Real-world evidence of ribociclib-induced hepatotoxicity in patients with breast cancer: a multi-center experience

作者：Onur Baş, Bediz Kurt İnci, İmdat Eroğlu, Safa Can Efil, Seher Kaya, Pınar Kubilay Tolunay, Taha Koray Şahin, Cengiz Karaçin, Ozan Yazıcı, Mehmet Alı Nahıt Şendur, Berna Ömür Çakmak Öksüzoğlu, Sercan Aksoy · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-15181-x · 被引用次数：1 · 研究领域：Advanced Breast Cancer Therapies、Cancer-related Molecular Pathways、HER2/EGFR in Cancer Research

BACKGROUND: CDK4/6 inhibitors are primarily used to treat hormone-positive HER-2 negative (HR+/ HER2-) metastatic breast cancer. Although ribociclib is generally well-tolerated, there is limited real-world data on hepatotoxicity associated with its use. Therefore, we evaluated the characteristics and management of ribociclib-induced hepatotoxicity. METHODS: Patients screened in the study received ribociclib for the treatment of metastatic HR+/ HER2- breast cancer between January 2019 and December 2023 at Hacettepe University Hospital, Ankara Bilkent City Hospital, Ankara Etlik City Hospital, Gazi University Hospital, and Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Ribociclib-induced hepatotoxicity was evaluated using retrospective laboratory results. The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was utilized to grade the severity of the liver injury. The primary objective of our study is to consider ribociclib-induced hepatotoxicity, with a view to providing information about this less common adverse event. The secondary objective of our study is to compare survival rates between patients who developed grade 1-2 hepatotoxicity and those who developed grade 3-4 hepatotoxicity. RESULTS: 845 patients were screened, and 78 (9.2%) were found to have developed ribociclib-induced hepatotoxicity. Of these, 5 (6.4%) had grade 4 toxicity, 19 (24.4%) had grade 3, and 54 (69.2%) had grade 1-2 toxicity. In patients with grade 4 toxicity, rib...