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

N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.

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.).

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ablation Techniques
  • Adenocarcinoma, Follicular / drug therapy
  • Adenocarcinoma, Follicular / radiotherapy
  • Adenocarcinoma, Follicular / surgery
  • Adult
  • Carcinoma, Papillary / drug therapy
  • Carcinoma, Papillary / radiotherapy
  • Carcinoma, Papillary / surgery
  • Combined Modality Therapy
  • Female
  • Follow-Up Studies
  • Humans
  • Hypothyroidism / etiology
  • Iodine Radioisotopes / adverse effects
  • Iodine Radioisotopes / therapeutic use*
  • Male
  • Middle Aged
  • Neck / diagnostic imaging
  • Quality of Life
  • Thyroid Hormones / blood
  • Thyroid Hormones / therapeutic use
  • Thyroid Neoplasms / drug therapy
  • Thyroid Neoplasms / radiotherapy*
  • Thyroid Neoplasms / surgery
  • Thyroidectomy
  • Thyrotropin / adverse effects
  • Thyrotropin / therapeutic use*
  • Treatment Outcome
  • Ultrasonography

Substances

  • Iodine Radioisotopes
  • Thyroid Hormones
  • Thyrotropin

Associated data

  • ClinicalTrials.gov/NCT00435851