Recombinant thyrotropin use in children and adolescents with differentiated thyroid cancer: a multicenter retrospective study.
BACKGROUND
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.


METHODS
We conducted a retrospective study involving 23 tertiary referral centers in 12 European, Asian, and Oceanian countries.


METHODS
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.


METHODS
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").


METHODS
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.
Luster
Markus
M
Department of Nuclear Medicine, University of Würzburg, 97080 Würzburg, Germany. Markus.Luster@uniklinik-ulm.de
Handkiewicz-Junak
Daria
D
Grossi
Armando
A
Zacharin
Margaret
M
Taïeb
David
D
Cruz
Ofelia
O
Hitzel
Anne
A
Casas
Juan Antonio Vallejo
JA
Mäder
Uwe
U
Dottorini
Massimo E
ME
D000284:Administration, Oral; D000293:Adolescent; D000704:Analysis of Variance; D001208:Asia; D002277:Carcinoma / Q000097:blood / Q000601:surgery; D002648:Child; D002675:Child, Preschool; D005060:Europe; D005260:Female; D006801:Humans; D007037:Hypothyroidism / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D044349:Oceania; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design; D012189:Retrospective Studies; D013964:Thyroid Neoplasms / Q000097:blood / Q000532:radiotherapy / Q000601:surgery; D013965:Thyroidectomy / Q000009:adverse effects; D013972:Thyrotropin / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use*
D011994:Recombinant Proteins; D013972:Thyrotropin