Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer: A Noninferiority Randomized Clinical Trial
Primary result · Success rate of RAI therapyResult — go to the resultRisk difference −3.3 percentage points 95% CI −14.8 to 8.3Authors' conclusion
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.
Study context
- Population
- Patients aged 18 to 70 years with intermediate-risk differentiated thyroid cancer (DTC) after total or near-total thyroidectomy, without distant metastasis; 19 sites in Chinarandomized 1:1
- Participants
- 307 patients
- Comparison
- SNA001 vs thyroid hormone withdrawal, plus 3.7 GBq RAI
- SNA001n = 154
- Thyroid hormone withdrawal (THW)n = 153reference
- Primary endpoint
- Success rate of RAI therapy: negative diagnostic whole-body scan and stimulated thyroglobulin <1.0 ng/mL
- Follow-up
- 6 to 8 months after RAI therapy
Methodological detailsnoninferiority, open-label, phase 3, multicentre (19 sites in China), Conducted April 16, 2020, to September 9, 2021; follow-up 8 months
- Noninferiority
- Open-label
- Phase 3
- Multicentre (19 sites in China)
- Conducted April 16, 2020, to September 9, 2021; follow-up 8 months
Primary result
Success rate of RAI therapy · 6 to 8 months
Risk difference
−3.3 percentage points
95% CI −14.8 to 8.3
By group
SNA001vs THW
risk difference −3.3 percentage points (95% CI −14.8 to 8.3)
As reported in the abstract
Safety
Adverse events during RAI therapy
P < 0.001
- Adverse events during RAI therapy — Treatment-related AEs leading to discontinuation and drug modification in SNA001
- 0
Original publication
Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer: A Noninferiority Randomized Clinical Trial. JAMA Netw Open. Published 4 November 2024. doi:10.
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