Long-term efficacy of modified-release recombinant human thyrotropin augmented radioiodine therapy for benign multinodular goiter: Results from a multicenter, international, randomized, placebo-controlled, dose-selection study

Thyroid

Volumn 24, Issue 4, 2014, Pages 727-735

  Fast, Søren ^a   Hegedüs, Laszlo ^a   Pacini, Furio ^b   Pinchera, Aldo ^c   Leung, Angela M ^d   Vaisman, Mario ^e   Reiners, Christoph ^f   Wemeau, Jean Louis ^g   Huysmans, Dyde A ^h   Harper, William ⁱ   Rachinsky, Irina ^j   De Souza, Hevelyn Noemberg ^k   Castagna, Maria G ^b   Antonangeli, Lucia ^c   Braverman, Lewis E ^d   Corbo, Rossana ^e   Düren, Christian ^f   Proust Lemoine, Emmanuelle ^g   Marriott, Christopher ⁱ   Driedger, Albert ^j   Grupe, Peter ^a   Watt, Torquil ^l   Magner, James ^m   Purvis, Annie ^m   Graf, Hans ^k   more..

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b UNIVERSITY OF SIENA   (Italy)

^c UNIVERSITY HOSPITAL OF PISA   (Italy)

^d BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^f UNIVERSITY OF WÜRZBURG   (Germany)

^g LILLE UNIVERSITY HOSPITAL   (France)

^h CATHARINA HOSPITAL   (Netherlands)

ⁱ HAMILTON GENERAL HOSPITAL   (Canada)

^j LONDON HEALTH SCIENCES CENTRE   (Canada)

^k FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

^l Rigshospitalet   (Denmark)

^m GENZYME CORPORATION   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IODINE 131; PLACEBO; RECOMBINANT THYROTROPIN; DELAYED RELEASE FORMULATION; RADIOACTIVE IODINE; RECOMBINANT PROTEIN;

ADULT; ARTICLE; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; COUGHING; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HEADACHE; HUMAN; HYPERTENSION; HYPERTHYROIDISM; INFLUENZA; LIMB PAIN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTINODULAR GOITER; NAUSEA; NECK PAIN; NODULAR GOITER; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; THYROID FUNCTION; THYROID WEIGHT; ADJUVANT CHEMOTHERAPY; AGED; CLINICAL TRIAL; DELAYED RELEASE FORMULATION; DRUG EFFECTS; GOITER, NODULAR; MIDDLE AGED; ORGAN SIZE; PATHOLOGY; RADIATION RESPONSE; THYROID FUNCTION TEST; TREATMENT OUTCOME;

AGED; CHEMOTHERAPY, ADJUVANT; DELAYED-ACTION PREPARATIONS; FEMALE; GOITER, NODULAR; HUMANS; IODINE RADIOISOTOPES; MALE; MIDDLE AGED; ORGAN SIZE; RECOMBINANT PROTEINS; SINGLE-BLIND METHOD; THYROID FUNCTION TESTS; THYROTROPIN ALFA; TREATMENT OUTCOME;

EID: 84898473987     PISSN: 10507256     EISSN: 15579077     Source Type: Journal    
DOI: 10.1089/thy.2013.0370     Document Type: Article

References (33)

1. Fast S, Nielsen VE, Bonnema SJ, Hegedus L 2009 Time to reconsider nonsurgical therapy of benign non-toxic multinodular goitre: Focus on recombinant human TSH augmented radioiodine therapy. Eur J Endocrinol 160:517-528
2. Paschke R, Hegedus L, Alexander E, Valcavi R, Papini E, Gharib H 2011 Thyroid nodule guidelines: Agreement, disagreement and need for future research. Nat Rev Endocrinol 7:354-361
3. Bonnema SJ, Hegedus L 2012 Radioiodine therapy in benign thyroid diseases: Effects, side effects, and factors affecting therapeutic outcome. Endocr Rev 33:920-980
4. Hegedus L, Bonnema SJ, Bennedbaek FN 2003 Management of simple nodular goiter: Current status and future perspectives. Endocr Rev 24:102-132
5. Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Vitti P 2010 American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. Endocr Pract 16:1-43
6. Fast S, Nielsen VE, Grupe P, Bonnema SJ, Hegedus L 2009 Optimizing 131I uptake after rhTSH stimulation in patients with nontoxic multinodular goiter: Evidence from a prospective, randomized, double-blind study. J Nucl Med 50:732-737
7. Huysmans DA, Nieuwlaat WA, Erdtsieck RJ, Schellekens AP, Bus JW, Bravenboer B, Hermus AR 2000 Administration of a single low dose of recombinant human thyrotropin significantly enhances thyroid radioiodide uptake in nontoxic nodular goiter. J Clin Endocrinol Metab 85:3592-3596
8. Nieuwlaat WA, Huysmans DA, van den Bosch HC, Sweep CG, Ross HA, Corstens FH, Hermus AR 2003 Pretreatment with a single, low dose of recombinant human thyrotropin allows dose reduction of radioiodine therapy in patients with nodular goiter. J Clin Endocrinol Metab 88:3121-3129
9. Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Veje A, Hegedus L 2005 Recombinant human thyrotropin markedly changes the 131I kinetics during 131I therapy of patients with nodular goiter: An evaluation by a randomized doubleblinded trial. J Clin Endocrinol Metab 90:79-83
10. Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Grupe P, Hegedus L 2006 Stimulation with 0.3-mg recombinant human thyrotropin prior to iodine 131 therapy to improve the size reduction of benign nontoxic nodular goiter: A prospective randomized double-blind trial. Arch Intern Med 166:1476-1482
11. Bonnema SJ, Nielsen VE, Boel-Jorgensen H, Grupe P, Andersen PB, Bastholt L, Hegedus L 2007 Improvement of goiter volume reduction after 0.3 mg recombinant human thyrotropin-stimulated radioiodine therapy in patients with a very large goiter: A double-blinded, randomized trial. J Clin Endocrinol Metab 92:3424-3428
12. Silva MN, Rubio IG, Romao R, Gebrin EM, Buchpiguel C, Tomimori E, Camargo R, Cardia MS, Medeiros-Neto G 2004 Administration of a single dose of recombinant human thyrotrophin enhances the efficacy of radioiodine treatment of large compressive multinodular goitres. Clin Endocrinol (Oxf) 60:300-308
13. Albino CC, Graf H, Paz-Filho G, Diehl LA, Olandoski M, Sabbag A, Buchpiguel C 2010 Radioiodine plus recombinant human thyrotropin do not cause acute airway compression and are effective in reducing multinodular goiter. Braz J Med Biol Res 43:303-309
14. Graf H, Fast S, Pacini F, Pinchera A, Leung A, Vaisman M, Reiners C, Wemeau JL, Huysmans D, Harper W, Driedger A, de SouzaHN, CastagnaMG, Antonangeli L, Braverman L, Corbo R, Duren C, Proust-Lemoine E, Edelbroek MA, Marriott C, Rachinsky I, Grupe P, Watt T, Magner J, Hegedus L 2011 Modified-release recombinant human TSH (MRrhTSH) augments the effect of (131)I therapy in benign multinodular goiter: Results from a multicenter international, randomized, placebo-controlled study. J Clin Endocrinol Metab 96:1368-1376
15. Watt T, Hegedus L, Groenvold M, Bjorner JB, Rasmussen AK, Bonnema SJ, Feldt-Rasmussen U 2010 Validity and reliability of the novel thyroid-specific quality of life questionnaire, ThyPRO. Eur J Endocrinol 162:161-167
16. LeMoli R, Wesche MF, Tiel-Van Buul MM, Wiersinga WM 1999 Determinants of longterm outcome of radioiodine therapy of sporadic non-toxic goitre. Clin Endocrinol (Oxf) 50:783-789
17. Nygaard B, Hegedus L, Gervil M, Hjalgrim H, Soe-Jensen P, Hansen JM 1993 Radioiodine treatment of multinodular non-toxic goitre. Br Med J 307:828-832
18. Fast S, Nielsen VE, Grupe P, Boel-Jorgensen H, Bastholt L, Andersen PB, Bonnema SJ, Hegedus L 2012 Prestimulation with recombinant human thyrotropin (rhTSH) improves the long-term outcome of radioiodine therapy for multinodular nontoxic goiter. J Clin Endocrinol Metab 97:2653-2660
19. Cardia MS, Rubio IG, Medeiros-Neto G 2006 Prolonged follow-up of multinodular goitre patients treated with radioiodine preceded or not by human recombinant TSH. Clin Endocrinol (Oxf) 64:474
20. Giusti M, Caputo M, Calamia I, Bagnara M, Ceresola E, Schiavo M, Mussap M, Ferone D, Minuto F, Bagnasco M 2009 Long-term outcome of low-activity radioiodine administration preceded by adjuvant recombinant human TSH pretreatment in elderly subjects with multinodular goiter. Thyroid Res 2:6
21. Bonnema SJ, Bertelsen H, Mortensen J, Andersen PB, Knudsen DU, Bastholt L, Hegedus L 1999 The feasibility of high dose iodine 131 treatment as an alternative to surgery in patients with a very large goiter: Effect on thyroid function and size and pulmonary function. J Clin Endocrinol Metab 84:3636-3641
22. Bonnema SJ, Nielsen VE, Boel-Jorgensen H, Grupe P, Andersen PB, Bastholt L, Hegedus L 2008 Recombinant human thyrotropin-stimulated radioiodine therapy of large nodular goiters facilitates tracheal decompression and improves inspiration. J Clin Endocrinol Metab 93:3981-3984
23. Cubas ER, Paz-Filho GJ, Olandoski M, Goedert CA, Woellner LC, Carvalho GA, Graf H 2009 Recombinant human TSH increases the efficacy of a fixed activity of radioiodine for treatment of multinodular goitre. Int J Clin Pract 63:583-590
24. de Klerk JM, van Isselt JW, van DA, Hakman ME, Pameijer FA, Koppeschaar HP, Zelissen PM, van Schaik JP, van Rijk PP 1997 Iodine-131 therapy in sporadic nontoxic goiter. J Nucl Med 38:372-376
25. Fast S, Nielsen VE, Bonnema SJ, Hegedus L 2009 Time to reconsider nonsurgical therapy of benign non-toxic multinodular goitre: Focus on recombinant human TSH augmented radioiodine therapy. Eur J Endocrinol 160:517-528
26. Fast S, Bonnema SJ, Hegedus L 2011 Radioiodine therapy of benign non-toxic goitre. Potential role of recombinant human TSH. Ann Endocrinol (Paris) 72:129-135
27. Braverman L, Kloos RT, Law B, Jr., Kipnes M, Dionne M, Magner J 2008 Evaluation of various doses of recombinant human thyrotropin in patients with multinodular goiters. Endocr Pract 14:832-839
28. Fast S, Hegedus L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ 2010 Recombinant human thyrotropin- stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab 95:3719-3725
29. Barca MF, Gruppi C, Oliveira MT, Romao R, Cardia MS, Rubio I, Knobel M, Medeiros-Neto G 2007 Cardiovascular assessment of hyperthyroid patients with multinodular goiter before and after radioiodine treatment preceded by stimulation with recombinant human TSH. Endocrine 32:175-181
30. Torres MS, Ramirez L, Simkin PH, Braverman LE, Emerson CH 2001 Effect of various doses of recombinant human thyrotropin on the thyroid radioactive iodine uptake and serum levels of thyroid hormones and thyroglobulin in normal subjects. J Clin Endocrinol Metab 86:1660-1664
31. Fast S, Nielsen VE, Bonnema SJ, Hegedus L 2010 Dosedependent acute effects of recombinant human TSH (rhTSH) on thyroid size and function: Comparison of 0.1, 0.3 and 0.9mg of rhTSH. Clin Endocrinol (Oxf) 72:411-416
32. Hegedus L, Hansen BM, Knudsen N, Hansen JM 1988 Reduction of size of thyroid with radioactive iodine in multinodular non-toxic goitre. Br Med J 297:661-662
33. Lawrence JE, Emerson CH, Sullaway SL, Braverman LE 2001 The effect of recombinant human tsh on the thyroid (123)i uptake in iodide treated normal subjects. J Clin Endocrinol Metab 86:437-440.