Document Detail


Recombinant thyrotropin use in children and adolescents with differentiated thyroid cancer: a multicenter retrospective study.
MedLine Citation:
PMID:  19773393     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: Although recombinant human TSH (rhTSH) is widely used in differentiated thyroid cancer (DTC) to aid diagnostic follow-up procedures and radioiodine thyroid remnant ablation, almost all clinical investigation was in adults. OBJECTIVE: The aim of this study was to characterize rhTSH clinical safety and peak TSH response in DTC patients 18 yr old or younger. DESIGN AND SETTING: We conducted a retrospective study involving 23 tertiary referral centers in 12 European, Asian, and Oceanian countries. PATIENTS: One hundred DTC patients (69% female, 31% male, 84% papillary, 61% N1, 18% M1) ages 4.9-18 yr at first rhTSH administration were studied. INTERVENTIONS: A total of 181 rhTSH courses were administered (range, one to eight per patient; 42% of patients received two or more courses), 92% using the approved adult regimen (one 0.9 mg im injection daily on two consecutive days), 34% including thyroid hormone withdrawal for less than 7 d ("mini-THW"). MAIN OUTCOME MEASURES: Clinical adverse event (AE) incidence, type, and severity, and peak post-rhTSH serum TSH concentrations were assessed. RESULTS: No clinical AEs occurred in 88% of rhTSH courses. Most common clinical AEs were nausea (5% of courses) and vomiting (3%). Multiple or severe AEs were rare (0.6% and 2.8% of courses, respectively); serious AEs were absent. Peak TSH concentration post-rhTSH exceeded 25 mU/liter in approximately 98% of courses. In logistic regression analyses, the rhTSH regimen, "mini-THW," peak TSH concentration, body mass index (BMI), or peak TSH concentration/unit of BMI were not associated with clinical AE occurrence. In analyses of covariance, higher BMI was associated with lower peak TSH concentrations. CONCLUSIONS: rhTSH was clinically well tolerated in pediatric DTC patients although courses preponderantly comprised the adult regimen, and repeated courses were frequent. Both the adult and reduced-dose regimens almost always sufficiently elevate TSH in children and adolescents.
Authors:
Markus Luster; Daria Handkiewicz-Junak; Armando Grossi; Margaret Zacharin; David Taïeb; Ofelia Cruz; Anne Hitzel; Juan Antonio Vallejo Casas; Uwe Mäder; Massimo E Dottorini;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2009-09-22
Journal Detail:
Title:  The Journal of clinical endocrinology and metabolism     Volume:  94     ISSN:  1945-7197     ISO Abbreviation:  J. Clin. Endocrinol. Metab.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-07     Completed Date:  2009-10-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375362     Medline TA:  J Clin Endocrinol Metab     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3948-53     Citation Subset:  AIM; IM    
Affiliation:
Department of Nuclear Medicine, University of Würzburg, 97080 Würzburg, Germany. Markus.Luster@uniklinik-ulm.de
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Analysis of Variance
Asia
Carcinoma* / blood,  surgery
Child
Child, Preschool
Europe
Female
Humans
Hypothyroidism / drug therapy,  etiology,  prevention & control
Logistic Models
Male
Multivariate Analysis
Oceania
Recombinant Proteins / therapeutic use
Research Design
Retrospective Studies
Thyroid Neoplasms* / blood,  radiotherapy,  surgery
Thyroidectomy / adverse effects
Thyrotropin / administration & dosage,  adverse effects,  blood*,  therapeutic use*
Chemical
Reg. No./Substance:
0/Recombinant Proteins; 9002-71-5/Thyrotropin
Investigator
Investigator/Affiliation:
Marcus Schneider-Ludorff / ; Frederik A Verburg / ; Christoph Reiners / ; Peter Lind / ; Isabel Igerc / ; Susanne Kohlfürst / ; Diego De Palma / ; Lutz Freudenberg / ; Andreas Bockisch / ; Giovanni Lupoli / ; Gelsy Arianna Lupoli / ; Annalisa Panico / ; Jan Tennvall / ; Claire Bournaud / ; Renzo Mazzarotto / ; Federica Vianello / ; Klaus P Kaiser / ; Luis Matos Lima / ; Thorsten Petrich / ; Lutz Bischoff / ; Wolfram Knapp / ; Sa'ad El-Deen Mahwood / ; Iman al-Shammeri / ; Amar Naoun / ; Marie-Elisabeth Toubert / ; Annick Van den Bruel / ; Barbara Jarzab / ; Kornelia Hasse-Lazar / ; Sylwia Szpak-Ulczok / ; Maria Carmen Garganese / ; Willie F E Lau / ; G Wheeler / ; V Johnston / ; R J Hicks / ; Peter MacCallum / ; K Waters / ; Olivier Mundler / ; José M Latre Romero / ; Luisa M Mena Bares / ; Robert J Marlowe /

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