Article Dans Une Revue The Lancet. Diabetes & Endocrinology Année : 2025

Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial

1 Médecine nucléaire [Gustave Roussy]
2 HCL - Hospices Civils de Lyon
3 Angiogénèse embryonnaire et pathologique
4 IGR - Institut Gustave Roussy
5 Département d'imagerie médicale [Gustave Roussy]
6 Université Paris-Saclay
7 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
8 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
9 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
10 UNICANCER/CRLCC-CGFL - Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon]
11 UNICANCER/CJP - Centre Jean Perrin [Clermont-Ferrand]
12 Département de médecine nucléaire [Rennes]
13 LITIS - QuantIF - Equipe Quantification en Imagerie Fonctionnelle
14 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
15 LPIM - Laboratoire de Photochimie et d'ingénierie macromoléculaires - LPIM - UR4567
16 ICANS - Institut de Cancérologie de Strasbourg Europe
17 CRLCC Paul Strauss - Centre Paul Strauss
18 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
19 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
20 ICM - Institut régional de Cancérologie de Montpellier
21 Oncopole Claudius Regaud
22 ICSC - Institut Curie - Saint Cloud
23 Service de Médecine Nucléaire - Pierre-Paul Riquet [CHU Toulouse]
24 Centre d'Imagerie Cardiaque
25 Centre Léon Bérard [Lyon]
26 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
27 CHU La Réunion - Centre Hospitalier Universitaire de La Réunion
28 CHU - BREST - Hopital de Bohars - CHRU Brest
29 ITX-lab - ITX-lab unité de recherche de l'institut du thorax UMR1087 UMR6291
30 Institut Bergonié [Bordeaux]
31 Institut Jean Godinot [Reims]
32 Service de Médecine interne B, Endocrinologie, Diabète, Maladies métaboliques [CHU Limoges]
33 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
34 CHU Pointe-à-Pitre / Abymes [Guadeloupe]
35 EGENODIA (GI3M) - Metabolic functional (epi)genomics and molecular mechanisms involved in type 2 diabetes and related diseases - UMR 8199 - UMR 1283
36 Département de biologie et pathologie médicales [Gustave Roussy]
37 CHU Pitié-Salpêtrière [AP-HP]
38 CESP - Centre de recherche en épidémiologie et santé des populations
39 U1018 (Équipe 2) - CESP - Oncostat
40 SBE - Service de biostatistique et d'épidémiologie
Sophie Leboulleux
  • Fonction : Auteur
  • PersonId : 1539933
Julie Roux
  • Fonction : Auteur

Résumé

Background ESTIMABL2, a multicentre randomised phase 3 trial in patients with low-risk differentiated thyroid cancer (ie, pT1am or pT1b, N0 [no evidence of regional nodal involvement] or Nx [involvement of regional lymph nodes that cannot be assessed in the absence of neck dissection]), showed the non-inferiority of a follow-up strategy without radioactive iodine (¹³¹I) administration compared with a postoperative ¹³¹I administration at 3 years post-randomisation. Here, we report a pre-specified analysis after 5 years of follow-up.

Methods Patients treated with total thyroidectomy with or without prophylactic neck lymph node dissection, without postoperative suspicious findings on neck ultrasonography, were randomly assigned to the no-radioiodine group or to the radioiodine group (1•1 GBq-30 mCi after recombinant human thyrotropin-stimulating hormone). Follow-up consisted of annual thyroglobulin and thyroglobulin antibody determinations during levothyroxine treatment and neck ultrasonography in odd-numbered years. An event was defined as abnormal foci of ¹³¹I uptake on the post-treatment whole-body-scan requiring subsequent treatment, abnormal neck ultrasonography, elevated thyroglobulin levels, increasing titres or appearance of thyroglobulin antibody (using the same laboratory assay), or a combination of these definitions. Non-inferiority of the proportion of patients without an event in one group compared with the other at 5 years after randomisation was shown if this proportion and its CI did not differ by more than -5%. This study was registered on ClinicalTrials.gov (NCT01837745) and is completed.

Findings

Of the 776 patients (n=642 [82•7%] female and n=134 [17•3%] male, median age 52•9 years [IQR 42•6-63•1]) enrolled, 698 were evaluable at 5 years. The proportions of patients without events were 93•2% in the no-radioiodine group and 94•8% in the radioiodine group, for a difference of -1•6% (90% CI -4•5 to 1•4). Events consisted of structural or functional abnormalities (n=11) and biological abnormalities (n=31).

Interpretation 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.

Funding Programme de Recherche Hospitalier Clinique.

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inserm-05062136 , version 1 (09-05-2025)

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Sophie Leboulleux, Claire Bournaud, Cecile N Chougnet, Livia Lamartina, Slimane Zerdoud, et al.. Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial. The Lancet. Diabetes & Endocrinology , 2025, 13 (1), pp.38-46. ⟨10.1016/S2213-8587(24)00276-6⟩. ⟨inserm-05062136⟩
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