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Submitted on July 26, 2005
Accepted on December 20, 2005
Section of Endocrinology, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy; Section of Endocrinology, Department of Internal Medicine, Endocrinology and Metabolism, University of Siena, Italy; Division of Endocrinology and Metabolism, and Division of Nuclear Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Service de Medicine Nucleaire et de Cancerologie Endocrinienne, Institut Gustave Roussy, Villejuif, France; Department of Nuclear Medicine, London Health Sciences Centre, London, Ont, Canada; Klinik und Poliklinik fur Nuklearmedizin, Universitat Würzburg, Würzburg, Germany; Departments of Internal Medicine and Radiology, Divisions of Endocrinology and Nuclear Medicine, The Ohio State University, Columbus, OH, USA; Department of Endocrine Neoplasia and Hormonal Disorders (S.S., N.L.B.); Department of Nuclear Medicine (E.D.), University of Texas M.D. Anderson Cancer Center, Houston, TX, USA; University of Colorado Health Sciences Center, Division of Endocrinology, Aurora, CO, USA; Service de Médecine Nucléaire, Centre René Huguenin, Saint Cloud, France; Department of Otolaryngology-Head and Neck Surgery, University of Western Ontario, London, ONT, Canada
Context: After surgery for differentiated thyroid carcinoma, many patients are treated with radioiodine to ablate remnant thyroid tissue. This procedure has been performed with the patient in the hypothyroid state to promote endogenous TSH (TSH) stimulation, and is often associated with hypothyroid symptoms and impaired quality of life.
Objective and Intervention: This international, randomized, controlled, multicenter trial aimed to compare the efficacy and safety of recombinant TSH (rhTSH) to prepare euthyroid patients on L-thyroxine therapy (Euthyroid Group) to ablate remnant thyroid tissue with 3.7 GBq (100 mCi) 131I compared with that with conventional remnant ablation performed in the hypothyroid state (Hypothyroid Group). Quality of life was determined at the time of randomization and at the time of ablation. Following the administration of 131-I dose, the rate of radiation clearance from blood, thyroid remnant, and whole body were measured.
Results: The predefined primary criterion for successful ablation was "no visible uptake in the thyroid bed, or if visible, fractional uptake less than 0.1%" on neck scans performed 8 months after therapy, and was satisfied in 100% of patients in both groups. A secondary criterion for ablation, an rhTSH-stimulated serum thyroglobulin concentration less than 2 ng/ml, was fulfilled by 23 of 24 (96%) Euthyroid patients and 18 of 21 (86%) Hypothyroid patients (P = 0.2341). Quality of life was well preserved in the Euthyroid group compared with the Hypothyroid group, as demonstrated by their lower pretreatment scores on the Billewicz scale for hypothyroid signs and symptoms, 27 ± 7 vs. 18 ± 4 (P < 0.0001), and by their significantly higher SF-36 Health Assessment Scale scores in 5 of 8 categories. Euthyroid patients had a statistically significant one-third lower radiation dose to the blood compared with patients in the Hypothyroid group.
Conclusions: This study demonstrates comparable remnant ablation rates in patients prepared for 131I remnant ablation with 3.7 GBq by either administering rhTSH or withholding thyroid hormone. Recombinant human TSH-prepared patients maintained a higher quality of life, and received less radiation exposure to the blood.
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