Clinical Observation Of Thyroid-related Adverse Events Induced By Anti-PD-1 Antibody SHR-1210 In Patients With Solid Tumor

Objective:To assess the incidence and characteristics of thyroid dysfunction during anti-Programmed cell death 1 receptor(PD-1)antibody SHR-1210 therapy in patients with solid tumor.Methods:Retrospective review of the medical records of 98 patients who initiated treatment between April 27,2016 and June 8,2017,in the phase 1 study to evaluate the safety,activity,and pharmacokinetics of SHR-1210 in patients with advanced solid tumors.Serological tests of thyroid stimulating hormone(TSH)and free thyroxine(fT4)were measured at baseline and prior to each SHR-1210 administration.Results:Up to October 1,2017,a total of 98 patients accepted SHR-1210 treatment,12 presented thyroid dysfunction at baseline(10 were subclinical hypothyroid and 2 were hypothyroidism),and 4 of 10(40.0%)patients developed hypothyroidism from subclinical hypothyroid.9 of 86(10.5%)patients developed new onset hypothyroidism from euthyroid state.Most patients with hypothyroidism were asymptomatic.Thyroid dysfunction occurred early(median,55days).The severity of hypothyroidism was gradeⅠ-Ⅱ,no Ⅲ-Ⅳ occurred.No patients discontinue the treatment of SHR-1210 due to clinical impact of the thyroid dysfunctions.Conclusion:Thyroid-related adverse events during anti-PD-1 antibody SHR-1210 treatment is common.The incidence of hypothyroidism is lower among patients with euthyroid state at baseline during SHR-1210 treatment than in patients with thyroid dysfunction at baseline.Thyroid function can be improved after thyroid hormone replacement therapy.During SHR-1210 treatment,it is necessary to pay attention to monitor the thyroid function of all the patients.