A single center retrospective study on sintilimab-induced thyroid immune-related adverse events in treatment of gastric cancer
Objective To investigate the occurrence,clinical features,and risk factors of thyroid immune-related adverse events(irAEs)in real-world patients with gastric cancer after treatment with sintilimab and establish a prediction model.Methods The clinical data of patients with gastric cancer treated with sintilimab in the Department of Gastrointestinal Surgery of Peking University People's Hospital from January 2021 to December 2022 were retrospectively analyzed,including gender,age,BMI,and occurrence of adverse drug reactions.The patients were divided into the occurrence group and the non-occurrence group according to whether they had thyroid irAEs.Logistic regression was used to analyze the risk factors of sintilimab-induced thyroid irAEs,and a prediction model was established.The receiver operating characteristic(ROC)curve was used to test the prediction model.Results A total of 91 patients were enrolled,including 65 males and 26 females,aged(60.62±12.39)years old.All patients received conventional dose therapy,6 patients received monotherapy,and 85 patients received combined chemotherapy or combined targeted therapy.A total of 31 cases(34.07%)had thyroid irAEs,including 7 cases(7.70%)of hypothyroidism,10 cases(10.99%)of subclinical hypothyroidism,2 cases(2.20%)of hyperthyroidism,and 12 cases(13.19%)of subclinical hyperthyroidism.Of the 31 patients who developed thyroid irAEs,27 occurred within 4 months of treatment initiation.Logistic regression analysis showed that after sintilimab treatment,the risk of thyroid irAEs in female patients with gastric cancer was 5.160 times higher than that in male patients with gastric cancer(OR=5.160,95%CI:1.578 to 16.865).The risk of thyroid irAEs increased by 8.472 times(OR=8.472,95%CI:2.723 to 26.366)in patients with a course of disease greater than or equal to one year compared with patients with a course of disease less than one year.The area under the ROC curve was 0.833±0.048(95%CI:0.739 to 0.927),the positive prediction accuracy was 71.0%,and the total prediction accuracy of the model was 79.1%.When the logit(P)prediction model equation≥0.253 318 8,it could be judged that the possibility of thyroid irAEs after the use of sintilimab was high.Conclusions Immune-related hypothyroidism is a common adverse effect of sintilimab,with a high incidence within 4 months of treatment initiation,but it is relatively mild in severity and does not require treatment withdrawal.Females and disease duration of longer than or equal to one year are risk factors for thyroid irAEs,and the established prediction model is reliable.
NETL
NSTL
万方数据
