Does postoperative thyrotropin suppression therapy truly decrease recurrence in papillary thyroid carcinoma? A randomized controlled trial

J Clin Endocrinol Metab. 2010 Oct;95(10):4576-83. doi: 10.1210/jc.2010-0161. Epub 2010 Jul 21.

Abstract

Context: TSH suppression therapy has been used to decrease thyroid cancer recurrence. However, validation of effects through studies providing a high level of evidence has been lacking.

Objective: This single-center, open-label, randomized controlled trial tested the hypothesis that disease-free survival (DFS) for papillary thyroid carcinoma (PTC) in patients without TSH suppression is not inferior to that in patients with TSH suppression.

Design: Participants were randomly assigned to receive postoperative TSH suppression therapy (group A) or not (group B). Before assignment, patients were stratified into groups with low- and high-risk PTC according to the AMES (age, metastasis, extension, size) risk-group classification.

Interventions and outcome measures: For patients assigned to group A, L-T(4) was administered to keep serum TSH levels below 0.01 μU/ml. TSH levels were adjusted to within normal ranges for patients assigned to group B. Recurrence was evaluated by neck ultrasonography and chest computed tomography.

Results: Eligible participants were recruited from 1996-2005, with 218 patients assigned to group A and 215 patients to group B. Analysis was performed on an intention-to-treat basis. DFS did not differ significantly between groups. The 95% confidence interval of the hazard ratio for recurrence was 0.85-1.27 according to Cox proportional hazard modeling, within the margin of 2.12 required to declare 10% noninferiority.

Conclusions: DFS for patients without TSH suppression was not inferior by more than 10% to DFS for patients with TSH suppression. Thyroid-conserving surgery without TSH suppression should be considered for patients with low-risk PTC to avoid potential adverse effects of TSH suppression.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Carcinoma, Papillary / drug therapy*
  • Carcinoma, Papillary / surgery*
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Period
  • Recurrence
  • Thyroid Hormones / administration & dosage
  • Thyroid Hormones / therapeutic use*
  • Thyroid Neoplasms / drug therapy*
  • Thyroid Neoplasms / surgery*
  • Thyrotropin / antagonists & inhibitors*
  • Validation Studies as Topic
  • Young Adult

Substances

  • Thyroid Hormones
  • Thyrotropin