title: Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study.
abstract: BACKGROUND
  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.
authors.affiliation: Section of Endocrinology, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Pacini
authors.forename: P W
authors.initials: PW
authors.lastname: Ladenson
authors.forename: M
authors.initials: M
authors.lastname: Schlumberger
authors.forename: A
authors.initials: A
authors.lastname: Driedger
authors.forename: M
authors.initials: M
authors.lastname: Luster
authors.forename: R T
authors.initials: RT
authors.lastname: Kloos
authors.forename: S
authors.initials: S
authors.lastname: Sherman
authors.forename: B
authors.initials: B
authors.lastname: Haugen
authors.forename: C
authors.initials: C
authors.lastname: Corone
authors.forename: E
authors.initials: E
authors.lastname: Molinaro
authors.forename: R
authors.initials: R
authors.lastname: Elisei
authors.forename: C
authors.initials: C
authors.lastname: Ceccarelli
authors.forename: A
authors.initials: A
authors.lastname: Pinchera
authors.forename: R L
authors.initials: RL
authors.lastname: Wahl
authors.forename: S
authors.initials: S
authors.lastname: Leboulleux
authors.forename: M
authors.initials: M
authors.lastname: Ricard
authors.forename: J
authors.initials: J
authors.lastname: Yoo
authors.forename: N L
authors.initials: NL
authors.lastname: Busaidy
authors.forename: E
authors.initials: E
authors.lastname: Delpassand
authors.forename: H
authors.initials: H
authors.lastname: Hanscheid
authors.forename: R
authors.initials: R
authors.lastname: Felbinger
authors.forename: M
authors.initials: M
authors.lastname: Lassmann
authors.forename: C
authors.initials: C
authors.lastname: Reiners
mesh_terms: D000293:Adolescent; D000328:Adult; D002277:Carcinoma / Q000473:pathology / Q000532:radiotherapy / Q000534:rehabilitation; D005260:Female; D006801:Humans; D007457:Iodine Radioisotopes / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D013964:Thyroid Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000534:rehabilitation; D013972:Thyrotropin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes; D011994:Recombinant Proteins; D013972:Thyrotropin