TY - JOUR
T1 - To give or not to give? A critical appraisal of a clinical trial on radioiodine treatment
AU - Tuncel, Murat
AU - Vrachimis, Alexis
AU - Campenni, Alfredo
AU - de Keizer, Bart
AU - Verburg, Frederik A.
AU - Kreissl, Michael C.
AU - Ovcaricek, Petra Petranovic
AU - Geliashvili, Tamara
AU - Giovanella, Luca
N1 - 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.
PY - 2022/8
Y1 - 2022/8
N2 - 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 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.
AB - 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 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.
KW - Clinical Trial Protocols as Topic
KW - Humans
KW - Iodine Radioisotopes/therapeutic use
KW - Thyroid Neoplasms/drug therapy
UR - https://www.scopus.com/pages/publications/85130468975
U2 - 10.1007/s00259-022-05841-6
DO - 10.1007/s00259-022-05841-6
M3 - Editorial
C2 - 35581502
AN - SCOPUS:85130468975
SN - 1619-7070
VL - 49
SP - 3316
EP - 3319
JO - European Journal of Nuclear Medicine and Molecular Imaging
JF - European Journal of Nuclear Medicine and Molecular Imaging
IS - 10
ER -