Estimabl2 trial: Thyroidectomy without radioiodine in patients with low-risk thyroid cancer, 5 years of follow-up - 20/09/23
, S. Leboulleux, Dr a, C. Bournaud, Dr b, C. Chougnet, Dr c, S. Zerdoud, Dr d, C. Do Cao, Dr e, B. Catargi, Dr f, I. Dygai, Dr g, A. Kelly, Dr h, M.L. Barge, Dr i, P. Vera, Dr j, D. Rusu, Dr k, O. Schneegans, Dr l, J. Roux, Dr m, M. Klein, Dr n, D. Benisvy, Dr o, M.C. Eberle, Dr p, S. Bidault, Dr a, C. Nascimento, Dr q, D. Bastie, Dr r, A.L. Giraudet, Dr s, S. Bardet, Dr t, N. Le Moullec, Dr u, N. Roudaut, Dr v, D. Drui, Dr w, Y. Godbert, Dr x, M. Zalzali, Dr y, A. Drutel, Dr z, O. Morel, Dr aa, F.L. Velayoudom, Dr ab, A. Al Ghuzlan, Dr a, M. Schlumberger, Dr a, C. Buffet, Dr ac, I. Borget, Pr adRésumé |
Background |
ESTIMABL2 is a randomized phase III trial in low-risk differentiated thyroid cancer (DTC) patients evaluating post-operative 131I administration (1.1 GBq after rhTSH) (iodine group) compared with surgery alone (no-radioiodine group). The results demonstrated the non-inferiority of the two approaches assessed 3 years after randomization. A longer follow-up was scheduled.
Methods |
The trial included patients with low-risk DTC (T1am or T1b and N0/Nx) treated with total thyroidectomy ± prophylactic neck lymph node dissection, and randomized to the no-radioiodine or to the radioiodine group.
An event was defined by abnormal foci of 131I uptake on the post-therapy whole-body-scan and/or abnormal neck-US and/or by elevated Tg levels and/or rising titres or appearance of Tg-Ab.
One aim was to assess the non-inferiority of the proportion of patients without event in the two randomization groups at 5 years after randomization. Non-inferiority was demonstrated if this proportion did not differ by more than –5%.
Results |
Among 776 low-risk DTC patients included between 2013 and 2017 in 35 French TUTHYREF network centers, 698 (83% females, mean age: 52 years) were evaluable at 5 years after randomization.
The proportion of patients without event at 5 years were 92.1% CI95%=[88.8–94.7] in the no-radioiodine group and 94.5% CI95%=[91.5; 96.6] in the radioiodine group, leading to a difference of 2.4% CI90%=[–5.5%; 0.7%], demonstrating that no radioiodine was non-inferior to radioiodine. Events consisted of structural/functional abnormalities (n=13) and biological abnormalities (n=39).
Conclusions |
This analysis confirms the non-inferiority of a follow-up strategy compared to post-operative administration of 131I in low-risk DTC patients.
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Vol 84 - N° 5
P. 557-558 - octobre 2023 Retour au numéro
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