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Diagnostic Follow up

Although the five-year survival rate for most patients with well differentiated thyroid cancer is approximately 97%, recurrences occur in approximately 30% of patients. Of all recurrences, one third may only become evident 10 or more years after initial treatment.¹ Given that most thyroid cancer is diagnosed in relatively young patients (20-50 years old), the routine follow-up of these patients is important.

According to the American Thyroid Association,² accurate surveillance for possible recurrence in patients thought to be free of disease is a major goal of long-term follow up.

Diagnostic follow-up modalities include serum thyroglobulin levels, diagnostic whole body scans (WBS), post-treatment WBS, ultrasonography, and other imaging methods. Measurement of serum Thyroglobulin (Tg) levels is an important diagnostic test in the management of patients with well differentiated thyroid cancer (WDTC).² Serum thyroglobulin has a high degree of sensitivity and specificity to detect thyroid cancer, especially after total thyroidectomy and remnant ablation. The highest degrees of sensitivity are noted after thyroid hormone withdrawal or stimulation using rhTSH (Thyrogen).²

Thyrogen^® (thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up patients with well-differentiated thyroid cancer.

In the menu called Clinical Summary- Diagnostic Follow-up you will find information on the clinical evidence for use of Thyrogen in diagnostic follow-up of WDTC.

REFERENCES:

1. Mazzaferri EL An overview of the management of papillary and follicular thyroid carcinoma. Thyroid. 1999; 9:421–427.

2. Cooper D, Doherty G, Haugen B, Kloos R, Lee S, Mandel S. Guidelines for patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association Guidelines Taskforce. Thyroid. 2006; 16:109-142.

Patient stories

As a result of withholding or removing thyroid hormone replacement the effects of hypothyroidism can vary. In some cases, the symptoms may be minor, while for others, the symptoms can be more significant.

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Indication
Thyrogen (thyrotropin alfa for injection) is indicated for 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.

Thyrogen (thyrotropin alfa for injection) is indicated for 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 metastatic thyroid cancer.

Important Safety Information

When Thyrogen-stimulated serum thyroglobulin (Tg) testing is performed in combination with radioiodine imaging, there remains a meaningful risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.
Although Thyrogen appeared non-inferior to thyroid hormone withdrawal in a study of postsurgical thyroid remnant ablation, long-term clinical outcome data are limited. Due to relatively small clinical experience with Thyrogen in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of Thyrogen or hormone withdrawal for TSH elevation prior to remnant ablation.
Caution should be exercised in patients with a known history of heart disease and with significant residual thyroid tissue. Careful evaluation of benefit risk should be assessed for high risk elderly patients with functioning thyroid tumors undergoing Thyrogen administration, to avoid palpitations or cardiac rhythm disorder.
It is recommended that pretreatment with glucocorticoids be considered for patients in whom local tumor expansion may comprise vital anatomic structures (such as trachea, central nervous system, or extensive macroscopic lung metastases).
In clinical studies, the most common side effects reported were nausea, headache, fatigue, vomiting, dizziness, paraesthesia, asthenia, insomnia, and diarrhea.

Please see accompanying full Prescribing Information.