Martin Schlumberger1, Sophie Leboulleux1, Bogdan Catargi2, Desiree Deandreis3, Slimane Zerdoud4, Stephane Bardet5, Daniela Rusu6, Yann Godbert7, Camille Buffet8, Claire Schvartz9, Pierre Vera10, Olivier Morel11, Danielle Benisvy12, Claire Bournaud13, Marie-Elisabeth Toubert14, Antony Kelly15, Ellen Benhamou16, Isabelle Borget17. 1. Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Paris, France; University Paris-Saclay, Paris, France. 2. Endocrinology, CHU Bordeaux, Bordeaux, France. 3. Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Paris, France. 4. Nuclear Medicine, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France. 5. Nuclear Medicine, Centre François Baclesse, Caen, France. 6. Nuclear Medicine, Centre René Gauducheau, Nantes, France. 7. Nuclear Medicine, Institut Bergonié, Bordeaux, France. 8. Endocrinology, Hôpital Pitié-Salpétrière, Paris, France. 9. Nuclear Medicine, Institut Jean Godinot, Reims, France. 10. Nuclear Medicine, Centre Becquerel, Rouen, France. 11. Nuclear Medicine, ICO Paul Papin, Angers, France. 12. Nuclear Medicine, Centre Lacassagne, Nice, France. 13. Nuclear Medicine, CHU Lyon, France. 14. Nuclear Medicine, Hôpital Saint-Louis, Paris, France. 15. Nuclear Medicine, Centre Jean Perrin, Clermont-Ferrand, France. 16. Biostatistics and Epidemiology, Gustave Roussy, Paris, France. 17. Biostatistics and Epidemiology, Gustave Roussy, Paris, France; University Paris-Saclay, Paris, France. Electronic address: isabelle.borget@gustaveroussy.fr.
Abstract
BACKGROUND: In ESTIMABL1, a randomised phase 3 trial of radioactive iodine (131I) administration after complete surgical resection in patients with low-risk thyroid cancer, 92% of patients had complete thyroid ablation at 6-10 months, defined as a recombinant human thyroid-stimulating hormone (rhTSH)-stimulated serum thyroglobulin concentration of 1 ng/mL or less and normal findings on neck ultrasonography. Equivalence was shown between low-activity (1·1 GBq) and high-activity (3·7 GBq) radioactive iodine and also between the use of rhTSH injections and thyroid hormone withdrawal. Here, we report outcomes after 5 years of follow-up. METHODS: This multicentre, randomised, open-label, equivalence trial was done at 24 centres in France. Between March 28, 2007, and Feb 25, 2010, we randomly assigned (1:1:1:1) adults with low-risk differentiated thyroid carcinoma who had undergone total thyroidectomy to one of four strategies, each combining one of two methods ofthyrotropin stimulation (rhTSH or thyroid hormone withdrawal) and one of two radioactive iodine activities (1·1 GBq or 3·7 GBq). Randomisation was by computer-generated sequence, with variable block size. Follow-up consisted of a yearly serum thyroglobulin measurement on levothyroxine treatment. Measurement of rhTSH-stimulated thyroglobulin and neck ultrasonography were done at the discretion of the treating physician. No evidence of disease was defined as serum thyroglobulin of 1 ng/mL or less on levothyroxine treatment and normal results on neck ultrasonography, when performed. This study was registered with ClinicalTrials.gov, number NCT00435851. FINDINGS:726 patients (97% of the 752 patients originally randomised) were followed up. At a median follow-up since randomisation of 5·4 years (range 0·5-9·2), 715 (98%) had no evidence of disease. The other 11 had either structural disease (n=4), raised serum thyroglobulin concentration (n=5), or indeterminate findings on neck ultrasonography (n=2). At ablation, six of these patients had received 1·1 GBq radioactive iodine (five after rhTSH and one after withdrawal) and five had received 3·7 GBq (two after rhTSH and three after withdrawal). TSH-stimulated (either after rhTSH injections or thyroid hormone withdrawal according to the treatment group) thyroglobulin concentration measured at the time of ablation was prognostic for structural disease status at ablation, ablation status at 6-10 months, and the final outcome. INTERPRETATION: Our findings suggest that disease recurrence was not related to the strategy used for ablation. These data validate the use of 1·1 GBq radioactive iodine after rhTSH for postoperative ablation in patients with low-risk thyroid cancer. FUNDING: French National Cancer Institute (INCa), French Ministry of Health, and Sanofi Genzyme.
RCT Entities:
BACKGROUND: In ESTIMABL1, a randomised phase 3 trial of radioactive iodine (131I) administration after complete surgical resection in patients with low-risk thyroid cancer, 92% of patients had complete thyroid ablation at 6-10 months, defined as a recombinant human thyroid-stimulating hormone (rhTSH)-stimulated serum thyroglobulin concentration of 1 ng/mL or less and normal findings on neck ultrasonography. Equivalence was shown between low-activity (1·1 GBq) and high-activity (3·7 GBq) radioactive iodine and also between the use of rhTSH injections and thyroid hormone withdrawal. Here, we report outcomes after 5 years of follow-up. METHODS: This multicentre, randomised, open-label, equivalence trial was done at 24 centres in France. Between March 28, 2007, and Feb 25, 2010, we randomly assigned (1:1:1:1) adults with low-risk differentiated thyroid carcinoma who had undergone total thyroidectomy to one of four strategies, each combining one of two methods of thyrotropin stimulation (rhTSH or thyroid hormone withdrawal) and one of two radioactive iodine activities (1·1 GBq or 3·7 GBq). Randomisation was by computer-generated sequence, with variable block size. Follow-up consisted of a yearly serum thyroglobulin measurement on levothyroxine treatment. Measurement of rhTSH-stimulated thyroglobulin and neck ultrasonography were done at the discretion of the treating physician. No evidence of disease was defined as serum thyroglobulin of 1 ng/mL or less on levothyroxine treatment and normal results on neck ultrasonography, when performed. This study was registered with ClinicalTrials.gov, number NCT00435851. FINDINGS: 726 patients (97% of the 752 patients originally randomised) were followed up. At a median follow-up since randomisation of 5·4 years (range 0·5-9·2), 715 (98%) had no evidence of disease. The other 11 had either structural disease (n=4), raised serum thyroglobulin concentration (n=5), or indeterminate findings on neck ultrasonography (n=2). At ablation, six of these patients had received 1·1 GBq radioactive iodine (five after rhTSH and one after withdrawal) and five had received 3·7 GBq (two after rhTSH and three after withdrawal). TSH-stimulated (either after rhTSH injections or thyroid hormone withdrawal according to the treatment group) thyroglobulin concentration measured at the time of ablation was prognostic for structural disease status at ablation, ablation status at 6-10 months, and the final outcome. INTERPRETATION: Our findings suggest that disease recurrence was not related to the strategy used for ablation. These data validate the use of 1·1 GBq radioactive iodine after rhTSH for postoperative ablation in patients with low-risk thyroid cancer. FUNDING: French National Cancer Institute (INCa), French Ministry of Health, and Sanofi Genzyme.
Authors: Luca Giovanella; Anca M Avram; Jerome Clerc; Elif Hindié; David Taïeb; Frederik A Verburg Journal: Eur J Nucl Med Mol Imaging Date: 2018-07-30 Impact factor: 9.236
Authors: Malik E Juweid; Nidal J Rabadi; Mark Tulchinsky; Mohammed Aloqaily; Ahmad Al-Momani; Majd Arabiat; Gassem Abu Ain; Hussam Al Hawari; Munther Al-Momani; Ayman Mismar; Amr Abulaban; Ibrahim Taha; Abdullah Alhouri; Ayman Zayed; Nader Albsoul; Mousa A Al-Abbadi Journal: Endocrine Date: 2021-03-27 Impact factor: 3.633
Authors: Ayanthi Wijewardene; Matti Gild; Carolina Nylén; Geoffrey Schembri; Paul Roach; Jeremy Hoang; Ahmad Aniss; Anthony Glover; Mark Sywak; Stan Sidhu; Diana Learoyd; Bruce Robinson; Lyndal Tacon; Roderick Clifton-Bligh Journal: Eur Thyroid J Date: 2021-05-25
Authors: Seong Young Kwon; Sang-Woo Lee; Eun Jung Kong; Keunyoung Kim; Byung Il Kim; Jahae Kim; Heeyoung Kim; Seol Hoon Park; Jisun Park; Hye Lim Park; So Won Oh; Kyoung Sook Won; Young Hoon Ryu; Joon-Kee Yoon; Soo Jin Lee; Jong Jin Lee; Ari Chong; Young Jin Jeong; Ju Hye Jeong; Young Seok Cho; Arthur Cho; Gi Jeong Cheon; Eun Kyoung Choi; Jae Pil Hwang; Sang Kyun Bae Journal: Eur J Nucl Med Mol Imaging Date: 2019-12-10 Impact factor: 9.236