PD-1 억제제의 사용패턴 및 갑상선 관련 유해사례 발현 양상 분석
Usage Patterns and Incidence of Thyroid-related Adverse Events in Patients Treated with PD-1 Inhibitors
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Objective: PD-1 inhibitors have demonstrated improved health outcomes in cancer patients. PD-1 inhibitors are well-tolerated andassociated with immune-related adverse events. The objectives of this study are to analyze use patterns of PD-1 inhibitors in patientswith cancer and to investigate the incidence of thyroid-related adverse reactions in patients treated with PD-1 inhibitors. Methods:The study included patients who had been administered PD-1 inhibitors (either nivolumab or pembrolizumab) at the SamsungMedical Center between October 1, 2016 and June 30, 2017. Data was collected from electronic medical records and tested usingMann-Whitney tests and Chi-Square tests for statistical significance. Associations between PD-1 inhibitors and incidence of adverseevents were tested using Cox regression for age, gender, BMI, ECOG PS and medication. Results: Two hundred fifteen patientswere identified as eligible for analyses. Thyroid-related adverse events occurred in 20% of patients (n=43). Thyroid function tests(TFTs) was performed in 109 patients (50.7%). Positive results of PD-L1 testing were found in 53.2% of the 94 patients who had thetest. Approved doses of nivolumab (3 m/kg) and pembrolizumab (200 mg) were administered in 70.4% and 53% of patients,respectively. The analysis of risk factor of thyroid-related adverse reaction did not show statistically significant differences (Coxregression). Conclusion: Thyroid-related adverse events are common in patients treated with PD-1 inhibitors and hypothyroidism isthe most frequent adverse reaction. Routine TFTs monitoring is strongly recommended to evaluate thyroid function in real-worldclinical practice.
Abstract
Objective: PD-1 inhibitors have demonstrated improved health outcomes in cancer patients. PD-1 inhibitors are well-tolerated andassociated with immune-related adverse events. The objectives of this study are to analyze use patterns of PD-1 inhibitors in patientswith cancer and to investigate the incidence of thyroid-related adverse reactions in patients treated with PD-1 inhibitors. Methods:The study included patients who had been administered PD-1 inhibitors (either nivolumab or pembrolizumab) at the SamsungMedical Center between October 1, 2016 and June 30, 2017. Data was collected from electronic medical records and tested usingMann-Whitney tests and Chi-Square tests for statistical significance. Associations between PD-1 inhibitors and incidence of adverseevents were tested using Cox regression for age, gender, BMI, ECOG PS and medication. Results: Two hundred fifteen patientswere identified as eligible for analyses. Thyroid-related adverse events occurred in 20% of patients (n=43). Thyroid function tests(TFTs) was performed in 109 patients (50.7%). Positive results of PD-L1 testing were found in 53.2% of the 94 patients who had thetest. Approved doses of nivolumab (3 m/kg) and pembrolizumab (200 mg) were administered in 70.4% and 53% of patients,respectively. The analysis of risk factor of thyroid-related adverse reaction did not show statistically significant differences (Coxregression). Conclusion: Thyroid-related adverse events are common in patients treated with PD-1 inhibitors and hypothyroidism isthe most frequent adverse reaction. Routine TFTs monitoring is strongly recommended to evaluate thyroid function in real-worldclinical practice.
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