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Clinical Trial
. 2012 May 3;366(18):1663-73.
doi: 10.1056/NEJMoa1108586.

Strategies of radioiodine ablation in patients with low-risk thyroid cancer

Martin Schlumberger  1 , Bogdan Catargi, Isabelle Borget, Désirée Deandreis, Slimane Zerdoud, Boumédiène Bridji, Stéphane Bardet, Laurence Leenhardt, Delphine Bastie, Claire Schvartz, Pierre Vera, Olivier Morel, Danielle Benisvy, Claire Bournaud, Françoise Bonichon, Catherine Dejax, Marie-Elisabeth Toubert, Sophie Leboulleux, Marcel Ricard, Ellen Benhamou; Tumeurs de la Thyroïde Refractaires Network for the Essai Stimulation Ablation Equivalence Trial
Collaborators, Affiliations
Free article
Clinical Trial

Strategies of radioiodine ablation in patients with low-risk thyroid cancer

Martin Schlumberger et al. N Engl J Med. .
Free article

Abstract

Background: It is not clear whether the administration of radioiodine provides any benefit to patients with low-risk thyroid cancer after a complete surgical resection. The administration of the smallest possible amount of radioiodine would improve care.

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 ((131)I) 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.

Results: 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 (131)I doses and between the thyrotropin-stimulation methods.

Conclusions: 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. (Funded by the French National Cancer Institute [INCa] and the French Ministry of Health; ClinicalTrials.gov number, NCT00435851; INCa number, RECF0447.).

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