Exp Clin Endocrinol Diabetes 2010; 118(8): 513-519
DOI: 10.1055/s-0029-1234086
Article

© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

The Use of Thyrogen® in the Treatment of Differentiated Thyroid Carcinoma: An Intraindividual Comparison of Clinical Effects and Implications of Daily Life

C. Dueren1 , M. Dietlein2 , M. Luster3 , F. Plenzig4 , R. Steinke5 , J. Grimm6 , P. Groth7 , W. Eichhorn8 , C. Reiners1
  • 1Department of Nuclear Medicine, University of Wuerzburg, Wuerzburg, Germany
  • 2Department of Nuclear Medicine, University of Cologne, Köln, Germany
  • 3Department of Nuclear Medicine, University of Ulm, Ulm, Germany
  • 4Genzyme GmbH, Neu-Isenburg, Germany
  • 5Center of Nuclear Medicine, Magdeburg, Germany
  • 6Center of Nuclear Medicine, Halle, Germany
  • 7Clinic of Nuclear Medicine, University Rostock, Rostock, Germany
  • 8Department of Nuclear Medicine, University of Mainz, Mainz, Germany
Weitere Informationen

Publikationsverlauf

received 24.02.2009 first decision 12.05.2009

accepted 26.06.2009

Publikationsdatum:
23. Oktober 2009 (online)

Abstract

Aim: Withdrawal of levothyroxine with resultant hypothyroidism is still used in preparation for I-131 diagnostic whole-body scan (DWBS) and thyroglobulin (TG)-measurement in patients afflicted with differentiated thyroid cancer (DTC). Recombinant human thyroid-stimulating hormone (rhTSH) enhances TSH stimulation obviating the clinical and economical consequences of hypothyroidism. Primary aim of this study was an intraindividual comparison of diagnostic follow-up measurements under these two sets of conditions by taking clinical and socio-economic parameters into account. Second aim was to determine a clear patient preference for the one method or the other.

Methods: This non-interventional observational study included patients (n=192 signed informed consent, n=128 protocol compliant patients without need for therapeutic intervention) with DTC first treated by thyroidectomy and radioiodine ablation. Control visits including I-131 DWBS were planned at 3–6 months post-thyroidectomy after a phase (KU 1) of thyroid hormone withdrawal (THW) and again after 6–12 months later in a euthyroid state under exogenous stimulation with rhTSH (KU 2). Study design was open, prospective and multicentric. Data collected consisted of patient information (SF-12® Health Survey), thyroid-specific results of clinical examinations and several aspects of daily life, e. g., employment, days of absence from work and other economic aspects.

Results: In contrast to KU 1, in KU 2 there is a highly significant improvement (p<0.0001) in all studied clinical symptoms and aspects of managing daily life. A significant increase of the SF-12® health survey score could also be identified. Mental score showed a higher increase than physical score. Included patients were less absent from work before KU 2, (absent 4.5%, median 4 days in euthyroid state [range 2–5 d]), vs. before KU 1 (absent 47.8%, median 10 days in hypothyroid state [range 1–30 d]). After KU 2 7.7% of the euthyroid patients was absent from work (median 5 days) while 37.5% was after KU 1 (median 6 days).

Conclusion: Included patients benefited subjectively and objectively from the use of rhTSH for diagnostic procedures in the treatment of DTC. A clear preference (127 of 128) of analyzed patients could be identified for exogenous stimulation with rhTSH.

References

  • 1 Billewicz WZ, Chapman RS, Crooks J. et al . Statistical methods applied to the diagnosis of hypothyroidism.  Q J Med. 1969;  38 ((150)) 255-266
  • 2 Borget I, Corone C, Nocaudie M. et al . Sick leave for follow-up control in thyroid cancer patients: comparison between stimulation with thyrogen and thyroid hormone withdrawal.  Eur J Endocrin. 2007;  156 ((5)) 531-538
  • 3 Borget I, Remy H, Chevalier J. et al . Length and cost of hospital stay of radioiodine ablation in thyroid cancer patients: comparison between preparation with thyroid hormone withdrawal and thyrogen.  Eur J Nucl Med Mol Imaging. 2008;  35 ((8)) 1457-1463
  • 4 Botella-Carretero JI, Gomez-Bueno M, Barrios V. et al . Chronic thyrotropin-suppressive therapy with levothyroxine and short-term overt hypothyroidism after thyroxine withdrawal are associated with undesirable cardiovascular effects in patients with differentiated thyroid carcinoma.  Endocrine-Related Cancer. 2004;  11 ((2)) 345-356
  • 5 Cohen O, Dabhi S, Karasik A. et al . Compliance with follow-up and the informative value of diagnostic whole-body scan in patients with differentiated thyroid carcinoma given recombinant human TSH.  Eur J Endocrin. 2004;  150 ((3)) 285-290
  • 6 Constant EL, de Volder AG, Ivanoiu A. et al . Cerebral blood flow and glucose metabolism in hypothyroidism: a positron emission tomography study.  J Clin Endocrinol Metabol. 2001;  86 ((8)) 3864-3870
  • 7 Dietlein M, Dressler J, Eschner W. et al . Procedure guideline for I-131 whole-body scintigraphy for differentiated thyroid cancer (version 2).  Nuklearmedizin. 2003;  42 ((3)) 123-125
  • 8 Dietlein M, Dressler J, Eschner W. et al . Procedure guideline for iodine-131 whole-body scintigraphy for differentiated thyroid cancer (version 3).  Nuklearmedizin. 2007;  46 ((5)) 206-212
  • 9 Dietlein M, Dressler J, Escher W. et al . Procedure guidelines for radioiodine therapy of differentiated thyroid cancer (version 3).  [German]. Nuklearmedizin. 2007;  46 ((5)) 213-219
  • 10 Dow KH, Ferrell BR, Anello C. Quality-of-life changes in patients with thyroid cancer after withdrawal of thyroid hormone therapy.  Thyroid. 1997;  7 ((4)) 613-619
  • 11 Duntas LH, Biondi B. Short-term hypothyroidism after levothyroxine-withdrawal in patients with differentiated thyroid cancer: clinical and quality of life consequences.  Eur J Endocrinol. 2007;  156 ((1)) 13-19
  • 12 Franchini M. Hemostatic changes in thyroid diseases.  Hematology. 2006;  11 ((3)) 203-208
  • 13 Gandek B, Sinclair SJ, Kosinski M. et al . Psychometric evaluation of the SF-36 health survey in Medicare managed care.  Health Care Financ Rev. 1998;  25 ((4)) 5-25
  • 14 Goldberg P. Life-threatening hypothyroidism during thyroid hormone withdrawal for routine thyroid cancer surveillance.  Endocrinologist. 2007;  17 ((2)) 116-118
  • 15 Haugen BR, Cooper DS, Emerson CH. et al . Expanding indications for recombinant human TSH in thyroid cancer.  Thyroid. 2008;  18 ((7)) 687-694
  • 16 den Hollander JG, Wulkan RW, Mantel MJ. et al . Correlation between severity of thyroid dysfunction and renal function.  Clin Endocrinol. 2005;  62 ((4)) 423-427
  • 17 Leboeuf R, Perron P, Carpentier AC. et al . L-T3 preparation for whole-body scintigraphy: a randomized-controlled trial.  Clin Endocrinol (Oxf). 2007;  67 ((6)) 839-844
  • 18 Lien EA, Nedrebo BG, Varhaug JE. et al . Plasma total homocysteine levels during short-term iatrogenic hypothyroidism.  J Clin Endocrinol Metabol. 2000;  85 ((3)) 1049-1053
  • 19 Luster M. Present status of the use of recombinant human TSH in thyroid cancer management.  Acta Oncol. 2006;  45 ((8)) 1018-1030
  • 20 Luster M, Felbinger R, Dietlein M. et al . Thyroid hormone withdrawal in patients with differentiated thyroid carcinoma: a one hundred thirty-patient pilot survey on consequences of hypothyroidism and a pharmacoeconomic comparison to recombinant thyrotropin administration.  Thyroid. 2005;  15 ((10)) 1147-1155
  • 21 Mernagh P, Campbell S, Dietlein M. et al . Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective.  Eur J Endocrinol. 2006;  155 ((3)) 405-414
  • 22 Münte TF, Lill C, Otting G. et al . Cognitive changes in short-term hypothyroidism assessed with event-related brain potentials.  Psychoneuroendocrinology. 2004;  29 ((9)) 1109-1118
  • 23 Nagamachi S, Jinnouchi S, Nishii R. et al . Cerebral blood flow abnormalities induced by transient hypothyroidism after thyroidectomy – Analysis by Tc-99 m-HMPAO and SPM96.  Ann Nucl Med. 2004;  18 ((6)) 469-477
  • 24 Nijhuis TF, van Weperen W, de Klerk JMH. Costs associated with the withdrawal of thyroid hormone suppression therapy during the follow-up treatment of well-differentiated thyroid cancer.  Tijdschr Nucl Geneeskd. 1999;  21 98-100
  • 25 Reiners C, Dietlein M, Luster M. Radio-iodine therapy in differentiated thyroid cancer: indications and procedure.  Best Pract Res Clin Endocrinol Metab.. 2008;  22 ((6)) 989-1007 . Review 
  • 26 Rosenthal MS. The impaired hypothyroid patient: ethical considerations and obligations.  Thyroid. 2007;  17 ((12)) 1261-1267
  • 27 Schroeder PR, Haugen BR, Pacini F. et al . A comparison of short-term changes in health-related quality of life in thyroid carcinoma patients undergoing diagnostic evaluation with recombinant human thyrotropin compared with thyroid hormone withdrawal.  J Clin Endocrinol Metab. 2006;  91 ((3)) 878-884
  • 28 Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.  Med Care. 1996;  34 ((3)) 220-233
  • 29 Woolam GL. Cancer statistics, 2000: a benchmark for the new century.  CA Cancer J Clin. 2000;  50 ((1)) 6

Correspondence

Dr. C. Dueren

Department of Nuclear Medicine

University of Wuerzburg

Josef-Schneider-Straße 2

97080 Wuerzburg

Germany

Telefon: +49/9312/013 58 68

Fax: +49/9312/013 59 70

eMail: dueren_c@klinik.uni-wuerzburg.de