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

Author:

Grani Giorgio1ORCID,D’Elia Silvia2,Puxeddu Efisio3,Morelli Silvia3,Arvat Emanuela4ORCID,Nervo Alice4,Spiazzi Giovanna5,Rolli Nicoletta5,Zatelli Maria Chiara6ORCID,Ambrosio Maria Rosaria6,Ceresini Graziano7,Marina Michela7,Mele Chiara8,Aimaretti Gianluca8,Santaguida Maria Giulia9,Virili Camilla9,Crescenzi Anna1011,Palermo Andrea12ORCID,Rossetto Giaccherino Ruth13,Meomartino Letizia13,Castagna Maria Grazia14ORCID,Maino Fabio14ORCID,Trevisan Matteo15,De Leo Simone15,Chiofalo Maria Grazia16,Pezzullo Luciano16,Sparano Clotilde17ORCID,Petrone Luisa17ORCID,Di Dalmazi Giulia18,Napolitano Giorgio18,Tumino Dario19,Crocetti Umberto20,Bertagna Francesco21,Deandrea Maurilio22,Antonelli Alessandro23,Mian Caterina24ORCID,Carbone Antonella25,Monti Salvatore26,Porcelli Tommaso27,Brigante Giulia2829ORCID,Barbaro Daniele30,Alfò Marco2,Ferraro Petrillo Umberto2ORCID,Filetti Sebastiano1ORCID,Durante Cosimo1ORCID

Affiliation:

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

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

3. Department of Medicine and Surgery, University of Perugia , 06129 Perugia , Italy

4. Oncological Endocrinology Unit, Department of Medical Sciences, Città della Salute e della Scienza Hospital, University of Turin , 10126 Turin , Italy

5. Endocrinology and Diabetology Unit, Department of Medicine, Azienda Ospedaliera-Universitaria di Verona , 37126 Verona , Italy

6. Section of Endocrinology, Geriatrics and Internal Medicine, Department of Medical Sciences, University of Ferrara , 44121 Ferrara , Italy

7. Unit of Internal Medicine and Oncological Endocrinology, University Hospital of Parma , 43126 Parma , Italy

8. Endocrinology, Department of Translational Medicine, University of Piemonte Orientale , 28100 Novara , Italy

9. Endocrinology Unit, Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome , 04100 Latina , Italy

10. Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome , 00161 Rome , Italy

11. Unit of Endocrine Organs and Neuromuscolar Pathology, Fondazione Policlinico Universitario Campus Bio-Medico , 00128 Rome , Italy

12. Unit of Metabolic Bone and Thyroid Diseases, Fondazione Policlinico Universitario Campus Bio-Medico , 00128 Rome , Italy

13. Endocrinology, Diabetology and Metabolism, Department of Medical Sciences, University of Turin , 10126 Turin , Italy

14. Department of Medicine, Surgery and Neuroscience, Section of Endocrinology, University of Siena , 53100 Siena , Italy

15. Endocrine Oncology Unit, Department of Endocrine and Metabolic Diseases, IRCCS Istituto Auxologico Italiano , 20095 Milan , Italy

16. IRCCS Fondazione G. Pascale, National Cancer Institute , 80131 Naples , Italy

17. Endocrinology Unit, Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence , 50134 Florence , Italy

18. Department of Medicine and Aging Sciences, University “G. d'Annunzio” of Chieti-Pescara , 66100 Chieti , Italy

19. Department of Clinical and Experimental Medicine, University of Catania , 95122 Catania , Italy

20. Department of Medical Sciences, Hospital “Casa Sollievo della Sofferenza”, IRCCS , 71013 San Giovanni Rotondo , Italy

21. Nuclear Medicine, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia and Spedali Civili di Brescia , 25123 Brescia , Italy

22. UO Endocrinologia, Diabetologia e Malattie del metabolismo, AO Ordine Mauriziano Torino , 10128 Torino , Italy

23. Department of Surgery, Medical and Molecular Pathology and Critical Area, University of Pisa , 56100 Pisa , Italy

24. Operative Unit of Endocrinology Department of Medicine-DIMED University of Padua , 35128 Padua , Italy

25. Endocrine Unit, Tinchi Hospital, Asm Matera , 75015 Matera , Italy

26. Endocrinology and Diabetes Unit, Azienda Ospedaliero-Universitaria Sant’Andrea, Sapienza University of Rome , 00189 Rome , Italy

27. Department of Public Health, University of Naples “Federico II” , 80131 Naples , Italy

28. Unit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia , 41125 Modena , Italy

29. Unit of Endocrinology, Department of Medical Specialties, Azienda Ospedaliero-Universitaria of Modena , 41124 Modena , Italy

30. Unit of Endocrinology ASL North West Tuscany , Ospedali Riuniti, 57124 Livorno , Italy

Abstract

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.

Publisher

The Endocrine Society

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