Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer

作者：Hui Tan, Yushen Gu, Yan Xiu, Xingmin Han, Qiang Wen, Zhongwei Lv, Wei Fan, Sijin Li, Jian Tan, Feng Wang, Wei Fu, Yifan Zhang, Jun Xin, Wei Ouyang, Xuemei Wang, Bin Liu, Yue Chen, Xuegong Liu, Mo Yi, Quan‐Yong Luo, Jing Wang, Meng Li, Yan Di, Tao Xu, Hongcheng Shi · 发表于：JAMA Network Open · 年份：2024 · DOI：10.1001/jamanetworkopen.2024.43407 · 被引用次数：5 · 研究领域：Thyroid Cancer Diagnosis and Treatment、Thyroid and Parathyroid Surgery、Thyroid Disorders and Treatments

Importance: Radioactive iodine (131I or RAI) therapy has long been the standard of care for most patients with differentiated thyroid cancer (DTC) after primary surgery. However, no multicenter prospective studies have identified the optimal administered activity and stimulation method for RAI therapy in patients with intermediate-risk DTC. Objective: To compare the efficacy and safety of recombinant human thyrotropin (SNA001) with thyroid hormone withdrawal (THW) plus 3.7 GBq RAI in patients with intermediate-risk DTC. Design, Setting, and Participants: This noninferiority, open-label, phase 3 randomized clinical trial was conducted at 19 sites in China from April 16, 2020, to September 9, 2021, with a follow-up period of 8 months. Patients aged 18 to 70 years with DTC who had undergone a total or near-total thyroidectomy and had no distant metastasis were enrolled in the trial. Statistical analysis followed the full analysis and per-protocol analysis sets and was performed between November 18, 2021, and April 18, 2022. Intervention: Patients were randomly assigned 1:1 to receive SNA001, 0.9 mg, intramuscular injection daily for 2 days or to undergo thyroid hormone withdrawal for 3 to 6 weeks. Main Outcomes and Measures: The primary end point was the success rate after 6 to 8 months of RAI therapy. Success was defined as a negative diagnostic whole-body scan result and a stimulated thyroglobulin level less than 1.0 ng/mL. Results: A total of 307 patients (192 females [62.5%]...