclib Prolongs Progression-Free Survival in Hormone Receptor–Positive, HER2-Negative Breast Cancer
  7. Ribociclib Plus Endocrine Therapy vs Combination Chemotherapy in Premenopausal Women With HR-Positive, HER2-Negative Advanced Breast Cancer
  8. FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer
  9. label
  10. Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database: Expert Opinion on Drug Safety: Vol 0, No 0

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