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Clinical Trial
. 2024 Nov 4;7(11):e2443407.
doi: 10.1001/jamanetworkopen.2024.43407.

Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer: A Noninferiority Randomized Clinical Trial

Hui Tan  1 , Yushen Gu  1 , Yan Xiu  1 , Xingmin Han  2 , Qiang Wen  3 , Zhongwei Lv  4 , Wei Fan  5 , Sijin Li  6 , Jian Tan  7 , Feng Wang  8 , Wei Fu  9 , Yifan Zhang  10 , Jun Xin  11 , Wei Ouyang  12 , Xuemei Wang  13 , Bin Liu  14 , Yue Chen  15 , Xuegong Liu  16 , Yi Mo  17 , Quanyong Luo  18 , Jing Wang  19 , Meng Li  20 , Yan Di  20 , Tao Xu  20 , Hongcheng Shi  1
Affiliations
Clinical Trial

Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer: A Noninferiority Randomized Clinical Trial

Hui Tan et al. JAMA Netw Open. .

Abstract

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%]; median [range] age, 40 [19-69] years) were randomized: 154 to the SNA001 group and 153 to the THW group. Baseline characteristics were evenly matched between the 2 groups. Noninferiority in the success rate of RAI therapy between groups was met, with success rates of 43.8% in the SNA001 group and 47.1% in the THW group (risk difference, -3.3; 95% CI, -14.8 to 8.3 percentage points). Forty-six patients (29.9%) in the SNA001 group reported adverse events compared with 90 (58.8%) in the THW group during RAI therapy (P < .001). No treatment-related adverse events leading to discontinuation and drug modification occurred in the SNA001 group.

Conclusions and relevance: This randomized clinical trial showed that SNA001 was noninferior to THW plus 3.7 GBq RAI in patients with predominantly intermediate-risk DTC. SNA001 also demonstrated a favorable safety profile compared with THW and had a lower incidence of adverse events.

Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100046907.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms M. Li reported being employed by Suzhou SmartNuclide Biopharma Co Ltd outside the submitted work. Mr Di reported being employed by Suzhou SmartNuclide Biopharma Co Ltd outside the submitted work. Dr Xu reported being employed by Suzhou SmartNuclide Biopharma Co Ltd outside the submitted work. Dr Shi reported receiving grants from the Innovative Medical Device Application Demonstration Program of Shanghai Municipal Commission of Economy and Informatization, the Chinese National Key Clinical Specialty Program, and the National Key Research and Development Program of China during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Trial Flow Diagram
RAI indicates radioactive iodine; SNA001, recombinant human thyrotropin; and THW, thyroid hormone withdrawal. aOne patient in the THW group was included in the per-protocol analysis set because thyrotropin levels were consistently below 30 mIU/L for over 3 weeks before RAI therapy.
See this image and copyright information in PMC

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