Palbociclib Is Safe for Breast Cancer Patients With Mild Hepatic Impairment: A Multicenter Retrospective Study Using Real-World Data

Alieke K Bos ¹, Annelieke E C A B Willemsen ², Loes E Visser ^3,4

⁰Department of Clinical Pharmacy, Tergooi Medical Centre, Hilversum, The Netherlands.

Clinical Pharmacology and Therapeutics +

|

January 24, 2025

View abstract on PubMed

Summary

Mild hepatic impairment does not increase the risk of neutropenia or disease progression in breast cancer patients treated with palbociclib. Real-world data shows similar outcomes for patients with normal and mild liver dysfunction, guiding clinical decisions.

Area Of Science

Oncology
Pharmacology
Hepatology

Background

The liver is vital for metabolizing palbociclib, an anticancer drug.
Limited real-world data exists on hepatic impairment's effect on palbociclib toxicity and efficacy.
Understanding these effects is crucial for treating breast cancer patients with liver dysfunction.

Purpose Of The Study

To evaluate the impact of mild hepatic impairment on hematological toxicity and progression-free survival (PFS) in breast cancer patients receiving palbociclib.
To compare outcomes between patients with normal and mild hepatic function using real-world data.
To provide evidence-based guidance for palbociclib treatment in patients with mild liver impairment.

Main Methods

A multicenter retrospective observational study of 478 female patients treated with palbociclib (August 2017 - February 2024).
Patients were categorized into normal and mild hepatic function groups based on the National Cancer Institute scoring system.
Regression analysis was used to compare the risk of grade 3/4 hematological toxicity and PFS between the groups.

Main Results

Patients with mild hepatic impairment (n=205) showed no increased risk of grade 3/4 neutropenia compared to those with normal hepatic function (n=273) (HR=1.11; 95% CI 0.83-1.47).
Progression-free survival (PFS) was not significantly different between the mild hepatic impairment and normal hepatic function groups (HR=1.15; 95% CI 0.93-1.42).
Real-world data indicates comparable safety and efficacy of palbociclib in patients with mild hepatic impairment versus normal hepatic function.

Conclusions

Mild hepatic impairment does not elevate the risk of palbociclib-induced neutropenia in breast cancer patients.
Palbociclib treatment in patients with mild hepatic impairment demonstrates similar progression-free survival compared to those with normal liver function.
These findings support the use of palbociclib in breast cancer patients with mild hepatic impairment, informing clinical practice.

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