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PD-1/PD-L1抑制剂致肺癌患者甲状腺功能异常的临床特征及其疗效预测价值

Clinical Features of PD-1/PD-L1 Inhibitors-Related Thyroid Dysfunction in Lung Cancer Patients and Their Predictive Value for Therapeutic Efficacy

    摘要
  • 摘要:
    目的 探讨肺癌患者在接受程序性死亡受体-1（programmed cell death receptor-1, PD-1）以及程序性死亡受体-配体1（programmed cell death receptor-ligand 1, PD-L1）治疗后出现甲状腺功能异常的临床特征及其疗效预测价值。
    方法 回顾性纳入2018年3月–2022年9月在四川大学华西医院接受PD-1/PD-L1抑制剂治疗的肺癌患者，收集其病历信息、治疗效果以及甲状腺功能指标等数据，分析发生甲状腺免疫相关不良反应（immune-related adverse events, irAEs）的危险因素和预测因素，分析发生甲状腺irAE对疗效的预测价值和对预后的影响。疗效指标为客观缓解率（objective response rate, ORR），预后指标为无进展生存期（progression-free survival, PFS）。
    结果 共纳入368例肺癌患者，有31.5%（116/368）的患者出现甲状腺irAE。logistic回归分析结果显示，用药前（基线）促甲状腺激素（thyroid stimulating hormone, TSH）浓度、甲状腺过氧化物酶抗体（thyroid peroxidase antibody, TPOAb）和甲状腺球蛋白抗体（thyroglobulin antibody, TGAb）阳性是PD-1/PD-L1抑制剂导致甲状腺irAE的危险因素，其中基线TPOAb浓度具有较好的预测甲状腺irAE的价值，受试者工作特征（receiver-operating characteristic, ROC）曲线下面积（area under the curve, AUC）为0.745。甲状腺irAE组患者相比于未发生甲状腺irAE组患者的中位PFS延长（16.0个月 vs. 9.7个月，P<0.001），且甲状腺irAE组的ORR高于未发生甲状腺irAE组（55.2% vs. 34.9%，P<0.001），发生甲状腺irAE的患者较未发生甲状腺irAE的患者更易出现客观缓解〔优势比（odds ratio, OR）=2.29，95%置信区间（confidence interval, CI）：1.46～3.60〕。
    结论 肺癌患者接受PD-1/PD-L1抑制剂治疗后，自身抗体TPOAb对甲状腺irAE具有较好的预测价值。发生甲状腺irAE者的疗效和生存预后更佳。

     

    Abstract:
    Objective To investigate the clinical features of thyroid dysfunction in lung cancer patients treated with programmed cell death receptor-1 (PD-1) or programmed cell death receptor-ligand 1 (PD-L1) and their value for predicting therapeutic efficacy.
    Methods Lung cancer patients treated with PD-1/PD-L1 inhibitors at West China Hospital, Sichuan University between March 2018 and September 2022 were retrospectively enrolled. Data concerning the medical records, therapeutic efficacy, and thyroid function indicators of the patients were retrieved from the hospital electronic medical record information system. The data were then analyzed to identify risk factors and predictive factors for immune-related adverse events (irAEs) of the thyroid. The predictive value of thyroid irAEs for treatment efficacy and prognosis was assessed. Objective response rate (ORR) was defined as the indicator for therapeutic efficacy and progression-free survival (PFS) was defined as the prognostic indicator.
    Results A total of 368 lung cancer patients were enrolled. Among them, 31.5% (116/368) developed thyroid irAEs. According to the results of logistic regression analysis, baseline thyroid stimulating hormone (TSH) concentration and baseline positive results for thyroglobulin antibody (TGAb) and thyroid peroxidase antibody (TPOAb) were risk factors for thyroid dysfunction caused by PD-1/PD-L1 inhibitors. Among the three measures, baseline TPOAb concentration demonstrated good predictive value for thyroid irAEs, with an area under the receiver-operating characteristic (ROC) curve (AUC) of 0.745. Patients with thyroid irAEs had a longer median PFS (16.0 months vs. 9.7 months, P < 0.001) and a higher ORR (55.2% vs. 34.9%, P < 0.001) compared to those without thyroid irAEs. Patients with thyroid irAEs had a better ORR than those without thyroid irAEs did. It was more likely for patients with thyroid irAEs to achieve an objective response compared to those without thyroid irAEs (odds ratio OR = 2.29; 95% CI, 1.46-3.60).
    Conclusion In lung cancer patients treated with the PD-1/PD-L1 inhibitors, the TPOAb antibody demonstrates good predictive value for thyroid irAEs. Patients who develop thyroid irAEs have better treatment outcomes and prognosis.

     

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