低风险和中风险甲状腺癌随访的数据驱动的甲状腺球蛋白截止值：ITCO 真实世界分析。
Data-Driven Thyroglobulin Cutoffs for Low- and Intermediate-Risk Thyroid Cancer Follow-Up: ITCO Real-World Analysis.
发表日期：2024 Aug 16
作者：
Giorgio Grani, Silvia D'Elia, Efisio Puxeddu, Silvia Morelli, Emanuela Arvat, Alice Nervo, Giovanna Spiazzi, Nicoletta Rolli, Maria Chiara Zatelli, Maria Rosaria Ambrosio, Graziano Ceresini, Michela Marina, Chiara Mele, Gianluca Aimaretti, Maria Giulia Santaguida, Camilla Virili, Anna Crescenzi, Andrea Palermo, Ruth Rossetto Giaccherino, Letizia Meomartino, Maria Grazia Castagna, Fabio Maino, Matteo Trevisan, Simone De Leo, Maria Grazia Chiofalo, Luciano Pezzullo, Clotilde Sparano, Luisa Petrone, Giulia Di Dalmazi, Giorgio Napolitano, Dario Tumino, Umberto Crocetti, Francesco Bertagna, Maurilio Deandrea, Alessandro Antonelli, Caterina Mian, Antonella Carbone, Salvatore Monti, Tommaso Porcelli, Giulia Brigante, Daniele Barbaro, Marco Alfò, Umberto Ferraro Petrillo, Sebastiano Filetti, Cosimo Durante
来源：
DIABETES & METABOLISM
摘要：
甲状腺球蛋白 (Tg) 在分化型甲状腺癌 (DTC) 患者随访中的效用已有充分记录。尽管第三代免疫测定的准确性有所提高，但局限性仍然存在（干扰抗 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。评估血清 Tg 检测在两个人群中的表现：接受甲状腺全切除术和放射性碘残余消融 (RRA) 的患者，或仅接受甲状腺切除术治疗的患者。前瞻性观察研究。环境。为意大利甲状腺癌观察站 (ITCO) 数据库提供数据的中心。我们纳入了 540 名经过 5 年随访且抗 Tg 抗体呈阴性的患者。在 1 年随访时评估血清 Tg 水平。5 年内检测到结构性疾病随访数年。排除任意时间点检测到的 26 名结构性疾病患者后，接受或不接受放射性碘治疗的患者之间的中位 Tg 没有差异。数据驱动的 Tg 阈值是根据无病个体 Tg 水平的第 97 个百分位数建立的：仅接受甲状腺切除术的患者为 1.97 ng/mL（低于 MSKCC 方案和 ESMO 指南提出的水平，但表现出良好的预测能力，具有良好的预测能力）对于接受术后 RRA 的患者，阴性预测值 (NPV) 为 98%）和 0.84 ng/mL。高灵敏度和 NPV 支持这些阈值在排除结构性疾病方面的潜力。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 Tg 阈值为接受甲状腺全切除术（伴或不伴 RRA）的患者的临床决策提供了宝贵的见解。© 作者 2024。由牛津大学出版社代表内分泌学会出版。
The utility of thyroglobulin (Tg) in the follow-up of differentiated thyroid cancer (DTC) patients 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.To assess the performance of serum Tg testing in two populations: patients receiving total thyroidectomy and radioiodine remnant ablation (RRA), or treated with thyroidectomy alone.Prospective observational study. Setting. Centers contributing to the Italian Thyroid Cancer Observatory (ITCO) database.We included 540 patients with 5 years of follow-up and negative anti-Tg antibodies.Serum Tg levels assessed at 1-year follow-up visit.Detection of structural disease within 5 years of follow-up.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 MSKCC protocol and ESMO Guidelines, yet demonstrating good predictive ability, with a negative predictive value (NPV) of 98%) and 0.84 ng/mL for patients receiving post-surgical RRA. High sensitivity and NPV supported the potential of these thresholds in excluding structural disease.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.© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.