Efficacy Results in Diagnostic Testing
Allow patients to remain euthyroid in diagnostic follow up using stimulated Tg Testing with or without a Whole-Body Scan1
Comparing Thyrogen with THW in Tg Testing1
Study Design
- In a prospective, randomized, phase 3 clinical trial with a cross-over, nonblinded design, 229 patients with well-differentiated thyroid cancer who had undergone total or near-total thyroidectomy were studied to compare whole body scans. Each patient was scanned first using THYROGEN, then scanned using thyroid hormone withdrawal. Tg levels were compared after Thyrogen to those at baseline and to those after thyroid hormone withdrawal (THW)1,2
- Patients who were included in the Tg analysis were those who had undergone total or near-total thyroidectomy with or without 131I ablation, had < 1% uptake in the thyroid bed on a scan after thyroid hormone withdrawal, and did not have detectable anti-Tg antibodies.1,2
- The maximum Thyrogen Tg value was obtained 72 hours after the final Thyrogen injection, and this value was used in the analysis.1,2
Stimulated Tg versus non stimulated Tg testing
Approximately 1 in 5 metastatic disease positives were missed with non stimulated Tg testing2
Among patients with metastatic disease confirmed by a post treatment scan or by lymph node biopsy (35 patients), Thyrogen Tg was positive (≥2.5 ng/mL) in all 35 patients, while Tg on thyroid hormone suppressive therapy was positive (≥2.5 ng/mL) in 79% of these patients.2
As with THW, the intrapatient reproducibility of Thyrogen testing with regard to both Tg stimulation and radio iodine imaging has not been studied.
Uptake comparable in whole body scan (WBS)
Study Design
- Two prospective, randomized, phase 3 clinical trials with a cross-over, nonblinded design, were conducted in patients with well differentiated thyroid cancer to compare 131I WBS’s obtained after Thyrogen injection to 131I WBS’s after THW. In both studies, the primary endpoint was the rate of comparable scan.2
- Across the two clinical studies the majority of positive scans using Thyrogen and THW were comparable.2
- The use of Thyrogen in preparation for WBS was comparable to THW in both efficacy and safety for stimulating the uptake of radioactive iodine (RAI).3
- Patients with residual thyroid tissue at risk for Thyrogen-induced hyperthyroidism include the elderly and those with a known history of heart disease.2
Choose how to get Thyrogen® (thyrotropin alfa) for injection for your patients
Not sure which one to choose? Contact ThyrogenONE® for assistance
Option 2: Call ThyrogenONE at 1-88-THYROGEN (1-888-497-6436)
Dedicated ThyrogenONE Case Managers can assist you and your patients with the following:
- Benefits Verification
- Information on Ordering
- Information on specialty pharmacy fulfillment
Important Safety Information
References
1) Haugen BR, Pacini F, Reiners C, et al. A comparison of recombinant human thyrotropin and thyroid hormone withdrawal for the detection of thyroid remnant or cancer. J Clin Endocrinol Metab. 1999;84(11):3877-3885.
2) Thyrogen Prescribing Information. Cambridge, MA: Genzyme Corp; Feb 2023.
3) Hänscheid H, Lassmann M, Luster M, et al. Iodine biokinetics and dosimetry in radioiodine therapy of thyroid cancer: procedures and results of a prospective international controlled study of ablation after rhTSH or hormone withdrawal. J Nucl Med. 2006;47(4):648-654.