HiLo
Multicentre Randomised Trial of High Dose Versus Low Dose Radioiodine, With or Without Recombinant Human Thyroid Stimulating Hormone, for Remnant Ablation Following Surgery for Differentiated Thyroid Cancer [HILO]
Phase 3N = 438NCT00415233
- Population
- Patients aged 16 to 80 years with tumour stage T1 to T3, possible spread to nearby lymph nodes and no metastasis, after surgery for differentiated thyroid cancer
- Design
- Randomised non-inferiority trial at 29 UK centres, 2-by-2 factorial: low-dose (1.1 GBq) versus high-dose (3.7 GBq) radioiodine, each with thyrotropin alfa or thyroid hormone withdrawal before ablation. End points were ablation success at 6 to 9 months, adverse events, quality of life and length of hospital stay. Pooled-dose and pooled-stimulation groups are the comparisons the paper reports.
- Arms
- Low-dose radioiodine (both stimulation methods pooled) (experimental): 1.1 GBq radioiodine ablation, with thyrotropin alfa or thyroid hormone withdrawal (pooled)
- High-dose radioiodine (both stimulation methods pooled) (control): 3.7 GBq radioiodine ablation, with thyrotropin alfa or thyroid hormone withdrawal (pooled)
- Thyrotropin alfa (both doses pooled) (experimental): Thyrotropin alfa before ablation, 1.1 or 3.7 GBq (pooled)
- Thyroid hormone withdrawal (both doses pooled) (control): Thyroid hormone withdrawal before ablation, 1.1 or 3.7 GBq (pooled)
- Low dose with thyrotropin alfa (experimental): 1.1 GBq radioiodine with thyrotropin alfa
- Low dose with hormone withdrawal (experimental): 1.1 GBq radioiodine with thyroid hormone withdrawal
- High dose with thyrotropin alfa (experimental): 3.7 GBq radioiodine with thyrotropin alfa
- High dose with hormone withdrawal (control): 3.7 GBq radioiodine with thyroid hormone withdrawal
- People
- Mallick U
Δ Ablation success rate−3.9 pointsΔ Ablation success rate+0.4 pointsΔ Ablation success rate−3.3 points
Show the numbers
| Endpoint | Analysis | Low-dose radioiodine (both stimulation methods pooled) / Thyrotropin alfa (both doses pooled) / Low dose with thyrotropin alfa / Low dose with hormone withdrawal / High dose with thyrotropin alfa | High-dose radioiodine (both stimulation methods pooled) / Thyroid hormone withdrawal (both doses pooled) / High dose with hormone withdrawal | Effect |
|---|---|---|---|---|
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 85% | 88.9% | All 95% confidence intervals for the differences were within +/-10 percentage points, indicating non-inferiority (abstract). Adverse events 21% with low dose versus 33% with high dose (P=0.007); hospitalisation for at least 3 days 13.0% versus 36.3% (P<0.001). |
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 87.1% | 86.7% | All 95% confidence intervals for the differences were within +/-10 percentage points, indicating non-inferiority (abstract). Adverse events 23% with thyrotropin alfa versus 30% with hormone withdrawal (P=0.11). |
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 84.3% | 87.6% | The abstract does not give the ablation success rate for low-dose radioiodine with hormone withdrawal. |
| Endpoint | Analysis | Low-dose radioiodine (both stimulation methods pooled) / Thyrotropin alfa (both doses pooled) / Low dose with thyrotropin alfa / Low dose with hormone withdrawal / High dose with thyrotropin alfa | High-dose radioiodine (both stimulation methods pooled) / Thyroid hormone withdrawal (both doses pooled) / High dose with hormone withdrawal | Effect |
|---|---|---|---|---|
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 85% | 88.9% | All 95% confidence intervals for the differences were within +/-10 percentage points, indicating non-inferiority (abstract). Adverse events 21% with low dose versus 33% with high dose (P=0.007); hospitalisation for at least 3 days 13.0% versus 36.3% (P<0.001). |
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 87.1% | 86.7% | All 95% confidence intervals for the differences were within +/-10 percentage points, indicating non-inferiority (abstract). Adverse events 23% with thyrotropin alfa versus 30% with hormone withdrawal (P=0.11). |
| Ablation success ratePatients with analysable data (421 of 438 randomised) | primaryMallick 2012 | 84.3% | 87.6% | The abstract does not give the ablation success rate for low-dose radioiodine with hormone withdrawal. |