Remnant Ablation

Thyrogen in Remnant Ablation

With the use of Thyrogen, patients continue with thyroid hormone replacement therapy and remain euthyroid.

Initial therapy for most patients with well-differentiated thyroid cancer is total or near-total thyroidectomy. Thyroidectomy can be followed by radioiodine (131I) thyroid remnant ablation.

Remnant ablation is used to destroy residual thyroid tissue (cancerous and non-cancerous), which may decrease clinical tumor recurrence and facilitate long-term surveillance with stimulated thyroglobulin measurements or whole-body scans.

Elevated levels of thyroid stimulating hormone (TSH) are required to promote adequate 131I uptake. Increasing TSH levels can be accomplished with 2 different approaches: thyroid hormone withdrawal or administration of Thyrogen (see Clinical Pharmacology). 

Clinical trial results have shown that administration of Thyrogen is as effective as thyroid hormone withdrawal for remnant ablation.

Clinical Trial Results with Thyrogen1-4

Four studies were performed to evaluate Thyrogen’s efficacy and long-term success rates in remnant ablation, compared to thyroid hormone withdrawal (THW).

Ablation success rates in 2012 studies1,2

  • Thyrogen was compared with THW using 2 different doses of radioiodine in patients with well-differentiated thyroid cancer who had undergone thyroidectomy in 2 large, 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. 
  • Ablation success rates were assessed at approximately 8 months.

Ablation success with Thyrogen vs thyroid hormone withdrawal1,2

image

a In study A, ablation success was defined as radioiodine uptake of <0.1% in the thyroid bed and stimulated thyroglobulin levels of <2.0 ng/mL.
b In study B, ablation success was defined by neck ultrasound and stimulated thyroglobulin of ≤1.0 ng/mL.

Long-term Results with Thyrogen3,4

As a follow-up to an early study of the efficacy of Thyrogen compared to THW,3 an additional study showed that long-term success (median 3.7 years) of remnant ablation with Thyrogen is equivalent to that achieved with THW.4

Study Design:

An international, randomized, controlled, multicenter trial compared the success rate of thyroid remnant ablation achieved after preparation with thyroid hormone withdrawal (n=30) was compared to the success rate achieved after preparation with Thyrogen (n=33).

Study Patients:

  • ≥18 years of age with newly diagnosed differentiated papillary or follicular thyroid carcinoma
  • Patients were staged as T2 or T4, with minor invasion of the thyroid capsule, N0-N1, and M0 or T0-T1, N1, and M0

Post-thyroidectomy radioiodine ablation in well-differentiated thyroid cancer: comparison of short- and long-term (median 3.7-years) success with thyroid hormone withdrawal and Thyrogen3,4

image

a Defined as no visible uptake or uptake <0.1% by diagnostic whole-body scan.

None of the 51 patients declared disease free at the 8-month follow-up had evidence of tumor recurrence at subsequent follow-up.

References

  1. Mallick U, Harmer C, Yap B, et al. Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer. N Engl J Med. 2012;366:1674-1685.
  2. Schlumberger M, Catargi B, Borget I, et al. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012;366:1663-1673.
  3. Pacini F, Ladenson PW, Schlumberger M, et al. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinomas: results of an international, randomized, controlled study. J Clin Endocrinol Metab. 2006;91:926-932.
  4. Elisei R, Schlumberger M, Driedger A, et al. Follow-up of low-risk differentiated thyroid cancer patients who underwent radioiodine ablation of postsurgical thyroid remnants after either recombinant human thyrotropin or thyroid hormone withdrawal. J Clin Endocrinol Metab. 2009;94:4171-4179.

INDICATIONS AND USAGE
Thyrogen is a thyroid stimulating hormone indicated for:

Diagnostic: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.

Limitations of Use:
Thyrogen-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal. Even when Thyrogen-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease. Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable.

Ablation
: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.

Limitations of Use:
The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.

Financial assistance is available for eligible patients

Learn more about our Financial Assistance Programs or download the Financial Assistance Sheet

Questions? Contact a ThyrogenONE case manager at 1-88-THYROGEN (1-888-497-6436)

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Thyrogen® (thyrotropin alfa for injection) 0.9 mg/mL after reconstitution

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of Thyrogen.

Caution should be exercised in patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, specifically in the elderly and those with a known history of heart disease.

Hospitalization for administration of Thyrogen and post-administration observation in patients at risk should be considered.

There are post marketing reports of stroke in young women with risk factors for stroke, and neurological findings suggestive of stroke (e.g., unilateral weakness) occurring within 72 hours of Thyrogen administration in patients without known central nervous system metastases.

Patients should be well-hydrated prior to treatment with Thyrogen.

Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with Thyrogen.

Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.

ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials were nausea and headache.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C: Animal reproduction studies have not been conducted with Thyrogen. It is also not known whether Thyrogen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Thyrogen should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thyrogen is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Results from controlled trials do not indicate a difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those over 65 years of age.

Renal Impairment: Elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease patients, resulting in prolonged elevation of TSH levels.

INDICATIONS AND USAGE

Thyrogen is a thyroid stimulating hormone indicated for:

Diagnostic: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.

Limitations of Use:

  • Thyrogen -stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.
  • Even when Thyrogen -Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.
  • Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable.

Ablation: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.

Limitations of Use:

  • The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.

See full Prescribing Information for more details.