Palbociclib-induced severe hepatitis: A case study and literature review

Abstract

Palbociclib is a selective and reversible CDK4/6 inhibitor approved for patients presenting with HR+ HER2– locally advanced or metastatic breast cancer. Its adverse effect (AE) is mainly reported on the occurrence of leukopenia and fatigue. Even though palbociclib has an extensive hepatic metabolism, there are rare reports about significant liver toxicity. We present a 61-year-old female with metastatic breast cancer treated with palbociclib and an aromatase inhibitor (letrozole). The patient developed a rare AE of severe acute drug-induced hepatitis but improved dramatically after stopping the palbociclib and receiving treatment with N-acetylcysteine (NAC). The treatment with NAC may be a proof of concept for the mechanism of palbociclib liver injury.

Large Ascites in a Cirrhotic Patient Reveal an Isolated and Late Metastasis of Ductal Breast Cancer: A Case Study

“…Considering the stability of her disease and the presence of liver cirrhosis, it was determined that discontinuing palbociclib was the most appropriate course of action. This decision was based on the potential risk of transaminitis and the rare but possible occurrence of fulminant hepatitis that can be associated with the use of this medication [11][12][13].…”

Hepatotoxicity After CDK 4/6 Inhibitor Initiation in the Treatment of Hormone-Positive Metastatic Breast Cancer

“…Similarly, abemaciclib has been shown to cause grade 3 hepatotoxicity within 60 days and will usually take 14 days to resolve below grade 3; LFT monitoring is recommended [ 6 ]. Palbociclib is less likely to cause hepatotoxicity, but case reports have reported this adverse effect [ 8 , 9 ]. We present a case in which hepatotoxicity was seen after initiation of ribociclib, and subsequently with palbociclib, for hormone-positive HER2-negative metastatic breast cancer.…”