Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center

Abstract Objective To investigate the clinical characteristics, related risk factors and outcomes of thyroid immune-related adverse events (irAEs) in patients with malignant solid tumor treated with programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) inhibitors in a large tertia...

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Main Authors: Wenwen Gong, Erhan Zheng, Minchao Liu, Yaliang Han, Zhaohui Lyu, Qinghua Guo
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Endocrine Disorders
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Online Access:https://doi.org/10.1186/s12902-025-01986-1
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author Wenwen Gong
Erhan Zheng
Minchao Liu
Yaliang Han
Zhaohui Lyu
Qinghua Guo
author_facet Wenwen Gong
Erhan Zheng
Minchao Liu
Yaliang Han
Zhaohui Lyu
Qinghua Guo
author_sort Wenwen Gong
collection DOAJ
description Abstract Objective To investigate the clinical characteristics, related risk factors and outcomes of thyroid immune-related adverse events (irAEs) in patients with malignant solid tumor treated with programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) inhibitors in a large tertiary Chinese center. Methods We retrospectively analyzed the clinical data of 1151 patients with malignant solid tumors who received PD-1 or PD-L1 inhibitors treatment and underwent thyroid function evaluation in a large 3 A hospital of Beijing from September 2019 to December 2023. According to the thyroid status after receiving PD-1/PD-L1 inhibitors treatment, patients were divided into normal thyroid group and thyroid irAEs group. The clinical characteristics, including age, gender, tumor type, previous anti-cancer treatment history and thyroid function status were evaluated. After the occurrence of thyroid irAEs, thyroid function evaluation, onset time, and survival outcomes were analyzed. Risk factors that may contribute to the thyroid irAEs were further explored by logistic regression. Results Out of 1151 patients treated with a PD-1/PD-L1 inhibitor, 257 (22.3%) developed new thyroid irAEs, with the vast majority (98.0%) being hypothyroidism (193/257, 75.1%) and Grade1-2 (252/257, 98.0%), including 252 Hashimoto’s thyroiditis (98.0%), 3 subacute thyroiditis (1.17%) and 2 Graves’ disease (0.78%). There was a significant difference in the number of treatment cycles of PD-1/PD-L1 inhibitors between the two groups (P = 0.001). In multivariate analysis, gastrointestinal cancer, radiotherapy history, targeted therapy history, positive TgAb and TPOAb at baseline were associated with thyroid irAEs caused by PD-1/PD-L1 inhibitors. Absence of thyroid irAEs predicted increased mortality overall (HR = 2.935, P = 0.024) and particularly in gastrointestinal cancers (HR = 9.453, P = 0.007), despite comparable crude mortality (5.84% vs. 5.82%, P = 0.228). No association was observed in lung/other tumors. Thyroid function recovery occurred in 36.2% of patients, and treatment interruption due to thyroid irAEs was rare (3.5%). Conclusion In our group, 22.3% patients treated with PD-1/PD-L1 inhibitors developed thyroid irAEs. The main subtype of thyroid irAEs was hypothyroidism (75.1%). Patients with gastrointestinal cancer, previous radiotherapy, history of targeted therapy, and baseline TgAb or TPOAb positivity may increase the risk of thyroid irAEs. Thyroid irAEs was associated with a trend for a survival benefit in patients with gastrointestinal cancer.
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spelling doaj-art-8924e3073c1e47aa82fb367a6bd0f1712025-08-20T04:02:56ZengBMCBMC Endocrine Disorders1472-68232025-07-0125111110.1186/s12902-025-01986-1Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese centerWenwen Gong0Erhan Zheng1Minchao Liu2Yaliang Han3Zhaohui Lyu4Qinghua Guo5Department of Endocrinology, the First Medical Center, Chinese PLA General HospitalSchool of Basic Sciences, Clinical Medicine Class 2, Capital Medical UniversityDepartment of Information, the Medical Supplies Center, Chinese PLA General HospitalDepartment of Pharmacy, the Medical Supplies Center, Chinese PLA General HospitalDepartment of Endocrinology, the First Medical Center, Chinese PLA General HospitalDepartment of Endocrinology, the First Medical Center, Chinese PLA General HospitalAbstract Objective To investigate the clinical characteristics, related risk factors and outcomes of thyroid immune-related adverse events (irAEs) in patients with malignant solid tumor treated with programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) inhibitors in a large tertiary Chinese center. Methods We retrospectively analyzed the clinical data of 1151 patients with malignant solid tumors who received PD-1 or PD-L1 inhibitors treatment and underwent thyroid function evaluation in a large 3 A hospital of Beijing from September 2019 to December 2023. According to the thyroid status after receiving PD-1/PD-L1 inhibitors treatment, patients were divided into normal thyroid group and thyroid irAEs group. The clinical characteristics, including age, gender, tumor type, previous anti-cancer treatment history and thyroid function status were evaluated. After the occurrence of thyroid irAEs, thyroid function evaluation, onset time, and survival outcomes were analyzed. Risk factors that may contribute to the thyroid irAEs were further explored by logistic regression. Results Out of 1151 patients treated with a PD-1/PD-L1 inhibitor, 257 (22.3%) developed new thyroid irAEs, with the vast majority (98.0%) being hypothyroidism (193/257, 75.1%) and Grade1-2 (252/257, 98.0%), including 252 Hashimoto’s thyroiditis (98.0%), 3 subacute thyroiditis (1.17%) and 2 Graves’ disease (0.78%). There was a significant difference in the number of treatment cycles of PD-1/PD-L1 inhibitors between the two groups (P = 0.001). In multivariate analysis, gastrointestinal cancer, radiotherapy history, targeted therapy history, positive TgAb and TPOAb at baseline were associated with thyroid irAEs caused by PD-1/PD-L1 inhibitors. Absence of thyroid irAEs predicted increased mortality overall (HR = 2.935, P = 0.024) and particularly in gastrointestinal cancers (HR = 9.453, P = 0.007), despite comparable crude mortality (5.84% vs. 5.82%, P = 0.228). No association was observed in lung/other tumors. Thyroid function recovery occurred in 36.2% of patients, and treatment interruption due to thyroid irAEs was rare (3.5%). Conclusion In our group, 22.3% patients treated with PD-1/PD-L1 inhibitors developed thyroid irAEs. The main subtype of thyroid irAEs was hypothyroidism (75.1%). Patients with gastrointestinal cancer, previous radiotherapy, history of targeted therapy, and baseline TgAb or TPOAb positivity may increase the risk of thyroid irAEs. Thyroid irAEs was associated with a trend for a survival benefit in patients with gastrointestinal cancer.https://doi.org/10.1186/s12902-025-01986-1Thyroid irAEsRisk factorsMalignant solid tumorPD-1/PD-L1 inhibitorsHypothyroidismOverall survival
spellingShingle Wenwen Gong
Erhan Zheng
Minchao Liu
Yaliang Han
Zhaohui Lyu
Qinghua Guo
Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
BMC Endocrine Disorders
Thyroid irAEs
Risk factors
Malignant solid tumor
PD-1/PD-L1 inhibitors
Hypothyroidism
Overall survival
title Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
title_full Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
title_fullStr Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
title_full_unstemmed Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
title_short Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center
title_sort risk factors and outcomes of thyroid immune related adverse events following pd 1 pd l1 inhibitors treatment in a large tertiary chinese center
topic Thyroid irAEs
Risk factors
Malignant solid tumor
PD-1/PD-L1 inhibitors
Hypothyroidism
Overall survival
url https://doi.org/10.1186/s12902-025-01986-1
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