The use of thyrogen in the treatment of differentiated thyroid carcinoma: an intraindividual comparison of clinical effects and implications of daily life.
OBJECTIVE
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).


CONCLUSIONS
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.
Dueren
C
C
Department of Nuclear Medicine, University of Wuerzburg, Wuerzburg, Germany. dueren_c@klinik.uni-wuerzburg.de
Dietlein
M
M
Luster
M
M
Plenzig
F
F
Steinke
R
R
Grimm
J
J
Groth
P
P
Eichhorn
W
W
Reiners
C
C
D018263:Adenocarcinoma, Follicular / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D002291:Carcinoma, Papillary / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011788:Quality of Life; D013954:Thyroglobulin / Q000097:blood; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000473:pathology; D057073:Thyrotropin Alfa / Q000627:therapeutic use*; D016896:Treatment Outcome
D057073:Thyrotropin Alfa; D013954:Thyroglobulin