Radioiodine ablation in thyroid cancer patients: comparison of length and cost of hospital stay between preparation by thyroid hormone withdrawal and Thyrogen
Treatment of thyroid cancer consists of thyroidectomy and radioiodine ablation following thyroid-stimulating hormone (TSH) stimulation. Similar ablation rates were obtained with either thyroid hormone withdrawal (THW) or rhTSH. But with rhTSH, the elimination of radioiodine is more rapid, thus reducing its whole-body retention and potentially resulting in a shorter hospital stay. The aim of this study was to assess the financial impact of a reduced length of hospital stay with the use of rhTSH.
This was a case-control study of thyroid cancer patients treated postoperatively with 3,700 MBq (100 mCi) radioiodine; 35 patients who received rhTSH were matched with 64 patients submitted to THW according to covariates influencing radioiodine retention. The length of hospitalization (LOH) was estimated for each method according to the threshold of radioiodine retention below which the patient can be discharged from the hospital. The economic analysis was conducted from a hospital perspective. Simulations were performed.
For a threshold of 400 MBq, the LOH was 2.4 days and 3.5 days with rhTSH and THW, respectively, and the cost for an ablation stay was, respectively, 2,146 and 1,807 . In the French context, 57% of the acquisition cost of rhTSH was compensated by the reduction of the length of hospitalization.
By increasing the iodine excretion, rhTSH allows a shorter hospitalization length, which partially compensates its acquisition cost.
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- "Three randomized controlled clinical trials 4–6 were included. Trial durations were from December 2001 to July 2010 in two trials 5–6; the duration was not mentioned in one trial 4. Four RCTs comparing rhTSH-aided versus THW-aided radioiodine remnant ablation 7–10, eight historical case–control studies 11–18, and four nonrandomized prospective controlled clinical trials 19–22 on rhTSH -aided 131I thyroid remnant ablation were excluded. "
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ABSTRACT: The effects of low-activity versus high-activity radioiodine regimens in thyroid remnant ablation for patients with differentiated thyroid carcinoma (DTC) under recombinant human thyrotropin (rhTSH) stimulation have been widely quoted but there has been no systematic review of the evidence. We undertook a systematic review of randomized controlled trials to assess the effects of low-activity radioiodine in thyroid remnant ablation in patients with DTC under rhTSH stimulation compared with high-activity radioiodine. Studies were obtained from computerized searches of MEDLINE, EMBASE, and the Cochrane Library (all until September 2012). Randomized controlled trials were included. Altogether, 637 patients with DTC who participated in three trials for residual ablation were included. Overall, studies had a low risk of bias. We found no statistically significant differences between low-activity (1.11/1.85 GBq) and high-activity (3.7 GBq) radioiodine treatment aided by rhTSH in terms of successful ablation rates on the basis of diagnostic scans [odds ratio (OR) 0.85, 95% confidence interval (CI) 0.49-1.47, P=0.56], thyroglobulin levels (OR 0.66, 95% CI 0.38-1.15, P=0.14), and health-related quality of life (mean difference 0.07, 95% CI -0.96 to 1.09, P=0.9). In addition, the subgroup analysis of 1.11 versus 3.7 GBq (OR 0.83, 95% CI 0.46-1.49, P=0.53) and 1.85 versus 3.7 GBq (OR 1, 95% CI 0.23-4.35, P=1) also showed no significant differences. The lower activity of 1.11 GBq showed significant benefit in terms of reduction in adverse events including neck pain, radiation gastritis, and salivary dysfunction during and after ablation (OR 0.63, 95% CI 0.42-0.93, P=0.02). Limited data from three randomized controlled trials suggested that an rhTSH-aided low radioiodine activity level of as low as 1.115 GBq may be sufficient for thyroid remnant ablation when compared with 3.7 GBq, with fewer common adverse effects in patients with metastasis-free DTC. Further evidence is needed to confirm the effects of low-activity radioiodine for thyroid remnant ablation. Radioiodine treatment of 1.11 GBq showed significant benefit in terms of reduction in adverse events including neck pain, radiation gastritis, and salivary dysfunction during and after ablation (OR 0.63, 95% CI 0.42-0.93, P=0.02). rhTSH-aided low radioiodine activity levels of 1.11 and 1.85 GBq are sufficient for thyroid remnant ablation as compared with 3.7 GBq, with fewer common adverse effects in patients with metastasis-free DTC. A well-designed study that compares low-activity with high-activity radioiodine ablation is needed to fully understand the long-term adverse effects and relapse or metastases.
Available from: Harald Schrem
- "The ability to substitute pituitary TSH by recombinant TSH uncouples the radio ablative treatment (RAT) from hypothyroidism and facilitates RAT in euthyroidism under full-scale L-T 4 substitutive medication. The socioeconomic advantages of RAT in euthyroidism are a sustained quality-of-life and a significantly reduced number of sick-leave days    and it has been shown that rhTSH preconditioning is as effective and safe as preconditioning by hypothyroidism    . Here we present long-term follow-up data of a randomized clinical trial comparing the efficacy of RAT after preconditioning by rhTSH with hypothyroidism. "
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ABSTRACT: Introduction. Differentiated thyroid cancer treatment usually consists of thyroidectomy and radio ablation in hypothyroidism 4-6 weeks after surgery. Replacing hypothyroidism by recombinant human thyroid stimulating hormone can facilitate radio ablation in euthyroidism within one week after surgery. The outcome of this approach was investigated. Methods. This is a prospective randomized trial to compare thyroidectomy and radio ablation within a few days after preconditioning with recombinant human thyroid stimulating hormone versus thyroidectomy and radio ablation separated by four weeks of L-T4 withdrawal. Tumors were graded into very low-, low- , or high-risk tumors. Recurrence-free survival was confirmed at follow-up controls by neck ultrasound and serum thyroglobulin. Suspected tumor recurrence was treated by additional radio ablation or surgery. Quality-of-life questionnaires with additional evaluation of job performance and sick-leave time were used in all patients. Results. Radio ablation in euthyroidism in quick succession after thyroidectomy did not lead to higher tumor recurrence rates of differentiated thyroid cancers in any risk category and was significantly advantageous with respect to quality-of-life (P < 0.001), sick-leave time (P < 0.001), and job performance (P = 0.002). Conclusion. Recombinant human thyroid stimulating hormone can be used safely and with good efficacy to allow radio ablation under sustained euthyroidism within one week after thyroidectomy.
Available from: PubMed Central
- "The modeled simulations predicted a length of stay of 2.4 days for patients who received rhTSH preparation compared to 3.5 days for THW preparation (p < 0.001). This resulted in a savings of 338, which would defray approximately half the cost of thyrotropin alfa administration (Borget et al 2008). "
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ABSTRACT: 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 efficacy and tolerability studies leading to the approval for the use of rhTSH in well-differentiated thyroid cancer management.
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