Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial
Primary result · Patients without eventsResult — go to the resultDifference −1.6 % 90% CI −4.5 to 1.4Authors' conclusion
The non-inferiority of a follow-up strategy compared with postoperative 131I administration in low risk differentiated thyroid cancer was confirmed at 5 years. There is no loss of opportunity in following these patients without postoperative ablation.
Study context
- Population
- Patients with low-risk DTC (pT1am or pT1b, N0 or Nx) after total thyroidectomy ± prophylactic neck lymph node dissection, without postoperative suspicious findings on neck US; 82.7% female, median age 52.9 years (IQR 42.6–63.1)698 evaluable at 5 years
- Participants
- 776 patients
- Comparison
- No postoperative RAI vs postoperative RAI
- Primary endpoint
- Proportion of patients without an event (abnormal 131I uptake requiring treatment, abnormal neck US, elevated Tg, increasing or new Tg antibody, or a combination); non-inferiority if difference and its CI not beyond −5%
- Follow-up
- 5 years after randomisation
Methodological detailsmulticentre, phase 3, non-inferiority, pre-specified 5-year analysis
- Multicentre
- Phase 3
- Non-inferiority
- Pre-specified 5-year analysis
Primary result
Patients without events · 5 years
Difference
−1.6 %
90% CI −4.5 to 1.4
By group
No-radioiodinevs Radioiodine
difference −1.6 % (90% CI −4.5 to 1.4)
As reported in the abstract
Further findings
Event types
- Structural or functional abnormalities
- 11
- Biological abnormalities
- 31
Original publication
Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial. Lancet Diabetes Endocrinol. Published 22 November 2024. doi:10.
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