Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer.

Abstract

BACKGROUND:

It is not known whether low-dose radioiodine (1.1 GBq [30 mCi]) is as effective as high-dose radioiodine (3.7 GBq [100 mCi]) for treating patients with differentiated thyroid cancer or whether the effects of radioiodine (especially at a low dose) are influenced by using either recombinant human thyrotropin (thyrotropin alfa) or thyroid hormone withdrawal.

METHODS:

At 29 centers in the United Kingdom, we conducted a randomized noninferiority trial comparing low-dose and high-dose radioiodine, each in combination with either thyrotropin alfa or thyroid hormone withdrawal before ablation. Patients (age range, 16 to 80 years) had tumor stage T1 to T3, with possible spread to nearby lymph nodes but without metastasis. End points were the rate of success of ablation at 6 to 9 months, adverse events, quality of life, and length of hospital stay.

RESULTS:

A total of 438 patients underwent randomization; data could be analyzed for 421. Ablation success rates were 85.0% in the group receiving low-dose radioiodine versus 88.9% in the group receiving the high dose and 87.1% in the thyrotropin alfa group versus 86.7% in the group undergoing thyroid hormone withdrawal. All 95% confidence intervals for the differences were within ±10 percentage points, indicating noninferiority. Similar results were found for low-dose radioiodine plus thyrotropin alfa (84.3%) versus high-dose radioiodine plus thyroid hormone withdrawal (87.6%) or high-dose radioiodine plus thyrotropin alfa (90.2%). More patients in the high-dose group than in the low-dose group were hospitalized for at least 3 days (36.3% vs. 13.0%, P<0.001). The proportions of patients with adverse events were 21% in the low-dose group versus 33% in the high-dose group (P=0.007) and 23% in the thyrotropin alfa group versus 30% in the group undergoing thyroid hormone withdrawal (P=0.11).

CONCLUSIONS:

Low-dose radioiodine plus thyrotropin alfa was as effective as high-dose radioiodine, with a lower rate of adverse events. (Funded by Cancer Research UK; ClinicalTrials.gov number, NCT00415233.).

• Authors: Ujjal Mallick, Clive Harmer, Beng Yap, Jonathan Wadsley, Susan Clarke, Laura Moss, Alice Nicol, Penelope M Clark, Kate Farnell, Ralph McCready, James Smellie, Jayne A Franklyn, Rhys John, Christopher M Nutting, Kate Newbold, Catherine Lemon, Georgina Gerrard, Abdel Abdel-Hamid, John Hardman, Elena Macias, Tom Roques, Stephen Whitaker, Rengarajan Vijayan, Pablo Alvarez, Sandy Beare, Sharon Forsyth, Latha Kadalayil, Allan Hackshaw
• Journal: The New England journal of medicine (N Engl J Med) Vol. 366 Issue 18 Pg. 1674-85 (May 03 2012) ISSN: 1533-4406 [Electronic] United States
• PMID: 22551128 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Iodine Radioisotopes
• Thyroid Hormones
• Thyrotropin Alfa

Topics

• Ablation Techniques (adverse effects, psychology)
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Combined Modality Therapy
• Female
• Follow-Up Studies
• Humans
• Hypothyroidism (etiology)
• Iodine Radioisotopes (administration & dosage, adverse effects)
• Length of Stay
• Male
• Middle Aged
• Quality of Life
• Radiotherapy Dosage
• Thyroid Hormones (blood, therapeutic use)
• Thyroid Neoplasms (drug therapy, radiotherapy, surgery)
• Thyroidectomy
• Thyrotropin Alfa (adverse effects, therapeutic use)
• Treatment Outcome
• Young Adult