TRESON-01

Trial question
Is recombinant human thyrotropin noninferior to thyroid hormone withdrawal plus radioactive iodine therapy in patients with intermediate-risk differentiated thyroid cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
63.0% female
37.0% male
N = 307
307 patients (192 female, 115 male).
Inclusion criteria: patients with intermediate-risk differentiated thyroid cancer.
Key exclusion criteria: whole-body scan conducted in the past 2 weeks; other malignant tumors; pregnancy or lactation.
Interventions
N=154 recombinant human thyrotropin SNA001 (0.9 mg injected daily for 2 days, with radioiodine 3.7 GBq ± 5% given 24 hours after the second dose).
N=153 thyroid hormone withdrawal (hormone withdrawal for 3-6 week, with radioiodine 3.7 GBq ± 5% given at thyrotropin level > 30 mIU/L).
Primary outcome
Rate of radioiodine success rate after 6-8 months of therapy
43.8%
47.1%
47.1 %
35.3 %
23.6 %
11.8 %
0.0 %
Recombinant human thyrotropin SNA001
Thyroid hormone withdrawal
Difference not exceeding non-inferiority margin ✓
Difference not exceeding non-inferiority margin in the rate of radioiodine success rate after 6-8 months of therapy (43.8% vs. 47.1%; ARD -3.3, 95% CI -14.8 to 8.3).
Secondary outcomes
No significant difference in response to therapy, excellent response (43.8% vs. 47.4%; ARD -3.6, 95% CI -14.81 to 7.61).
No significant difference in 36-Item Short-Form Health Survey total score (-1.6 points vs. 0.4 points; AD -2 points, 95% CI -12.93 to 8.93).
Significant decrease in weight gain (12.3% vs. 43%; ARD -30.7, 95% CI -40.2 to -21.3).
Safety outcomes
No significant differences in adverse events at 6 months after therapy, serious adverse events.
Significant difference in adverse events (29.9% vs. 58.8%).
Conclusion
In patients with intermediate-risk differentiated thyroid cancer, recombinant human thyrotropin SNA001 was noninferior to thyroid hormone withdrawal with respect to the rate of radioiodine success rate after 6-8 months of therapy.
Reference
Hui Tan, Yushen Gu, Yan Xiu et al. Recombinant Human Thyrotropin Plus Radioactive Iodine Among Patients With Thyroid Cancer: A Noninferiority Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443407.
Open reference URL
Create free account