Strategies of radioiodine ablation in patients with low-risk thyroid cancer Full Text
New England Journal of Medicine, 05/04/2012
Clinical Article
Schlumberger M et al. – The use of recombinant human thyrotropin and low-dose (1.1 GBq) postoperative radioiodine ablation may be sufficient for the management of low-risk thyroid cancer.
Methods- In our randomized, phase 3 trial, we compared two thyrotropin-stimulation methods (thyroid hormone withdrawal and use of recombinant human thyrotropin) and two radioiodine (131I) doses (i.e., administered activities) (1.1 GBq and 3.7 GBq) in a 2-by-2 design.
- Inclusion criteria were an age of 18 years or older; total thyroidectomy for differentiated thyroid carcinoma; tumor–node–metastasis (TNM) stage, ascertained on pathological examination (p) of a surgical specimen, of pT1 (with tumor diameter ?1 cm) and N1 or Nx, pT1 (with tumor diameter >1 to 2 cm) and any N stage, or pT2N0; absence of distant metastasis; and no iodine contamination.
- Thyroid ablation was assessed 8 months after radioiodine administration by neck ultrasonography and measurement of recombinant human thyrotropin–stimulated thyroglobulin.
- Comparisons were based on an equivalence framework.
- There were 752 patients enrolled between 2007 and 2010; 92% had papillary cancer.
- There were no unexpected serious adverse events. In the 684 patients with data that could be evaluated, ultrasonography of the neck was normal in 652 (95%), and the stimulated thyroglobulin level was 1.0 ng per milliliter or less in 621 of the 652 patients (95%) without detectable thyroglobulin antibodies.
- Thyroid ablation was complete in 631 of the 684 patients (92%).
- The ablation rate was equivalent between the 131I doses and between the thyrotropin-stimulation methods.
