To give or not to give? A critical appraisal of a clinical trial on radioiodine treatment
Tuncel, Murat; Vrachimis, Alexis; Campenni, Alfredo; de Keizer, Bart; Verburg, Frederik A.; Kreissl, Michael C.; Ovcaricek, Petra Petranovic; Geliashvili, Tamara; Giovanella, Luca
(2022) European Journal of Nuclear Medicine and Molecular Imaging, volume 49, issue 10, pp. 3316 - 3319
(Editorial)
Abstract
Recently , Leboulleux et al. published the results of the ESTIMABL 2 trial [1]. It is an open-label, randomised, phase III trial using a noninferiority comparison design. In this study, included patients were at the lowest-risk end of the low-risk spectrum of differentiated thyroid cancer (DTC) treated with total thyroidectomy
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with or without lymph node dissection. Patients were randomised to receive low-dose postoperative radioiodine therapy (RAI) with 1.1 GBq in one group and follow-up without RAI in the second group. We congratulate the authors for this work, representing one of the few randomised trials available in the field. However, we would point out some potential limitations that need to be considered before translating these results to generalised clinical recommendations.
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Keywords: Clinical Trial Protocols as Topic, Humans, Iodine Radioisotopes/therapeutic use, Thyroid Neoplasms/drug therapy, Radiology Nuclear Medicine and imaging, Editorial
ISSN: 1619-7070
Publisher: Springer-Verlag
Note: Funding Information: Michael C. Kreissl has served on advisory boards for Bayer HealthCare, Eisai, Exelixis, and Ipsen and has received event sponsorship from Bayer HealthCare, Eisai, Ipsen, GE Healthcare, Siemens, and Curium; speaker honoraria from Eisai, Exelixis, GE Healthcare, Takeda, Sanofi, Genzyme, and Ipsen; research funding from GE Healthcare and Sanofi Genzyme; and travel funding from Ipsen and Sanofi Genzyme. Frederik A. Verburg has received speaker honoraria from Sanofi and AstraZeneca, and research funding from EISAI. All other authors declare no competing interests.
(Peer reviewed)