ArticleJournal of the Chinese Medical Association : JCMA2026
Risk factors of hepatotoxicity with ribociclib in hormone receptor-positive breast cancer.
Article in Journal of the Chinese Medical Association : JCMA, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe standard first-line treatment for hormone receptor-positive metastatic breast cancer is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, including palbociclib, ribociclib, or abemaciclib, combined with endocrine therapy. Hepatobiliary toxicity is an important adverse effect of ribociclib. This study compared the risk of hepatotoxicity between ribociclib and palbociclib and identified factors associated with hepatotoxicity.
methodsThis retrospective cohort study included patients with hormone receptor-positive breast cancer receiving ribociclib or palbociclib between January 1, 2018, and June 1, 2022. Hepatotoxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, with grade 2 or higher considered as the study outcome. Kaplan-Meier analysis assessed time to hepatotoxicity, and a multivariable Cox proportional hazards model estimated adjusted hazard ratios.
resultsThe mean age was 61 years, and all patients were women. Among 145 patients receiving ribociclib, 28 developed hepatotoxicity, compared with 19 of 153 patients receiving palbociclib. The median time to hepatotoxicity was 42 days in both groups. After adjustment for age, Charlson Comorbidity Index (CCI) score, history of hepatitis B virus (HBV) infection, fatty liver, and liver metastasis, the adjusted hazard ratio (HR) for palbociclib compared with ribociclib was 0.467 (95% CI, 0.233-0.936; p = 0.0320). In the overall population, liver metastasis (HR, 2.159; 95% CI, 1.175-3.966; p = 0.0131), history of HBV infection (HR, 2.216; 95% CI, 1.102-4.458; p = 0.0256), and fatty liver (HR, 3.536; 95% CI, 1.840-6.794; p = 0.0002) were associated with higher risk of hepatotoxicity.
conclusionCompared with palbociclib, ribociclib was associated with a higher risk of hepatotoxicity during the first 6 months of treatment. Closer monitoring of liver function may be warranted, particularly in patients with liver metastases, a history of HBV infection, or fatty liver who receive ribociclib.
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