Radioiodine Ablation of Thyroid Remnants After Preparation with Recombinant Human Thyrotropin

Robbins, Richard J.; Tuttle, R. Michael; Sonenberg, Martin; Shaha, Ashok R.; Sharaf, Renu N.; Robbins, H.; Fleisher, Martin; Larson, S. M.

doi:10.1089/105072501316973127

Cited by 92 publications

(56 citation statements)

References 20 publications

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“…This may include severe lethargy and fatigue,while enabling patients to remain euthyroid (7)(8)(9)(10). In addition, a multi-centre, randomised, controlled trial has directly compared the use of rhTSH preparation with the standard hypothyroid preparation, prior to remnant ablation with an activity of 3.7 GBq 131 I (11).…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective

Mernagh¹,

Campbell²,

Dietlein³

et al. 2006

eur j endocrinol

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Objective: This investigation evaluated the cost-effectiveness of radioiodine remnant ablation following preparation with recombinant human TSH (rhTSH), compared with the standard preparation, whereby patients are rendered hypothyroid. Design: The economic evaluation relates to patients with well differentiated thyroid cancer who have undergone thyroidectomy, but have no metastases. The evaluation takes a societal perspective, considering costs and benefits to all parties. The benefits were expressed in units of quality-adjusted life years (QALY), so differences in life expectancy were captured with consideration of quality of life. Methods: A lifetime Markov model with Monte Carlo simulation of 100 000 patients was used to assess cost per QALY gained. The clinical inputs were sourced from a multi-centre, randomised controlled trial comparing remnant ablation success after rhTSH-preparation with hypothyroid preparation. The model applied German unit costs, however, the structure is generalisable to other jurisdictions. The additional cost of rhTSH procurement and administration is considered relative to the clinical benefits and cost offsets. These included avoidance of hypothyroidism, increased work productivity, earlier discharge from radioprotection and a theoretical reduction in the risk of secondary malignancy. The latter two benefits relate to faster radioiodine clearance after rhTSH preparation. Results: The additional benefits of rhTSH (0.0495 QALY) are obtained with an incremental societal cost of V47, equating to an incremental cost per QALY of V958. Sensitivity analyses had only a modest impact upon cost-effectiveness, with all one-way sensitivity results remaining under V15 000/QALY. Conclusions: The use of rhTSH prior to radioiodine ablation represents good value-for-money with the benefits to patient and society obtained at modest net cost. 155 405-414 European Journal of Endocrinology

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Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective

Mernagh¹,

Campbell²,

Dietlein³

et al. 2006

eur j endocrinol

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“…The patient is placed back on levothyroxine suppressive therapy, as appropriate, and approximately 1 week after the treatment dose of RAI, a post-therapy WBS is performed to better assess for residual or metastatic disease. Substitution of rhTSH stimulation for TSH stimulation by THW for diagnostic evaluations (shown in Figure 2b and reviewed by Cooper et al (2006) or for thyroid remnant ablation (shown in Figures 1c and 1d), has been published by a number of centers, allowing patients to remain on levothyroxine therapy and avoid the symptoms of hypothyroidism (Robbins et al 2001;Robbins et al 2002b;Barbaro et al 2003;Barbaro et al 2006;Pacini et al 2006a;Pilli et al 2007;Rosario et al 2008;Taieb et al 2008;Tuttle et al 2008). Over the last 3 years, thyrotropin alfa (Thyrogen ® ) has been approved for RAI ablation by the United States Food and Drug Administration (FDA, 2007), in Europe (2005), and in certain Asian (2007) and South American countries (2006).…”

Section: Management Issues In Thyroid Cancer and Use Of Radioiodinementioning

confidence: 99%

Recombinant human thyroid stimulating hormone in 2008: focus on thyroid cancer management

Gramza

Schuff

2009

OTT

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Radioiodine (RAI) ablation following thyroidectomy is standard of care treatment for patients with intermediate or high risk differentiated thyroid cancer. Traditionally, this has been achieved by forgoing thyroid hormone replacement postoperatively, allowing endogenous thyroid stimulating hormone (TSH) levels to rise. This rise in TSH provides the stimulus for RAI uptake by the thyroid remnant, but is associated with clinical hypothyroidism and its associated morbidities. Recombinant human TSH (rhTSH, thyrotropin alfa [Thyrogen ® ], Genzyme Corporation, Cambridge, MA, USA) was developed to provide TSH stimulation without withdrawal of thyroid hormone and clinical hypothyroidism. Phase III studies reported equivalent detection of recurrent or residual disease when rhTSH was used compared with thyroid hormone withdrawal (THW). These trials led to its approval as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without RAI imaging in the surveillance of patients with differentiated thyroid cancer. Recently, rhTSH was given an indication for adjunctive preparation for thyroid remnant ablation after phase III studies demonstrated comparable outcomes for rhTSH preparation when compared with THW. Importantly, rhTSH stimulation has been found to be safe, well tolerated, and to result in improved quality of life. Here, we review the effi cacy and tolerability studies leading to the approval for the use of rhTSH in well-differentiated thyroid cancer management.

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“…Although a traditional method of preparation for the high-dose radioiodine therapy is thyroid hormone withdrawal (THW), nowadays, recombinant human thyroidstimulating hormone (rh-TSH) is increasingly used instead. It has also been proposed that rh-TSH stimulates iodine uptake via activation of the sodium-iodine symporter and leads to sufficient I-131 uptake in thyroid remnants to allow for complete remnant ablation [5].…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Influence on the Liver Function Between Thyroid Hormone Withdrawal and rh-TSH Before High-Dose Radioiodine Therapy in Patients with Well-Differentiated Thyroid Cancer

Han

Lim

Yun

et al. 2012

Nucl Med Mol Imaging

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Purpose An elevated thyroid stimulating hormone level (TSH) is essential to stimulate the uptake of radioiodine into thyroid remnants and metastases of thyroid cancer when a patient undergoes high-dose radioiodine therapy. Nowadays, recombinant human thyroid stimulating hormone (rh-TSH) is increasingly used instead of the classic method of thyroid hormone withdrawal (THW). However, beyond the therapeutic effects, clinical differences between the two methods have not yet been clearly demonstrated. The aim of this work was to investigate the effects of the two methods, especially on liver function. Methods We identified 143 evaluable patients who were further divided into two groups: THW and rh-TSH. We first reviewed the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels, which were measured during the admission period for total thyroidectomy. We called these liver enzyme levels "base AST" and "base ALT." We also assessed other chemistry profiles, including AST, ALT, total cholesterol, LDL cholesterol, alkaline phosphatase (ALP), total bilirubin (TB), and triglyceride (TG), which were measured on admission day for high-dose radioiodine therapy. We called these liver enzyme levels "follow-up AST" and "follow-up ALT." We compared the changes in base and follow-up liver enzyme levels and the other chemistry profiles between the two groups. Results The base AST and base ALT levels of the two groups were within normal range, and there was no significant difference between the two groups. In contrast to these base liver enzyme levels, follow-up liver enzyme levels between the two groups showed significant differences. Patients in the THW group had higher follow-up AST and ALT levels than did the rh-TSH group. Patients in the THW group also had higher levels of total cholesterol and LDL cholesterol than did the patients in the rh-TSH group. However there were no statistically significant differences in ALP, total bilirubin, and triglyceride levels between the two groups. Conclusions In this retrospective analysis of liver function, the use of rh-TSH for high-dose radioiodine therapy had less of an effect on liver function and cholesterol levels than dose thyroid hormone withdrawal. This suggests that rh-TSH can be used effectively and safely especially for patients with metabolic syndrome.

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Radioiodine Ablation of Thyroid Remnants After Preparation with Recombinant Human Thyrotropin

Cited by 92 publications

References 20 publications

Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective

Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective

Recombinant human thyroid stimulating hormone in 2008: focus on thyroid cancer management

Comparison of the Influence on the Liver Function Between Thyroid Hormone Withdrawal and rh-TSH Before High-Dose Radioiodine Therapy in Patients with Well-Differentiated Thyroid Cancer

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