September 10, 2025Investigational New DrugsOpen Access

Pharmacokinetics, efficacy and safety of palbociclib and fulvestrant in a patient with hormone receptor-positive, human epidermal growth factor receptor 2 negative metastatic breast cancer with end-stage renal disease undergoing hemodialysis: A case report

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Discussion

Case report highlights efficacy and pharmacokinetics of palbociclib and fulvestrant in ESRD patients, suggesting safe treatment.

Stable disease was maintained for 18 months in a patient with end-stage renal disease undergoing hemodialysis.
Total exposure (AUC0-24) of palbociclib was higher in the patient than in those with normal renal function receiving standard doses.
Fulvestrant plasma concentrations remained effective, indicating a manageable treatment approach for breast cancer.
Combination therapy of palbociclib and fulvestrant shows promise for patients with renal impairment, based on observed pharmacokinetics.

Takakura et al. (2025) studied this question.

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