Summary: In a phase 3 non-inferiority trial in intermediate-risk differentiated thyroid cancer, recombinant human TSH (SNA001) plus radioactive iodine was non-inferior to thyroid hormone withdrawal for ablation success and caused roughly half as many adverse events.
PICO Summary
| Element | Detail |
|---|---|
| Population | 307 patients with predominantly intermediate-risk differentiated thyroid cancer after total/near-total thyroidectomy, 19 sites in China. |
| Intervention | Recombinant human TSH (SNA001) 0.9 mg IM daily for 2 days, then 3.7 GBq radioactive iodine (n=154). |
| Comparison | Thyroid hormone withdrawal for 3–6 weeks plus 3.7 GBq radioactive iodine (n=153). |
| Outcome | Ablation success 43.8% (rhTSH) vs 47.1% (THW), risk difference -3.3 (95% CI -14.8 to 8.3) — non-inferiority met. Adverse events 29.9% vs 58.8% (p<0.001); no rhTSH discontinuations. |
rhTSH vs Withdrawal for RAI Ablation
Non-inferiority RCT · intermediate-risk thyroid cancer · phase 3
rhTSH was non-inferior to thyroid hormone withdrawal for radioiodine ablation success and roughly halved adverse events, supporting it as the default preparation in intermediate-risk thyroid cancer.
Expert Commentary
Thyroid hormone withdrawal works but is genuinely miserable, weeks of iatrogenic hypothyroidism with fatigue, low mood, and cognitive fog, so a euthyroid alternative that matches it on efficacy is exactly the kind of evidence that improves patient experience. This trial earns a positive verdict for extending recombinant TSH from low-risk into intermediate-risk disease, where data were thinner, and the halving of adverse events is a real, patient-meaningful gain. Two honest caveats keep me measured. First, non-inferiority shows not-worse, not better, and the design’s margin matters. Second, and worth saying plainly, the absolute ablation success was modest and similar in both arms, in the mid-forties percent, which says more about ablation criteria and dosing in intermediate-risk disease than about the stimulation method, and longer-term recurrence outcomes were not the endpoint. Can I use this with my patients? Yes, comfortably. For most patients receiving radioactive iodine, including intermediate-risk, this supports recombinant TSH as the default preparation, sparing weeks of hypothyroidism, reserving withdrawal for where rhTSH is unavailable. I would still want recurrence follow-up to confirm equivalence holds beyond the ablation endpoint.
References
Tan H, Gu Y, Xiu Y, et al. Recombinant human thyrotropin plus radioactive iodine among patients with thyroid cancer: a noninferiority randomized clinical trial. JAMA Netw Open. 2024;7(11):e2443407. doi:10.1001/jamanetworkopen.2024.43407