TY - JOUR
T1 - Thyroidectomy without Radioiodine in Patients with Low-risk Thyroid Cancer
AU - Leboulleux, Sophie
AU - Bournaud, Claire
AU - Chougnet, Cecile N.
AU - Zerdoud, Slimane
AU - Al Ghuzlan, Abir
AU - Catargi, Bogdan
AU - Do Cao, Christine
AU - Kelly, Antony
AU - Barge, Marie Luce
AU - Lacroix, Ludovic
AU - Dygai, Inna
AU - Vera, Pierre
AU - Rusu, Daniela
AU - Schneegans, Olivier
AU - Benisvy, Danielle
AU - Klein, Marc
AU - Roux, Julie
AU - Eberle, Marie Claude
AU - Bastie, Delphine
AU - Nascimento, Camila
AU - Giraudet, Anne Laure
AU - Le Moullec, Nathalie
AU - Bardet, Stéphane
AU - Drui, Delphine
AU - Roudaut, Nathalie
AU - Godbert, Yann
AU - Morel, Olivier
AU - Drutel, Anne
AU - Lamartina, Livia
AU - Schvartz, Claire
AU - Velayoudom, Fritz Line
AU - Schlumberger, Martin Jean
AU - Leenhardt, Laurence
AU - Borget, Isabelle
N1 - Publisher Copyright:
Copyright © 2022 Massachusetts Medical Society.
PY - 2022/3/10
Y1 - 2022/3/10
N2 - BACKGROUND In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits. METHODS In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization. RESULTS Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of −0.3 percentage points (two-sided 90% CI, −2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported. CONCLUSIONS In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years.
AB - BACKGROUND In patients with low-risk differentiated thyroid cancer undergoing thyroidectomy, the postoperative administration of radioiodine (iodine-131) is controversial in the absence of demonstrated benefits. METHODS In this prospective, randomized, phase 3 trial, we assigned patients with low-risk differentiated thyroid cancer who were undergoing thyroidectomy to receive ablation with postoperative administration of radioiodine (1.1 GBq) after injections of recombinant human thyrotropin (radioiodine group) or to receive no postoperative radioiodine (no-radioiodine group). The primary objective was to assess whether no radioiodine therapy was noninferior to radioiodine therapy with respect to the absence of a composite end point that included functional, structural, and biologic abnormalities at 3 years. Noninferiority was defined as a between-group difference of less than 5 percentage points in the percentage of patients who did not have events that included the presence of abnormal foci of radioiodine uptake on whole-body scanning that required subsequent treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or elevated levels of thyroglobulin or thyroglobulin antibodies. Secondary end points included prognostic factors for events and molecular characterization. RESULTS Among 730 patients who could be evaluated 3 years after randomization, the percentage of patients without an event was 95.6% (95% confidence interval [CI], 93.0 to 97.5) in the no-radioiodine group and 95.9% (95% CI, 93.3 to 97.7) in the radioiodine group, a difference of −0.3 percentage points (two-sided 90% CI, −2.7 to 2.2), a result that met the noninferiority criteria. Events consisted of structural or functional abnormalities in 8 patients and biologic abnormalities in 23 patients with 25 events. Events were more frequent in patients with a postoperative serum thyroglobulin level of more than 1 ng per milliliter during thyroid hormone treatment. Molecular alterations were similar in patients with or without an event. No treatment-related adverse events were reported. CONCLUSIONS In patients with low-risk thyroid cancer undergoing thyroidectomy, a follow-up strategy that did not involve the use of radioiodine was noninferior to an ablation strategy with radioiodine regarding the occurrence of functional, structural, and biologic events at 3 years.
UR - http://www.scopus.com/inward/record.url?scp=85126175949&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2111953
DO - 10.1056/NEJMoa2111953
M3 - Article
C2 - 35263518
AN - SCOPUS:85126175949
SN - 0028-4793
VL - 386
SP - 923
EP - 932
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 10
ER -