Efficacy in Radioactive Iodine Ablation (RAI)

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Thyrogen was compared with THW using 2 different doses of radioiodine in patients with well-differentiated thyroid cancer who had undergone thyroidectomy in the 2 largest, prospective, multicenter, randomized studies performed in thyroid cancer.

  • In both studies, patients were randomized to 1 of 4 treatment groups: Thyrogen + 30 mCi, Thyrogen + 100 mCi, THW + 30 mCi, THW +100 mCi. There was no difference in the treatment success rates between the 2 doses of radioiodine.
  • Ablation success rates were assessed at approximately 8 months
  • In the HiLo trial, ablation success was defined as radioiodine uptake of <0.1% in the thyroid bed and stimulated thyroglobulin levels of <2.0 ng/mL.
  • In the ESTIMABL trial, ablation success was defined by neck ultrasound and stimulated thyroglobulin of ≤1.0 ng/mL.

ESTIMABL and HiLO Trials1,2

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Ablation Success at 8 Months: Data from the 2 largest, randomized clinical trials in differentiated thyroid cancer1,2

Successful remnant ablation rates (HiLo study)1: Randomized 438 patients (tumor stages T1-T3, Nx, N0 and N1, M0)

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Successful remnant ablation rates (ESTIMABL study)2: randomized 752 low risk patients

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  • 1In the HiLO Study, ablation success was defined as radioiodine uptake of <0.1% in the thyroid bed and stimulated thyroglobulin levels of <2.0 ng/mL.
  • 2In the ESTIMABL Study, ablation success was defined by neck ultrasound and stimulated thyroglobulin of ≤1.0 ng/mL.

Efficacy Results in Radioactive Iodine Ablation (RAI) - 5 year update from the Estimabl and HiLO trials.

Patients receiving Thyrogen had similar recurrence rates as thyroid hormone withdrawal (THW) 5 years post radioiodine remnant ablation3,4

Long term follow up results from 2 large, non-inferiority randomized clinical trials on thyroid cancer demonstrated that American Thyroid Association (ATA) low and intermediate risk patients prepared with Thyrogen for radioactive iodine ablation (RAI) had similar recurrence rates as patients who were prepared with thyroid hormone withdrawal.1,2 Results were also not significantly different between low (30 mCi) and high (100 mCi) dose groups.1,2

A significantly higher proportion of patients in the THW groups exhibited HRQoL deterioration at radioiodine administration compared with the Thyrogen groups. Overall, Thyrogen patients had significantly lower deterioration of HRQoL compared with THW.3,4

5 years post RAI ablation, clinical findings suggest that disease recurrence was not related to the method used to prepare the patient for RAI ablation.3

Comparable outcomes were observed in the patient groups, 98.1% of patients remained recurrence free in the Thyrogen group vs 98.9% in the THW group.

In the ESTIMABL1 Outcomes Study3
Schlumberger M, et al
(726 evaluable patients)

Percentage of patients recurrence free at 5 years

ESTIMABL1 is an open-label, randomized trial involving 752 patients. All patients were randomly assigned (1:1:1:1) to 30 mCi or 100 mCi radioactive iodine dose, each prepared with either Thyrogen or THW. Follow-up consisted of a yearly serum thyroglobulin measurement on levothyroxine treatment. The median follow-up was 5.4 years. No evidence of disease was defined as serum thyroglobulin of ≤1 ng/mL on levothyroxine treatment and normal results on neck ultrasonography.

Thyrogen combinations with RAI had similar recurrence rates vs THW regardless of radioactive iodine dose.3

Thyrogen and low-dose radioactive iodine was as effective as high-dose radioactive iodine combinations. No significant difference (P>0.05) was observed between the radioactive iodine ablation strategy and the number of abnormalities observed.

In the ESTIMABL1 Outcomes Study3
Schlumberger M, et al
(726 evaluable patients)

Percentage of patients with persistent disease at last follow-up

In ATA low to intermediate risk patients

In patients with low to intermediate risk thyroid cancer, Thyrogen like THW, had no apparent impact on the efficacy of ablation based on recurrence rates.4

Recurrence rates were similar among patients who were prepared for ablation with Thyrogen vs those prepared with THW (2.1% vs 2.7%).

In the HiLo Study4
Dehbi H, et al
(434 evaluable patients)

Cumulative recurrence rate at 5 years.

HiLo is a non-inferiority, parallel, open-label, randomized controlled factorial rial involving 438 patients. Patients were randomly assigned (1:1:1:1) to 30 mCi or 100 mCi ablation, each prepared with either Thyrogen or THW. The edian follow-up was 6.5 yrs. Patients were followed up at annual clinic visits. ecurrence was defined as any evidence of (usually structural) disease dentified during follow-up.2

Disease recurrence was not related to the radioactive iodine doses used in the study, even in intermediate risk patients (T3, N1).4

Despite inclusion of intermediate-risk patients (T3 or N1) in the study population, recurrence rates were similar across the low and high dose radioactive iodine groups (2.1% vs 2.7%).

In the HiLo Study4
Dehbi H, et al
(434 evaluable patients)

Cumulative recurrence rate at 5 years.

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