The Use of Thyrogen<sup>®</sup> in the Treatment of Differentiated Thyroid Carcinoma: An Intraindividual Comparison of Clinical Effects and Implications of Daily Life

Dueren, Christian; Dietlein, Markus; Luster, Markus; Plenzig, F.; Steinke, R.; Grimm, J.; Groth, Peter; Eichhorn, Waltraud; Reiners, Christoph

doi:10.1055/s-0029-1234086

Cited by 23 publications

(21 citation statements)

References 17 publications

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“…The effect on QOL has been described in 9 previous trials (table 4) involving more than 2,000 patients: 1 study presents data based on a questionnaire [14], 3 studies are prospective longitudinal open trials [9,10,15] and 5 are randomised open label trials [8,16,17,18,19]. However, none of these trials were blinded and QOL, in most of the studies, was measured as a secondary outcome.…”

Section: Discussionmentioning

confidence: 99%

“…By this method it is possible to reduce the THW period from 3-4 weeks to 10-14 days, and still achieve the intended s-TSH of more than 30 mU/l [12]. Three trials have compared QOL using L-T 4 THW alone versus bridging with L-T 3 and a shorter THW period [9,15,25]. Dueren et al [9] compared 72 patients in whom a period of L-T 3 bridging was used and a THW of L-T 3 for 2-3 weeks was compared with L-T 4 THW for 4-5 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…rh-TSH is therefore used for RI ablation therapy as well as to stimulate thyroglobulin secretion and iodine uptake for diagnostic purposes [8,9,10,11,12,13,14,15,16,17,18,19]. …”

Section: Introductionmentioning

confidence: 99%

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A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

Nygaard¹,

Bastholt²,

Bennedbæk³

et al. 2013

Eur Thyroid J

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Background: It is well known that thyroid hormone withdrawal (THW) in thyroid cancer patients can induce a decrease in quality of life (QOL). Recombinant human thyrotropin (rh-TSH) has been used to avoid this; however, no blinded studies have ever documented the effect. Objective: To compare QOL in patients with differentiated thyroid cancer (DTC) treated with either rh-TSH or liothyronine (L-T₃) THW for 10 days. Study Design: Double-blind, randomised cross-over. Patients: Fifty-six patients with DTC treated by total thyroidectomy and indication for postsurgery radioiodine (RI) ablation therapy. Intervention: Randomisation to either L-T₃ and rh-TSH prior to the first RI course and following this to ingest placebo tablets and receive placebo injections before a second RI uptake measurement 4-6 months later, or to receive placebo before the primary RI ablation and active therapy 4-6 months later. Main Outcome Measures: QOL was measured by SF-36 and 2 visual analogue scale (VAS) scores at baseline and during RI therapy or RI uptake. Results: A significant difference in QOL was seen in 2 of 4 predefined SF-36 domains (7.2 and 6.6%) and 2 VAS scales (10 and 14%), favouring rh-TSH therapy. Conclusion: This is the first blinded randomised clinical trial describing the effect of rh-TSH compared to L-T₃ THW on QOL in DTC patients. A significant difference was demonstrated, though smaller than described in previous non-blinded studies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

Nygaard¹,

Bastholt²,

Bennedbæk³

et al. 2013

Eur Thyroid J

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“…In a strict analogy and despite their paramount importance, we excluded societal benefits such as productivity gains in the base case analysis. This might be counterintuitive given the considerable body of evidence suggesting that endogenous stimulation results in greater work absenteeism [4,28,32,33]. Albeit not in ablation but in the follow up, Dietlein et al [28] reported workday loss in 70% of THW patients in follow-up (40% with Thyrogen ® ); Luster et al [4], back in 2005, reported a similar figure (65%).…”

Section: Sensitivity Analysismentioning

confidence: 99%

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

Danieli

Monari

Lazzarini

et al. 2016

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BACKGROUND: Radioiodine ablation is an adjuvant procedure used to treat patients with differentiated thyroid cancer. For ablation to be successful, patients must have elevated levels of thyroid stimulating hormone (TSH). This can be achieved by withholding thyroid hormone therapy (endogenous stimulation), or by administration of recombinant human thyroid stimulating hormone (rhTSH; Thyrogen®; exogenous stimulation) to patients in the euthyroid state.AIM: To compare the estimated health benefits, cost and cost-effectiveness of TSH stimulation with and without Thyrogen® in the Italian setting.METHODS: A cost-utility analysis was undertaken to assess the impact of exogenous vs. endogenous TSH stimulation before radioiodine remnant ablation of patients with newly diagnosed, well-differentiated papillary or follicular thyroid cancer who have undergone total or near-total thyroidectomy. A Markov model was developed to simulate treatment costs and health outcomes associated with exogenous and endogenous stimulation in four distinct health states: pre-ablation, ablation, post-ablation, and well/recovery. Treatment was stratified by patients who receive high- and low-activity (30-100 mCi, respectively) in the ablation state. The Italian National Health System perspective was adopted in the base case scenario while the impact of indirect costs was explored in a sensitivity analysis. Costs and quality-adjusted life years (QALY) specific to each health state were estimated, summarized and converted into a corresponding incremental cost-effectiveness ratio (ICER).RESULTS: We calculated a cost-effectiveness ratio of 18,357.18 €/QALY gained whereas the inclusion of indirect cost and accident cost produced reductions of the ICER to € 14,609.51 and € 15,515.26 per QALY, respectively. Finally, all results in the sensitivity analysis are below the lower bound of national and international cost- effective threshold.CONCLUSION: Thyrogen® represents a cost-effective option for patients with differentiated thyroid cancer who underwent total or near-total thyroidectomy in Italy. Our findings are consistent with other cost-utility analyses.

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“…QOL scores are lower during THW at the time of ablation compared to euthyroid recombinant human TSH (rhTSH)-prepared patients or controls (21,22,(25)(26)(27)(28)(29)(30)(31)(32). Finding the minimal duration and/or degree of hypothyroidism for adequate Tg stimulation testing may minimize the impact on QOL for patients undergoing THW.…”

mentioning

confidence: 99%

In Thyroidectomized Patients with Thyroid Cancer, a Serum Thyrotropin of 30 μU/mL After Thyroxine Withdrawal Is Not Always Adequate for Detecting an Elevated Stimulated Serum Thyroglobulin

Valle

Baskin

Porter

et al. 2013

Thyroid

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Background: The thyrotropin (TSH) level or duration of thyroid hormone withdrawal (THW) required to detect stimulated thyroglobulin (Tg) in differentiated thyroid cancer (DTC) monitoring is unknown. The objective of this study was to evaluate the TSH cutoff of > 30 lU/mL as a means to detect stimulated Tg ‡ 2 ng/mL after THW (THW-Tg ‡ 2), and sensitivity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire for detecting hypothyroid symptoms. Methods: This was a prospective longitudinal cohort study done at a tertiary academic medical center. Fortyseven patients with DTC undergoing their first Tg stimulation or after previously abnormal Tg stimulation had weekly measurements of TSH and Tg during the 4 weeks THW, and repeated questionnaire assessments. Results: TSH did not reach a plateau in any patient, and in those whose Tg did not remain undetectable, Tg continued to rise. Seventy-five percent of patients had an undetectable Tg < 0.2 ng/mL at baseline (95% were < 0.5 mg/mL) with 16% remaining undetectable throughout THW. The majority of patients (72.7% and 97.8%) achieved TSH > 30 lU/mL by 3 and 4 weeks THW, respectively. Of the 15 patients with maximum stimulated THW-Tg ‡ 2, 38% were detected before the minimal TSH > 30 lU/mL cutoff. At 2 weeks THW, 3 had a TSH > 30 lU/mL, and none of them had Tg ‡ 2 ng/mL. At 3 weeks THW, 11 had a TSH > 30 lU/mL, and 64% of them had Tg ‡ 2 ng/mL. Only 60% were detected at 3-week THW regardless of their TSH level. Eighty-six percent were detected by TSH 60-< 80 lU/mL. Conversely, all patients whose serum Tg was < 0.2 ng/mL when their serum TSH was > 20 lU/mL did not achieve a THW-Tg ‡ 2. Conclusion: The minimal TSH cutoff of > 30 lU/mL was inadequate to detect many patients with final stimulated THW-Tg ‡ 2 during complete THW. TSH > 80-100 lU/mL was a better cutoff, achieved in only 53% after 4-week THW. Conversely, we propose a preliminary THW-stopping rule for ending THW early in selected patients. In patients with a Tg < 0.2 ng/mL when TSH > 20 lU/mL, all had a final stimulated Tg £ 2 ng/mL, potentially saving qualifying patients 40% of THW duration compared to 4-week THW. FACIT-F correlated with TSH, but was not sensitive to detect mild hypothyroidism.

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The Use of Thyrogen^® in the Treatment of Differentiated Thyroid Carcinoma: An Intraindividual Comparison of Clinical Effects and Implications of Daily Life

Abstract: Included patients benefited subjectively and objectively from the use of rhTSH for diagnostic procedures in the treatment of DTC. A clear preference (127 of 128) of analyzed patients could be identified for exogenous stimulation with rhTSH.

Cited by 23 publications

References 17 publications

A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

In Thyroidectomized Patients with Thyroid Cancer, a Serum Thyrotropin of 30 μU/mL After Thyroxine Withdrawal Is Not Always Adequate for Detecting an Elevated Stimulated Serum Thyroglobulin

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The Use of Thyrogen® in the Treatment of Differentiated Thyroid Carcinoma: An Intraindividual Comparison of Clinical Effects and Implications of Daily Life

Abstract: Included patients benefited subjectively and objectively from the use of rhTSH for diagnostic procedures in the treatment of DTC. A clear preference (127 of 128) of analyzed patients could be identified for exogenous stimulation with rhTSH.

Cited by 23 publications

References 17 publications

A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy

In Thyroidectomized Patients with Thyroid Cancer, a Serum Thyrotropin of 30 μU/mL After Thyroxine Withdrawal Is Not Always Adequate for Detecting an Elevated Stimulated Serum Thyroglobulin

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The Use of Thyrogen^® in the Treatment of Differentiated Thyroid Carcinoma: An Intraindividual Comparison of Clinical Effects and Implications of Daily Life