September 25, 2009
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Combined TSH, I-131 therapy safe, effective in goiter reduction in adults

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American Thyroid Association's 80th Annual Meeting

A significant decrease in goiter was found in adults assigned to 0.03 mg intramuscular injection of modified-release recombinant human thyroid-stimulating hormone followed by I-131 therapy, according to data presented yesterday the American Thyroid Association’s 80th Annual Meeting.

“The response rate was clearly highest in the group assigned to 0.03 mg intramuscular injection of modified-release recombinant human TSH,” Laszlo Hegedüs, MD, of Odense University Hospital in Copenhagen, Denmark, said during a presentation. “We found no safety concerns and feel further study of this treatment is warranted.”

Researchers assigned 95 patients with a mean age of 57 (85% women and 83% white) to receive one of three treatments to achieve shrinkage of symptomatic benign multinodular goiters.

Patients were assigned to either a single injection of 0.01 mg modified-release recombinant human TSH (n=30), 0.03 mg modified-release recombinant human TSH — both followed 24 hours by I-131 therapy (average I-131 therapy dose: 36 mCi; n=33) — or placebo (n=32). Baseline goiter volume was 100 mL.

Researchers predefined “responders” as a patient who achieved ≥28% shrinkage of the goiter at six months. Thirty-seven percent of patients responded in the 0.01 mg dose group, 25% in the placebo group vs. 64% in the combined treatment group.

Mean goiter shrinkage at six months among patients assigned to placebo and those assigned to 0.01 mg modified-release recombinant human TSH was 23% compared with 33% of patients assigned to the combined treatment group (P<.05).

Transient hyperthyroidism occurred in 30% of patients in the combined treatment group, 27% of patients in the 0.01 mg dose group and 6% of patients in the placebo group. - by Jennifer Southall

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PERSPECTIVE

The reduction in goiter achieved in this multicenter study is similar to that described by Huysmans et al (J Clin Endocrinol Metab. 2003) who used 0.03 mg of the ordinary recombinant hTSH given 24 hr before I-131. The use of recombinant TSH increases thyroid uptake by about two-fold, thereby permitting a smaller dose of I-131 to be used. At the ATA meeting, my laboratory reported that the biologic activity of recombinant TSH is very stable, so the vial of 0.9 mg can be divided into smaller aliquots that are refrigerated and used later as the need arises for the treatment of multinodular goiter or subclinical hyperthyroidism with relatively low thyroid uptake.

– Jerome Hershman, MD

Endocrine Today Editorial Board member