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Recombinant Thyrotropin Use in Children and Adolescents with Differentiated Thyroid Cancer: A Multicenter Retrospective Study

Department of Nuclear Medicine (M.L.), Biostatistics Institute (U.M.), University of Würzburg, 97080 Würzburg, Germany; Department of Endocrine Oncology (D.H.-J.), M. Sklodowska Curie Memorial Cancer Center and Institute of Oncology, 44-100 Gliwice, Poland; Endocrine and Diabetes Unit (A.G.), Bambino Gesù Pediatric Hospital, 00165 Rome, Italy; Centre for Molecular Imaging (M.Z.), Peter MacCallum Cancer Centre and Royal Children’s Hospital (M.Z.), 3052 Melbourne, Australia; Service Central de Biophysique et de Médecine Nucléaire (D.T.), Centre Hospitalo-Universitaire de la Timone, 13385 Marseille, France; Hospital Sant Joan de Déu (O.C.), 08950 Esplugues de Llobregat, Spain; Henri Becquerel Center (A.H.), 76038 Rouen, France; Hospital Reina Sofia (J.A.V.C.), 14004 Córdoba, Spain; and Perugia Hospital (M.E.D.), 06156 Perugia, Italy

Address all correspondence and requests for reprints to: Markus Luster, M.D., Department of Nuclear Medicine, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany. E-mail: Markus.Luster{at}uniklinik-ulm.de.

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.