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.