Leboulleux Sophie, Bournaud Claire, Chougnet Cecile N, Lamartina Livia, Zerdoud Slimane, Do Cao Christine, Catargi Bogdan, Dygai Inna, Kelly Antony, Barge Marie-Luce, Vera Pierre, Rusu Daniela, Schneegans Olivier, Roux Julie, Raymond Perrine, Benisvy Danielle, Eberle Marie-Claude, Bidault Sophie, Nascimento Camila, Bastie Delphine, Giraudet Anne-Laure, Bardet Stéphane, Le Moullec Nathalie, Roudaut Nathalie, Drui Delphine, Godbert Yann, Zalzali Mohamad, Drutel Anne, Morel Olivier, Velayoudom Fritz-Line, Al Ghuzlan Abir, Schlumberger Martin, Buffet Camille, Borget Isabelle
Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Paris, France; University Paris-Saclay, Paris, France; Department of Endocrinology and Diabetology, Hôpitaux Universitaires de Genève, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Department of Nuclear Medicine, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron, France.
Lancet Diabetes Endocrinol. 2025 Jan;13(1):38-46. doi: 10.1016/S2213-8587(24)00276-6. Epub 2024 Nov 22.
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 (I) administration compared with a postoperative I administration at 3 years post-randomisation. Here, we report a pre-specified analysis after 5 years of follow-up.
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 I 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.
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).
The non-inferiority of a follow-up strategy compared with postoperative I 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.
Programme de Recherche Hospitalier Clinique.
ESTIMABL2是一项针对低风险分化型甲状腺癌患者（即pT1am或pT1b，N0[无区域淋巴结受累证据]或Nx[未行颈部清扫时无法评估的区域淋巴结受累情况]）的多中心随机3期试验，结果显示，随机分组3年后，不进行放射性碘（I）治疗的随访策略与术后进行I治疗相比，具有非劣效性。在此，我们报告5年随访后的一项预先设定的分析。
接受全甲状腺切除术（无论是否行预防性颈部淋巴结清扫）且术后颈部超声检查无可疑发现的患者，被随机分配至无放射性碘组或放射性碘组（重组人促甲状腺激素刺激后给予1.1GBq-30mCi）。随访包括左甲状腺素治疗期间每年测定甲状腺球蛋白和甲状腺球蛋白抗体，以及在奇数年份进行颈部超声检查。事件定义为治疗后全身扫描中I摄取异常灶需要后续治疗、颈部超声检查异常、甲状腺球蛋白水平升高、甲状腺球蛋白抗体滴度增加或出现（使用相同实验室检测方法），或这些定义的组合。如果一组中无事件患者的比例及其可信区间与另一组相比差异不超过-5%，则表明随机分组5年后该组与另一组相比具有非劣效性。本研究已在ClinicalTrials.gov注册（NCT01837745）且已完成。
在纳入的776例患者（n=642[82.7%]为女性，n=134[17.3%]为男性，中位年龄52.9岁[IQR 42.6-63.1]）中，698例在5年时可进行评估。无放射性碘组无事件患者的比例为93.2%，放射性碘组为94.8%，差异为-1.6%（90%CI -4.5至1.4）。事件包括结构或功能异常（n=11）和生物学异常（n=31）。
5年时证实了低风险分化型甲状腺癌随访策略与术后I治疗相比具有非劣效性。对这些患者不进行术后消融随访不会错失机会。
临床医院研究项目。
