Recombinant TSH stimulated remnant ablation therapy in thyroid cancer: the success rate depends on the definition of ablation success--an observational study

• Published in: PloS one 2015-03, Vol.10 (3), p.e0120184-e0120184
• Main Authors: van der Horst-Schrivers, Anouk N A, Sluiter, Wim J, Muller Kobold, Anneke C, Wolffenbuttel, Bruce H R, Plukker, John T M, Bisschop, Peter H, de Klerk, John M, Al Younis, Imad, Lips, Paul, Smit, Jan W, Brouwers, Adrienne H, Links, Thera P
• Format: Article
• Language: English
• Subjects: Ablation; Ablation (Surgery); Adult; Aged; Analysis; Cancer; Cancer research; Cancer therapies; Cancer treatment; Clinical trials; Confidence intervals; Contrast agents; Endocrinology; Failure analysis; Female; Health aspects; Humans; Hypothyroidism; Internal medicine; Iodine; Iodine 131; Iodine radioisotopes; Male; Middle Aged; Nuclear medicine; Observational studies; Patients; Pretreatment; Prospective Studies; Randomized Controlled Trials as Topic; Success; Surgery; Therapy; Thyroglobulin - metabolism; Thyroid; Thyroid cancer; Thyroid gland; Thyroid Gland - pathology; Thyroid Gland - surgery; Thyroid Neoplasms - pathology; Thyroid Neoplasms - surgery; Thyroid-stimulating hormone; Thyroidectomy; Thyrotropin; Thyrotropin - therapeutic use; Treatment Outcome; Triiodothyronine
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0120184

Patients with differentiated thyroid cancer (DTC) are treated with (near)-total thyroidectomy followed by remnant ablation. Optimal radioiodine-131 (131I) uptake is achieved by withholding thyroid hormone (THW), pretreatment with recombinant human Thyrotropin Stimulating Hormone (rhTSH) is an alternative. Six randomized trials have been published comparing THW and rhTSH, however comparison is difficult because an uniform definition of ablation success is lacking. Using a strict definition, we performed an observational study aiming to determine the efficacy of rhTSH as preparation for remnant ablation. Adult DTC patients with, tumor stage T1b to T3, Nx, N0 and N1, M0 were included in a prospective multicenter observational study with a fully sequential design, using a stopping rule. All patients received remnant ablation with 131I using rhTSH. Ablation success was defined as no visible uptake in the original thyroid bed on a rhTSH stimulated 150 MBq 131I whole body scan (WBS) 9 months after remnant ablation, or no visible uptake in the original thyroid bed on a post therapeutic WBS when a second high dose was necessary. After interim analysis of the first 8 patients, the failure rate was estimated to be 69% (90% confidence interval (CI) 20-86%) and the inclusion of new patients had to be stopped. Final analysis resulted in an ablation success in 11 out of 17 patients (65%, 95% CI 38-86%). According to this study, the efficacy of rhTSH in the preparation of 131I ablation therapy is inferior, when using a strict definition of ablation success. The current lack of agreement as to the definition of successful remnant ablation, makes comparison between different ablation strategies difficult. Our results point to the need for an international consensus on the definition of ablation success, not only in routine patient's care but also for scientific reasons. Dutch Trial Registration NTR2395.