Department of Endocrinology, Qilu Hospital, Shandong University, Ji-Nan, China.
Department of Medical Oncology, Qilu Hospital, Shandong University, Ji-Nan, China.
J Cancer Res Clin Oncol. 2023 Dec;149(18):16501-16510. doi: 10.1007/s00432-023-05364-z. Epub 2023 Sep 15.
Thyroid dysfunction is the most common immune-related adverse event during anti-programmed cell death 1 (anti-PD-1) therapy. In this study, we monitored patients with advanced malignant tumors who received anti-PD-1 therapy to observe the characteristic of anti-PD-1 therapy-induced thyroid dysfunction and its correlation with prognosis.
Patients with advanced carcinoma treated with anti-PD-1 therapy were evaluated for thyroid function at baseline and after treatment initiation from August 2020 to March 2022. Seventy-three patients were finally included in the study.
Among these patients, 19 (26.03%) developed thyroid dysfunction after receiving anti-PD-1 therapy. Primary hypothyroidism and thyrotoxicosis were the most common clinical manifestation. Anti-PD-1-induced thyroid dysfunction occurred 63 (26-131) days after administration; thyrotoxicosis appeared earlier than primary hypothyroidism. In Kaplan-Meier survival analysis, the progression-free survival (PFS) of the thyroid dysfunction group was better than that of the no thyroid dysfunction group (227 (95% confidence interval (CI) 50.85-403.15) days vs 164 (95% CI 77.76-250.24) days, p = 0.026). Male patients had better PFS than female patients (213 (95% CI 157.74-268.26) days vs 74 (95% CI 41.23-106.77) days, p = 0.031). In cox proportional hazards regression model, anti-PD-1-induced thyroid dysfunction remained an independent predictor of better PFS (hazard ratio (HR) = 0.339(0.136-0.848), p = 0.021).
Thyroid dysfunction is a common immune-related adverse events in advanced cancer patients treated with anti-PD-1 therapy and predicts a better prognosis.
This study was retrospectively registered with Trial ClinicalTrials.gov (NCT05593744) on October 25, 2022.
甲状腺功能障碍是抗程序性细胞死亡 1（抗 PD-1）治疗期间最常见的免疫相关不良事件。在这项研究中，我们监测了接受抗 PD-1 治疗的晚期恶性肿瘤患者，以观察抗 PD-1 治疗引起的甲状腺功能障碍的特征及其与预后的关系。
2020 年 8 月至 2022 年 3 月，对接受抗 PD-1 治疗的晚期癌患者进行甲状腺功能评估。最终有 73 例患者纳入研究。
这些患者中，19 例（26.03%）在接受抗 PD-1 治疗后出现甲状腺功能障碍。原发性甲状腺功能减退症和甲状腺毒症是最常见的临床表现。抗 PD-1 诱导的甲状腺功能障碍发生在给药后 63（26-131）天；甲状腺毒症早于原发性甲状腺功能减退症出现。在 Kaplan-Meier 生存分析中，甲状腺功能障碍组的无进展生存期（PFS）优于无甲状腺功能障碍组（227（95%置信区间（CI）50.85-403.15）天 vs 164（95% CI 77.76-250.24）天，p=0.026）。男性患者的 PFS 优于女性患者（213（95% CI 157.74-268.26）天 vs 74（95% CI 41.23-106.77）天，p=0.031）。在 cox 比例风险回归模型中，抗 PD-1 诱导的甲状腺功能障碍仍然是 PFS 更好的独立预测因素（风险比（HR）=0.339（0.136-0.848），p=0.021）。
甲状腺功能障碍是接受抗 PD-1 治疗的晚期癌症患者常见的免疫相关不良事件，预测预后较好。
本研究于 2022 年 10 月 25 日在 Trial ClinicalTrials.gov（NCT05593744）进行了回顾性注册。
