Clinical observation of thyroid-related adverse events induced by anti-PD-1 antibody SHR-1210 in patients with advanced solid tumor
10.3760/cma.j.issn.0253-3766.2018.10.009
- VernacularTitle: 程序性死亡蛋白1抗体SHR－1210治疗晚期实体瘤的甲状腺功能相关不良反应
- Author:
Ling QI
1
;
Hongnan MO
1
;
Xuelian CHEN
1
;
Xi WANG
1
;
Dawei WU
1
;
Bo LAN
1
;
Qun LI
1
;
Xingyuan WANG
1
;
Jianping XU
1
;
Qing YANG
2
;
Binghe XU
1
;
Jing HUANG
1
Author Information
1. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
2. Jiangsu Hengrui Medicine Co., Ltd, Lianyungang 210000, China
- Publication Type:Clinical Trail
- Keywords:
Neoplasms;
anti-PD-1 antibody;
Thyroid;
Adverse events;
Immunotherapy
- From:
Chinese Journal of Oncology
2018;40(10):772-775
- CountryChina
- Language:Chinese
-
Abstract:
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 advanced solid tumor.
Methods:The medical records of 98 patients who initiated SHR-1210 treatment between April 27, 2016 and June 8, 2017 in the phase 1 trial to evaluate the safety, efficacy, and pharmacokinetics of SHR-1210 in patients with advanced solid tumors were retrospectively reviewed. Serological tests of thyroid stimulating hormone (TSH) and free thyroxine (fT4) were measured at baseline and prior to each SHR-1210 administration.
Results:A total of 86 patients had normal thyroid function before the first dose of SHR-1210 treatment. Nine out of 86 (10.5%) patients developed new onset hypothyroidism from euthyroid state. 12 patients presented thyroid dysfunction at baseline, 10 of whom were subclinical hypothyroid and 2 were hypothyroidism. Four out of 10 patients developed hypothyroidism from subclinical hypothyroid. Most patients with hypothyroidism were asymptomatic. Thyroid dysfunction occurred early (median, 55days) after the initiation of SHR-1210. The severity of hypothyroidism were all grade 1-2. No grade 3-4 hypothyroidism occurred. No patients discontinue the treatment of SHR-1210 due to clinical impact of the thyroid dysfunctions.
Conclusions:Thyroid-related adverse events were common during anti-PD-1 antibody SHR-1210 treatment . The incidence of hypothyroidism is lower in patients with euthyroid state than in patients with thyroid dysfunction at baseline during SHR-1210 treatment . Thyroid function can be improved after thyroid hormone replacement. During SHR-1210 treatment, it is necessary to pay attention to monitor the thyroid function, especially in the patients with thyroid dysfunction at baseline.
Trial registration:Chinese Clinical Trial Registry, 2016L01455
