To give or not to give? A critical appraisal of a clinical trial on radioiodine treatment

Tuncel, Murat; Vrachimis, Alexis; Campennì, Alfredo; Keizer, Bart de; Verburg, Frederik A.; Kreißl, Michael C.; Ovčariček, Petra Petranović; Гелиашвили, Т. М.; Giovanella, Luca

doi:10.1007/s00259-022-05841-6

Cited by 7 publications

(3 citation statements)

References 19 publications

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“…In a current analysis of the ESTIMABL2-trial patients with low-risk thyroid cancer after thyroidectomy, a follow-up strategy that did not involve the use of radioiodine (1.1 GBq) was non-inferior to an ablation strategy with radioiodine, regarding the occurrence of functional, structural, and biologic events at 3 years’ follow-up [ 21 ]. The main criticisms of this study, as stated by specialists such as those from the group of Tuncel et al, are the low activity of 1.1 GBq (which induces remnant ablation, no adjuvant therapy [ 16 ]), the study population (pT1a/b, N0/x) covering only a part of the low-risk group, and the short follow-up period, which, according to the work of Sawka et al, should be at least 10 years [ 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

Application of the American Thyroid Association Risk Assessment in Patients with Differentiated Thyroid Carcinoma in a German Population

et al. 2023

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Background: The American Thyroid Association (ATA) uses criteria to assess the risk for persistent disease in differentiated thyroid carcinoma (DTC) after radioiodine therapy (RAI). There are no data available showing that this classification can be adopted unadjusted by Germany. Aim: The aim of our study is to investigate whether the ATA classification can be applied to a German population for short-term prognosis. Furthermore, we investigated the influence of an age cutoff value. Methods: We retrospectively analyzed 121 patients who were referred to our tertiary referral center. Patients were classified into risk categories, and the therapy response was determined according to ATA. Results: A total of 73/83 (88%) ATA low-risk patients and 12/19 (63%) intermediate-risk patients showed an excellent response; 2/19 (11%) high-risk patients had a biochemical, and 6 (31%) had a structural incomplete response. Of all 39 patients ≥55 years, 84% had an excellent response. Using a cut off of 50 years, 50/62 (81%) of the older patients showed an excellent response. Conclusion: The ATA risk classification is able to estimate the response to RAI therapy in a German population. A shift from 55 to 50 years as an age cutoff value does not result in any relevant change in the treatment response.

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Section: Discussionmentioning

confidence: 99%

Application of the American Thyroid Association Risk Assessment in Patients with Differentiated Thyroid Carcinoma in a German Population

et al. 2023

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“…A similar study, IoN, is currently investigating this question with incorporation of a higher risk group (up to T3 and N1a disease) (7). Nevertheless, further work may also be required with respect to larger patient groups and long follow-ups (8). Two randomised trials (HiLo and ESTIMABL1) reported similar post-ablation success at 6-9 months and recurrence rates in patients with well-differentiated thyroid cancer when comparing 1.1 GBq and 3.7 GBq (9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Initial results of the INSPIRE clinical trial—investigating radiation dosimetry for differentiated thyroid cancer patients

et al. 2023

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IntroductionThe optimal strategy for differentiated thyroid cancer (DTC) patients treated with radioiodine (RAI) following thyroidectomy remains controversial. Multi-centre clinical studies are essential to identify strategies to improve patient outcomes while minimising treatment-induced toxicity.MethodsThe INSPIRE clinical trial (ClinicalTrials.gov Identifier: NCT04391244) aims to investigate patient-specific dosimetry for DTC patients and to determine the range of absorbed doses delivered to target and non-target tissues and their relationship with treatment outcome and toxicity.ResultsWe report here initial results of the first 30 patients enrolled onto the INSPIRE trial. A large range of absorbed doses are observed for both thyroid remnants and salivary glands, with median values of 4.8 Gy (Range 0.2 – 242 Gy) and 0.3 Gy (Range 0.1 to 1.7 Gy), respectively.DiscussionThe preliminary study results are encouraging and could help to improve our understanding of absorbed doses to thyroid remnants and normal organs following RAI therapy. Such knowledge could potentially enable patient-specific treatment planning with improved clinical outcomes and quality-of-life of patients.

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“…An open-label, phase III, non-inferiority trial study randomized low-risk DTC patients to postoperative administration of 1.1 GBq 131 I versus no ablation [ 12 ]. The authors did not find differences in outcomes after 3 years in the different groups, but acknowledged several limitations, pointing out in particular that the 3-year period applied was too short to draw definitive conclusions [ 13 , 14 ]. Their critical analysis was correctly addressed to clinical readers via a well-recognized medical journal.…”

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confidence: 99%

To give or not to give? A critical appraisal of a clinical trial on radioiodine treatment

Cited by 7 publications

References 19 publications

Application of the American Thyroid Association Risk Assessment in Patients with Differentiated Thyroid Carcinoma in a German Population

Application of the American Thyroid Association Risk Assessment in Patients with Differentiated Thyroid Carcinoma in a German Population

Initial results of the INSPIRE clinical trial—investigating radiation dosimetry for differentiated thyroid cancer patients

Radioiodine therapy in differentiated thyroid cancer. There is (still) a great chaos under heaven: is the situation excellent?

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