Hepatotoxicity in patients undergoing systemic treatment with Ribociclib

Introduction: Only scarce data exists regarding hepatoxicity in patients (pts) undergoing treatment with Ribociclib.

Material and methods: We performed a retrospective monocentric chart review of 107 hormone receptor-positive metastatic breast cancer pts, who received Ribociclib between 2017 and 2024. Liver enzymes were evaluated by Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0).

Results: 84 pts were included into analysis. 23 pts were excluded because of missing follow-up data. Median age was 56 years (range 27-83). At baseline, 31/84 (37%) pts presented with liver metastasis and 25 of them had elevated liver enzymes. At data cut off (02.02.2025) 23/84 pts were still on treatment.

Elevation of liver enzymes of more than one grade was observed in 11/84 (13%) pts (maximal grades: 1=1 pt; 2=3 pts; 3=3 pts; 4=4 pts). 5 of them had hepatic metastasis. One patient was excluded because of hepatic progression at this time. Treatment associated liver toxicity was histologically confirmed in 2 pts by liver biopsy. In 9/10 pts treatment with Ribociclib was discontinued. The average duration until liver enzymes declined was 82 days and 133 days until all pts declined to grade 1. 7/9 pts continued with Abemaciclib, without further relevant liver toxicity.

Conclusion: Therapy with Ribociclib treatment can cause liver enzyme elevation which might require treatment discontinuation. Further studies are planned to investigate the underlying mechanism, possible risk factors and the role of corticosteroid in the clinical management. At the congress we will present a further update of the cohort treated with Ribociclib.

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Artikel online veröffentlicht:
04. Juni 2025