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Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer
Sophie Leboulleux1, Claire Bournaud1, Cecile N Chougnet1
1From the Department of Nuclear Medicine and Endocrine Oncology (S.L., L. Lamartina, M.-J.S.), the Department of Medical Biology and Pathology (A.A.G., L. Lacroix), and the Biostatistics and Epidemiology Office, Oncostat, INSERM Unité 1018 (I.B.), Gustave Roussy and Université Paris-Saclay, Villejuif, the Nuclear Medicine Department, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron (C.B.), the Endocrine Oncology Department, Assistance Publique-Hôpitaux de Paris (AP-HP) Hôpital Saint-Louis (C.N.C.), and the Thyroid and Endocrine Tumors Unit, Pitié-Salpétrière Hospital AP-HP, Institute of Cancer IUC Sorbonne University (L. Leenhardt), Paris, the Department of Medical Imaging, Nuclear Medicine, IUCT Oncopole Toulouse-Institut Claudius Regaud (S.Z.), and the Nuclear Medicine Department, CHU Rangueil (D. Bastie), Toulouse, the Department of Endocrinology-Metabolic Diseases, Hôpital Saint-André, Centre Hospitalier Universitaire (CHU) de Bordeaux (B.C.), and the Thyroid Oncology and Nuclear Medicine Department, Institut Bergonié (Y.G.), Bordeaux, the Endocrine Department, CHRU de Lille-Hôpital Claude Huriez, Lille (C.D.C.), the Nuclear Medicine Department, Centre Jean Perrin, Clermont-Ferrand (A.K.), the Nuclear Medicine Department, Centre Eugene Marquis, Rennes (M.-L.B.), the Nuclear Medicine Department, Centre Georges François Leclerc, Dijon (I.D.), the Nuclear Medicine Department, Centre Henri Becquerel and Laboratoire QUANTif, Rouen (P.V.), the Nuclear Medicine Department, Centre René Gauducheau, Saint Herblain (D.R.), the Nuclear Medicine Department, Centre Paul Strauss, Strasbourg (O.S.), the Nuclear Medicine Department, Antoine Lacassagne, Nice (D. Benisvy), the Endocrine Department, Centre Hospitalier Régional Universitaire (CHRU) de Nancy, Hôpitaux de Brabois, Vandoeuvre Les Nancy (M.K.), the Nuclear Medicine Department, CHU Grenoble-Alpes, Grenoble (J.R.), the Nuclear Medicine Department, Institut du Cancer de Montpellier, Institut Régional du Cancer Val d'Aurelle, Montpellier (M.-C.E.), the Nuclear Medicine Department, Institut Curie Site Saint-Cloud, Saint-Cloud (C.N.), the Nuclear Medicine Department, Centre Léon Bérard, Lyon (A.-L.G.), the Endocrine Department, CHU Saint Pierre, Saint Pierre (N.L.M.), the Nuclear Medicine Department and Thyroid Unit, Centre François Baclesse, Caen (S.B.), the Endocrine Department, Institut du Thorax, CHU de Nantes-Hopital Laennec Saint-Herblain, Nantes (D.D.), the Endocrine Department, CHU La Cavale Blanche, Brest (N.R.), the Nuclear Medicine Department, Institut de Cancérologie de l'Ouest, Angers (O.M.), the Endocrine Department, CHU Dupuytren, Limoges (A.D.), the Thyroid Unit, Institut Jean Godinot, Reims (C.S.), and the Endocrine Department, CHU de Guadeloupe, Hôpital Ricou, Les Abymes (F.-L.V.) - all in France.
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. (Funded by the French National Cancer Institute; ESTIMABL2 ClinicalTrials.gov number, NCT01837745.).
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