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Correlation analysis between plasma concentration of nilotinib and clinical efficacy and safety in patients with chronic myeloid leukemia: a single-center retrospective cohort study.


ABSTRACT:

Objective

This study aimed to investigate the correlation between nilotinib plasma concentrations and clinical efficacy and safety in patients with chronic myeloid leukemia (CML), thereby supporting personalized therapeutic optimization.

Methods

We conducted a retrospective cohort study of 121 CML patients receiving nilotinib with therapeutic drug monitoring (TDM) at Nanfang Hospital of Southern Medical University between March 2021 and February 2024. Major molecular response (MMR) and adverse events (CTCAE v5.0) were analyzed against concentrations. Receiver operating characteristic (ROC) curves defined thresholds; dose-normalized exposure (Cnorm = Cmin/(Dose/600 mg)) addressed TDM bias.

Results

The effective group showed higher nilotinib concen

SUBMITTER: Liu Y 

PROVIDER: S-EPMC12446310 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature