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Section of Endocrinology, Department of Endocrinology and Metabolism (F.P., E.M., R.E., C.Ce., A.P.), University of Pisa, 43-56126 Pisa, Italy; Section of Endocrinology, Department of Internal Medicine, Endocrinology, and Metabolism (F.P.), University of Siena, 46-53100 Siena, Italy; Divisions of Endocrinology and Metabolism (P.W.L., R.L.W.) and Nuclear Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205; Service de Medicine Nucleaire et de Cancerologie Endocrinienne (M.S., S.L., M.R.), Institut Gustave Roussy, 94805 Villejuif, France; Department of Nuclear Medicine (A.D.), London Health Sciences Centre, London, Ontario, Canada N6A 5W9; Klinik und Poliklinik fur Nuklearmedizin (M.Lu., H.H., R.F., M.La., C.R.), Universitat Würzburg, 97070 Würzburg, Germany; Departments of Internal Medicine and Radiology (R.T.K.), Divisions of Endocrinology and Nuclear Medicine, The Ohio State University, Columbus, Ohio 43210; Departments of Endocrine Neoplasia and Hormonal Disorders (S.S., N.L.B.) and Nuclear Medicine (E.D.), University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; Division of Endocrinology (B.H.), University of Colorado Health Sciences Center, Aurora, Colorado 80045; Service de Médecine Nucléaire (C.Co.), Centre René Huguenin, 92210 Saint Cloud, France; and Department of Otolaryngology-Head and Neck Surgery (J.Y.), University of Western Ontario, London, Ontario, Canada N6A 5B8
Address all correspondence and requests for reprints to: F. Pacini, Section of Endocrinology, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.
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 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 human 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 ablation. After the administration of the 131-I dose, the rate of radiation clearance from blood, thyroid remnant, and whole body was 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 their significantly higher Short Form-36 Health Assessment Scale scores in five of eight 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. rhTSH-prepared patients maintained a higher quality of life and received less radiation exposure to the blood.
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