N. Engl. J. Med. 2012-05-03
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.).
Related Questions
How you do approach adjuvant radiation recommendations (RAI and EBRT) for papillary thyroid carcinoma, tall cell variant status-post total thyroidectomy?
TCV remains the most common high risk pathological variant of well differentiated papillary thyroid cancer and often is associated with a BRAF mutation, which makes it more likely a target for systemic therapy if and when it recurs.From a postop RT perspective, it is more likely to recur both at the...
Do you prefer rhTSH for TSH stimulation instead of thyroid hormone withdrawal when treating patients with radioactive iodine for papillary thyroid carcinoma?
There are no long-term level 1 evidences to guide the decision between rhTSH stimulation and TSH withdrawal in preparation of radio-iodine ablation. Two largest randomized studies (Strategies of radioiodine ablation in patients with low-risk thyroid cancer.N Engl J Med. 2012 May; 366(18):1663-73. Ab...