2.6 Application of the method in Therapeutic Drug Monitoring
A total of 25 patients who were receiving adjuvant and neoadjuvant
treatment with imatinib for GIST in the Fourth Hospital of Hebei Medical
University, from October 2019 to October 2021, were enrolled in this
study. The study was approved by the Ethics Committee of the Fourth
Hospital of Hebei Medical University (No. 2019049) and and conducted in
accordance with the Basic & Clinical Pharmacology &
Toxicology policy for experimental and clinical
studies.22 Written informed consents were obtained
from themselves prior to their participation in the study. The exclusion
criteria were age <18 years old; severe organ dysfunction;
recurrence or distant metastasis at the initial diagnosis; poor
compliance. Patients taking imatinib continuously at a daily dose for ≥7
days to reach imatinib steady-state concentration. Blood samples were
collected into heparinized tubes before the next dosing. After
centrifugation for 10 min at 3000×g, the supernatant was divided and
stored in the refrigerator at -80℃ for testing.
Clinical data were recorded including demographic data (age, gender,
height, weight), duration of medication, concomitant medication, time of
blood sampling, primary tumor site, type of gene mutation, surgery,
adverse reactions (nausea, vomiting, leukopenia, anemia, limb edema,
periorbital edema, skin). Adverse reactions were graded according to the
Common Terminology Criteria for Adverse Events, version 5.0.