Efficacy Studies

Learn about the efficacy of Thyrogen as an adjunct to radioactive iodine (RAI) ablation and diagnostic testing

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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. To date, these are the 2 largest, prospective, multicenter, randomized studies performed in thyroid cancer.1,2

  • 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.

The two studies compared the following:

  • Safety and Ablation efficacy between patients prepared with Thyrogen and thyroid hormone withdrawal (THW)
  • Symptoms of acute hypothyroidism before, during, and after Thyrogen injections and thyroid hormone withdrawal (THW).
  • Recurrence rates 5 years after radioactive iodine treatment

What You Should Know About the Adult Patients in These Studies1,2

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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 Study1): Randomized 438 patients (tumor stages T1-T3, Nx, N0 and N1, M0)

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Successful remnant ablation rates (ESTIMABL Study2): randomized 752 low risk patients

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In a study with 63 patients, researchers evaluated the quality of life across eight areas using the SF-36 Scale.3

  • The Short-Form 36-Item Health Survey (SF-36) is a clinically validated assessment tool commonly used in clinical trials. A higher score indicates a better response.
  • The scores were taken at baseline, 2 weeks after randomization, and immediately before RAI ablation for all patients who were randomized into two trial arms: Thyrogen and thyroid hormone withdrawal (THW) plus 100 mCI radioactive iodine.
  • The Quality of Life in patients following Thyrogen administration improved in 7of 8 domains between baseline and week 4, whereas the THW group experienced a decrease in 7of 8 QOL measures.

Mean change in SF-36 scores from baseline to week 43

Patients prepared with Thyrogen improved in seven of eight physical and mental domains between baseline and week 4.

The Short-Form 36-Item Health Survey (SF-36) is a clinically validated assessment tool commonly used in clinical trials. A higher score indicates a better response.

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In the HiLO and ESTIMABL studies, Thyrogen patients had their cancer return at a similar rate as patients who underwent thyroid hormone withdrawal (THW) after radioactive iodine (RAI) ablation.4,5

Long-term follow-up results from 2 large studies (1150 patients) on thyroid cancer show that Thyrogen had similar results compared with THW for radioactive iodine ablation.

  • Cancer recurrence was similar across patients in the Thyrogen and THW groups.1,2
  • Overall patients receiving Thyrogen, demonstrated lower deterioration of HRQoL scores compared to those who experienced THW. This is because Thyrogen may help lower the symptoms associated with acute hypothyroidism.

Results of two clinical studies showed that at 5 years recurrence rates after RAI ablation are similar between Thyrogen and thyroid hormone withdrawal (THW)

In low-risk well differentiated thyroid cancer (WDTC) patients, less than 2% had their cancer return at 5 years4

In the ESTIMABL study with 726 patients who received RAI, outcomes were comparable in the different patient groups. Among the patients who had their cancer return, 7 (1.9%) received Thyrogen and 4 (1.1%) received THW.1

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In low to intermediate risk well differentiated thyroid cancer patients, cancer recurrence rates were similar between those who received Thyrogen vs THW at 5 years5

In the HiLO study with 438 patients who received RAI, disease recurrence rates were similar among patients in the Thyrogen group vs those in the THW group (2.1% vs. 2.7%).2

Percentage of patients with recurrence at 5 years

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Recurrence was similarly low

Thyrogen patients reported better physical and psychological function than those who experienced thyroid hormone withdrawal (THW)

Thyrogen patients had better quality of life compared with THW while undergoing preparation for ablation.

In the HiLo study with 438 patients, quality of life was evaluated at the time of consent, on the day of ablation before radioiodine administration, and 3 months after ablation.

Before ablation, among patients receiving Thyrogen, there were clear benefits as compared with those undergoing THW for physical and psychological functioning.4

Fewer Thyrogen patients reported having difficulty performing their usual activities at home and work

On the day of ablation, patients also completed a questionnaire about thyroid cancer–specific symptoms.

In patients reporting symptoms as either "moderate" or "a lot" fewer Thyrogen patients had difficulty performing usual household activities (13.2% vs 19.2%) or taking care of their children (8.1% vs 14.1%) compared to patients undergoing THW. Among the patients who were employed, fewer patients in the Thyrogen group had difficulty performing usual activities at work compared with the THW group (9.4% vs 22.1%).4

In the same study, out of 438 patients1

What You Should Know About the Adult Patients in These Diagnostic Studies5,6,7

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The two studies compared the following:6,7

  • Radioactive iodine whole body scans (WBS) obtained after THYROGEN injections and radioactive iodine whole body scans after thyroid hormone withdrawal (THW).
  • Combination of stimulated thyroglobulin (Tg) levels in the blood and WBS obtained after THYROGEN injections and after thyroid hormone withdrawal (THW).
  • Symptoms of acute hypothyroidism before, during, and after Thyrogen injections and thyroid hormone withdrawal (THW).

One of the studies with 229 patients, also compared the quality of life between the Thyrogen phase and the THW phase.7


RESULTS comparing patients who received THYROGEN with those prepared with thyroid hormone withdrawal for radioiodine Whole Body Scanning With or Without stimulated thyroglobulin blood testing6,7

Disease detection rates were found to be comparable to the scans after Thyrogen and scans after thyroid hormone withdrawal with or without thyroglobulin testing

A Thyrogen stimulated thyroglobulin detected 100% of patients with metastatic disease vs 79% of patients who received thyroglobulin testing without stimulation

In pooled studies from 6 clinical studies, the most common side effects in patients were nausea, headache, fatigue, vomiting, dizziness and asthenia.6

The Quality of Life in patients following Thyrogen administration in the trial remained similar to their scores before the start of the trial when they were still on thyroid hormone medication.

In one diagnostic study with 229 patients, researchers evaluated quality of life across eight areas using the SF-36 Scale.7

The SF-36 is a 36-item, patient- Best Health reported survey of patient health, consisting of eight scaled scores. The lower the score the more disability. The higher the score the less the disability.

The scores were taken at 3 points in time. At baseline while patients were still on their thyroid hormone medication, after administration of Thyrogen and after TWH on the day of RAI administration.

In this study, patients rated their QOL higher in all eight areas while using Thyrogen to prepare for RAI versus when they underwent THW in preparation for ablation. In fact, in this trial, with 229 patients, the quality of life differences in all eight domains was considered statistically significant.

SF-36 Health Survey Results in the Thyrogen Diagnostic Trial with 229 patients7

Quality of life differences in all eight domains was statistically significant

In two diagnostic studies, researchers evaluated the signs and symptoms of acute hypothyroidism in patients who received 2 injections of Thyrogen compared to by THW.6,7,8 The Billewicz scale was used.

A Billewicz scale is an observer-rated set of clinical findings that has been widely used in assessing hypothyroidism. Higher scores are associated with an increase in signs and symptoms of hypothyroidism.

Billewicz scores were taken at baseline while on thyroid hormone therapy, after administration of Thyrogen and after THW on day of RAI administration

Statistically significant worsening in all measured signs and symptoms were observed during the acute hypothyroid phase for patients undergoing THW

Thyrogen administration was associated with fewer signs and symptoms of hypothyroidism than those associated with thyroid hormone withdrawal as measured by the Billewicz scale.

  • Thyrogen is given as a 0.9 mg injection into the muscle of the buttock for two consecutive days
  • The most common side effects in patients getting Thyrogen were nausea, headache , fatigue, vomiting, dizziness and asthenia