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低风险和中风险甲状腺癌随访的数据驱动甲状腺球蛋白临界值:ITCO真实世界分析

Data-driven Thyroglobulin Cutoffs for Low- and Intermediate-risk Thyroid Cancer Follow-up: ITCO Real-world Analysis.

作者信息

Grani Giorgio, D'Elia Silvia, Puxeddu Efisio, Morelli Silvia, Arvat Emanuela, Nervo Alice, Spiazzi Giovanna, Rolli Nicoletta, Zatelli Maria Chiara, Ambrosio Maria Rosaria, Ceresini Graziano, Marina Michela, Mele Chiara, Aimaretti Gianluca, Santaguida Maria Giulia, Virili Camilla, Crescenzi Anna, Palermo Andrea, Rossetto Giaccherino Ruth, Meomartino Letizia, Castagna Maria Grazia, Maino Fabio, Trevisan Matteo, De Leo Simone, Chiofalo Maria Grazia, Pezzullo Luciano, Sparano Clotilde, Petrone Luisa, Di Dalmazi Giulia, Napolitano Giorgio, Tumino Dario, Crocetti Umberto, Bertagna Francesco, Deandrea Maurilio, Antonelli Alessandro, Mian Caterina, Carbone Antonella, Monti Salvatore, Porcelli Tommaso, Brigante Giulia, Barbaro Daniele, Alfò Marco, Ferraro Petrillo Umberto, Filetti Sebastiano, Durante Cosimo

机构信息

Department of Translational and Precision Medicine, Sapienza University of Rome, 00161 Rome, Italy.

Department of Statistical Sciences, Sapienza University of Rome, 00185 Rome, Italy.

出版信息

J Clin Endocrinol Metab. 2025 Apr 22;110(5):e1377-e1384. doi: 10.1210/clinem/dgae559.

Abstract

CONTEXT

The utility of thyroglobulin (Tg) in the follow-up of patients with differentiated thyroid cancer has been well-documented. Although third-generation immunoassays have improved accuracy, limitations persist (interfering anti-Tg antibodies and measurement variability). Evolving treatment strategies require a reevaluation of Tg thresholds for optimal patient management.

OBJECTIVE

To assess the performance of serum Tg testing in 2 populations: patients receiving total thyroidectomy and radioiodine remnant ablation (RRA) or treated with thyroidectomy alone.

DESIGN

Prospective observational study.

SETTING

Centers contributing to the Italian Thyroid Cancer Observatory database.

PATIENTS

We included 540 patients with 5 years of follow-up and negative anti-Tg antibodies.

INTERVENTIONS

Serum Tg levels assessed at 1-year follow-up visit.

MAIN OUTCOME MEASURE

Detection of structural disease within 5 years of follow-up.

RESULTS

After excluding 26 patients with structural disease detected at any time point, the median Tg did not differ between patients treated with or without radioiodine. Data-driven Tg thresholds were established based on the 97th percentile of Tg levels in disease-free individuals: 1.97 ng/mL for patients undergoing thyroidectomy alone (lower than proposed by the Memorial Sloan Kettering Cancer Center protocol and ESMO Guidelines, yet demonstrating good predictive ability, with a negative predictive value of 98% and 0.84 ng/mL for patients receiving postsurgical RRA. High sensitivity and negative predictive value supported the potential of these thresholds in excluding structural disease.

CONCLUSION

This real-world study provides evidence for the continued reliability of 1-year serum Tg levels. The data-driven Tg thresholds proposed offer valuable insights for clinical decision-making in patients undergoing total thyroidectomy with or without RRA.

摘要

背景

甲状腺球蛋白(Tg)在分化型甲状腺癌患者随访中的作用已有充分记录。尽管第三代免疫测定法提高了准确性,但局限性仍然存在(干扰性抗Tg抗体和测量变异性)。不断发展的治疗策略需要重新评估Tg阈值以实现最佳患者管理。

目的

评估血清Tg检测在两组人群中的表现:接受全甲状腺切除术和放射性碘残留消融(RRA)的患者或仅接受甲状腺切除术治疗的患者。

设计

前瞻性观察性研究。

设置

为意大利甲状腺癌观察站数据库提供数据的中心。

患者

我们纳入了540例有5年随访且抗Tg抗体阴性的患者。

干预措施

在1年随访时评估血清Tg水平。

主要观察指标

随访5年内结构疾病的检测情况。

结果

排除在任何时间点检测到有结构疾病的26例患者后,接受或未接受放射性碘治疗的患者的中位Tg无差异。基于无病个体中Tg水平的第97百分位数建立了数据驱动的Tg阈值:仅接受甲状腺切除术的患者为1.97 ng/mL(低于纪念斯隆凯特琳癌症中心方案和ESMO指南提出的值,但显示出良好的预测能力,阴性预测值为98%),接受术后RRA的患者为0.84 ng/mL。高敏感性和阴性预测值支持这些阈值在排除结构疾病方面的潜力。

结论

这项真实世界研究为1年血清Tg水平的持续可靠性提供了证据。提出的数据驱动的Tg阈值为接受或未接受RRA的全甲状腺切除术患者的临床决策提供了有价值的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6453/12012673/24fe6e41bf6b/dgae559f1.jpg

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