The First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, China.
Department of Endocrinology, the First Hospital of Lanzhou University, Lanzhou, Gansu, China.
J Clin Pharmacol. 2021 Mar;61(3):282-297. doi: 10.1002/jcph.1804. Epub 2021 Jan 12.
The aim of this meta-analysis was to assess the risks of endocrine adverse events in patients with malignancies treated with different types and different doses of immune checkpoint inhibitors (ICIs). PubMed and Embase were searched for randomized controlled trials on ICIs and endocrine adverse events since 2000, and meta-analysis was carried out. Twenty-six randomized controlled trials comprising 13 824 patients with malignancies were included. Compared with the other tumor therapies (used as a control group), patients treated with programmed death-1 inhibitors appeared to be at higher risks of hypothyroidism, hyperthyroidism, thyroiditis, hypophysitis or hypopituitarism, and type 1 diabetes mellitus, while there was no difference in the risk of primary adrenal insufficiency. It was also found that patients treated with cytotoxic T-lymphocyte-associated protein-4 inhibitors were at higher risk of hypophysitis or hypopituitarism, primary adrenal insufficiency, and hypothyroidism. In comparison, patients treated with programmed death-ligand 1 inhibitors were at higher risk of hyperthyroidism and hypothyroidism. Compared with the control group, both low-dose and high-dose ICI groups were at higher risk of hypothyroidism and hyperthyroidism, and the low-dose group had increased risk of thyroiditis and primary adrenal insufficiency. There was no significant difference in the risk of type 1 diabetes between the low-dose group and the high-dose group. The risk of hypophysitis or hypopituitarism in the high-dose group (relative risk, 20.12; 95% confidence interval, 8.02-50.46) was significantly higher than that in the low-dose group (relative risk, 4.92; 95% confidence interval, 2.11-11.47). The risk of endocrine adverse events was increased in patients treated with ICIs. Different types and doses of ICIs have varying characteristics of endocrine adverse events.
本荟萃分析旨在评估不同类型和剂量的免疫检查点抑制剂(ICI)治疗恶性肿瘤患者的内分泌不良事件风险。检索了 2000 年以来关于 ICI 和内分泌不良事件的随机对照试验,并进行了荟萃分析。共纳入 26 项包含 13824 例恶性肿瘤患者的随机对照试验。与其他肿瘤治疗方法(作为对照组)相比,使用程序性死亡-1 抑制剂治疗的患者发生甲状腺功能减退症、甲状腺功能亢进症、甲状腺炎、垂体炎或垂体功能减退症和 1 型糖尿病的风险更高,而原发性肾上腺功能不全的风险没有差异。还发现,使用细胞毒性 T 淋巴细胞相关蛋白-4 抑制剂治疗的患者发生垂体炎或垂体功能减退症、原发性肾上腺功能不全和甲状腺功能减退症的风险更高。相比之下,使用程序性死亡配体 1 抑制剂治疗的患者发生甲状腺功能亢进症和甲状腺功能减退症的风险更高。与对照组相比,低剂量和高剂量 ICI 组均有更高的发生甲状腺功能减退症和甲状腺功能亢进症的风险,低剂量组发生甲状腺炎和原发性肾上腺功能不全的风险增加。低剂量组和高剂量组之间发生 1 型糖尿病的风险无显著差异。高剂量组(相对风险,20.12;95%置信区间,8.02-50.46)发生垂体炎或垂体功能减退症的风险显著高于低剂量组(相对风险,4.92;95%置信区间,2.11-11.47)。ICI 治疗患者的内分泌不良事件风险增加。不同类型和剂量的 ICI 具有不同的内分泌不良事件特征。