Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer.
Schlumberger, Martin M.D.; Catargi, Bogdan M.D., Ph.D.; Borget, Isabelle Pharm.D., Ph.D.; Deandreis, Desiree M.D.; Zerdoud, Slimane M.D.; Bridji, Boumediene M.D., Ph.D.; Bardet, Stephane M.D.; Leenhardt, Laurence M.D., Ph.D.; Bastie, Delphine M.D.; Schvartz, Claire M.D.; Vera, Pierre M.D., Ph.D.; Morel, Olivier M.D.; Benisvy, Danielle M.D.; Bournaud, Claire M.D.; Bonichon, Francoise M.D.; Dejax, Catherine M.D.; Toubert, Marie-Elisabeth M.D.; Leboulleux, Sophie M.D.; Ricard, Marcel Ph.D.; Benhamou, Ellen M.D.; for the Tumeurs de la Thyroide Refractaires Network for the Essai Stimulation Ablation Equivalence Trial *
[Article]
New England Journal of Medicine.
366(18):1663-1673, May 3, 2012.
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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 (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.
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 131I 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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