Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study

Søren Fast, Laszlo Hegedus, Furio Pacini, Aldo Pinchera, Angela M Leung, Mário Vaisman, Christoph Reiners, Jean-Louis Wemeau, Dyde Huysmans, William Harper, Irina Rachinsky, Hevelyn Noemberg De Souza, Maria Grazia Castagna, Lucia Antonangeli, Lewis E Braverman, Rossana Corbo, Christian Düren, Emmanuelle Proust-Lemoine, Chris Marriott, Al DriedgerPeter Grupe, Torquil Watt, James Magner, Annie Purvis, Hans Graf

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Background: Enhanced reduction of multinodular goiter (MNG) can be achieved by stimulation with recombinant human thyrotropin (rhTSH) before radioiodine (131I) therapy. The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH (MRrhTSH) in combination with 131I-therapy. Methods: In this phase II, single-blinded, placebo-controlled study, 95 patients (57.2±9.6 years old, 85% women, 83% Caucasians) with MNG (median size 96.0 ml (31.9 - 242.2 ml)) were randomized to receive placebo (n=32), 0.01 mg MRrhTSH (n=30) or 0.03 mg MRrhTSH (n=33), 24 hours before a calculated 131I activity. Thyroid volume (TV) and smallest cross-sectional area of trachea (SCAT) were measured (by CT-scan) at baseline, month 6 and month 36. Thyroid function and quality of life (QoL) was evaluated at 3 month and yearly intervals, respectively. Results: At 6 months, TV reduction was enhanced in the 0.03 mg MRrhTSH group (32.9% versus 23.1% in the placebo group, p=0.03), but not in the 0.01 mg MRrhTSH group. At month 36 the mean percent TV reduction from baseline was 44 ± 12.7% (SD) in the placebo group, 41 ± 21.0% in the 0.01 mg MRrhTSH-group and 53 ± 18.6% in the 0.03 mg MRrhTSH-group, with no statistically significant differences among the groups, p=0.105. In the 0.03 mg MRrhTSH-group, the subset of patients with basal 131I uptake
OriginalsprogEngelsk
TidsskriftThyroid
Vol/bind24
Udgave nummer4
Sider (fra-til)727-735
ISSN1050-7256
DOI
StatusUdgivet - 2014

Fingeraftryk

Placebos
Quality of Life
Safety

Citer dette

Fast, Søren ; Hegedus, Laszlo ; Pacini, Furio ; Pinchera, Aldo ; Leung, Angela M ; Vaisman, Mário ; Reiners, Christoph ; Wemeau, Jean-Louis ; Huysmans, Dyde ; Harper, William ; Rachinsky, Irina ; De Souza, Hevelyn Noemberg ; Castagna, Maria Grazia ; Antonangeli, Lucia ; Braverman, Lewis E ; Corbo, Rossana ; Düren, Christian ; Proust-Lemoine, Emmanuelle ; Marriott, Chris ; Driedger, Al ; Grupe, Peter ; Watt, Torquil ; Magner, James ; Purvis, Annie ; Graf, Hans. / Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study. I: Thyroid. 2014 ; Bind 24, Nr. 4. s. 727-735.
@article{52a66427b2cd4298be19196381a3806b,
title = "Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study",
abstract = "Background: Enhanced reduction of multinodular goiter (MNG) can be achieved by stimulation with recombinant human thyrotropin (rhTSH) before radioiodine (131I) therapy. The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH (MRrhTSH) in combination with 131I-therapy. Methods: In this phase II, single-blinded, placebo-controlled study, 95 patients (57.2±9.6 years old, 85{\%} women, 83{\%} Caucasians) with MNG (median size 96.0 ml (31.9 - 242.2 ml)) were randomized to receive placebo (n=32), 0.01 mg MRrhTSH (n=30) or 0.03 mg MRrhTSH (n=33), 24 hours before a calculated 131I activity. Thyroid volume (TV) and smallest cross-sectional area of trachea (SCAT) were measured (by CT-scan) at baseline, month 6 and month 36. Thyroid function and quality of life (QoL) was evaluated at 3 month and yearly intervals, respectively. Results: At 6 months, TV reduction was enhanced in the 0.03 mg MRrhTSH group (32.9{\%} versus 23.1{\%} in the placebo group, p=0.03), but not in the 0.01 mg MRrhTSH group. At month 36 the mean percent TV reduction from baseline was 44 ± 12.7{\%} (SD) in the placebo group, 41 ± 21.0{\%} in the 0.01 mg MRrhTSH-group and 53 ± 18.6{\%} in the 0.03 mg MRrhTSH-group, with no statistically significant differences among the groups, p=0.105. In the 0.03 mg MRrhTSH-group, the subset of patients with basal 131I uptake",
author = "S{\o}ren Fast and Laszlo Hegedus and Furio Pacini and Aldo Pinchera and Leung, {Angela M} and M{\'a}rio Vaisman and Christoph Reiners and Jean-Louis Wemeau and Dyde Huysmans and William Harper and Irina Rachinsky and {De Souza}, {Hevelyn Noemberg} and Castagna, {Maria Grazia} and Lucia Antonangeli and Braverman, {Lewis E} and Rossana Corbo and Christian D{\"u}ren and Emmanuelle Proust-Lemoine and Chris Marriott and Al Driedger and Peter Grupe and Torquil Watt and James Magner and Annie Purvis and Hans Graf",
year = "2014",
doi = "10.1089/thy.2013.0370",
language = "English",
volume = "24",
pages = "727--735",
journal = "Thyroid",
issn = "1050-7256",
publisher = "Mary Ann Liebert Incorporated",
number = "4",

}

Fast, S, Hegedus, L, Pacini, F, Pinchera, A, Leung, AM, Vaisman, M, Reiners, C, Wemeau, J-L, Huysmans, D, Harper, W, Rachinsky, I, De Souza, HN, Castagna, MG, Antonangeli, L, Braverman, LE, Corbo, R, Düren, C, Proust-Lemoine, E, Marriott, C, Driedger, A, Grupe, P, Watt, T, Magner, J, Purvis, A & Graf, H 2014, 'Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study', Thyroid, bind 24, nr. 4, s. 727-735. https://doi.org/10.1089/thy.2013.0370

Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study. / Fast, Søren; Hegedus, Laszlo; Pacini, Furio; Pinchera, Aldo; Leung, Angela M; Vaisman, Mário; Reiners, Christoph; Wemeau, Jean-Louis; Huysmans, Dyde; Harper, William; Rachinsky, Irina; De Souza, Hevelyn Noemberg; Castagna, Maria Grazia; Antonangeli, Lucia; Braverman, Lewis E; Corbo, Rossana; Düren, Christian; Proust-Lemoine, Emmanuelle; Marriott, Chris; Driedger, Al; Grupe, Peter; Watt, Torquil; Magner, James; Purvis, Annie; Graf, Hans.

I: Thyroid, Bind 24, Nr. 4, 2014, s. 727-735.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Long-term efficacy of modified-release recombinant human TSH (MRrhTSH) augmented radioiodine (131I) therapy for benign multinodular goiter. Results from a multicenter international, randomized, placebo-controlled dose-selection study

AU - Fast, Søren

AU - Hegedus, Laszlo

AU - Pacini, Furio

AU - Pinchera, Aldo

AU - Leung, Angela M

AU - Vaisman, Mário

AU - Reiners, Christoph

AU - Wemeau, Jean-Louis

AU - Huysmans, Dyde

AU - Harper, William

AU - Rachinsky, Irina

AU - De Souza, Hevelyn Noemberg

AU - Castagna, Maria Grazia

AU - Antonangeli, Lucia

AU - Braverman, Lewis E

AU - Corbo, Rossana

AU - Düren, Christian

AU - Proust-Lemoine, Emmanuelle

AU - Marriott, Chris

AU - Driedger, Al

AU - Grupe, Peter

AU - Watt, Torquil

AU - Magner, James

AU - Purvis, Annie

AU - Graf, Hans

PY - 2014

Y1 - 2014

N2 - Background: Enhanced reduction of multinodular goiter (MNG) can be achieved by stimulation with recombinant human thyrotropin (rhTSH) before radioiodine (131I) therapy. The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH (MRrhTSH) in combination with 131I-therapy. Methods: In this phase II, single-blinded, placebo-controlled study, 95 patients (57.2±9.6 years old, 85% women, 83% Caucasians) with MNG (median size 96.0 ml (31.9 - 242.2 ml)) were randomized to receive placebo (n=32), 0.01 mg MRrhTSH (n=30) or 0.03 mg MRrhTSH (n=33), 24 hours before a calculated 131I activity. Thyroid volume (TV) and smallest cross-sectional area of trachea (SCAT) were measured (by CT-scan) at baseline, month 6 and month 36. Thyroid function and quality of life (QoL) was evaluated at 3 month and yearly intervals, respectively. Results: At 6 months, TV reduction was enhanced in the 0.03 mg MRrhTSH group (32.9% versus 23.1% in the placebo group, p=0.03), but not in the 0.01 mg MRrhTSH group. At month 36 the mean percent TV reduction from baseline was 44 ± 12.7% (SD) in the placebo group, 41 ± 21.0% in the 0.01 mg MRrhTSH-group and 53 ± 18.6% in the 0.03 mg MRrhTSH-group, with no statistically significant differences among the groups, p=0.105. In the 0.03 mg MRrhTSH-group, the subset of patients with basal 131I uptake

AB - Background: Enhanced reduction of multinodular goiter (MNG) can be achieved by stimulation with recombinant human thyrotropin (rhTSH) before radioiodine (131I) therapy. The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH (MRrhTSH) in combination with 131I-therapy. Methods: In this phase II, single-blinded, placebo-controlled study, 95 patients (57.2±9.6 years old, 85% women, 83% Caucasians) with MNG (median size 96.0 ml (31.9 - 242.2 ml)) were randomized to receive placebo (n=32), 0.01 mg MRrhTSH (n=30) or 0.03 mg MRrhTSH (n=33), 24 hours before a calculated 131I activity. Thyroid volume (TV) and smallest cross-sectional area of trachea (SCAT) were measured (by CT-scan) at baseline, month 6 and month 36. Thyroid function and quality of life (QoL) was evaluated at 3 month and yearly intervals, respectively. Results: At 6 months, TV reduction was enhanced in the 0.03 mg MRrhTSH group (32.9% versus 23.1% in the placebo group, p=0.03), but not in the 0.01 mg MRrhTSH group. At month 36 the mean percent TV reduction from baseline was 44 ± 12.7% (SD) in the placebo group, 41 ± 21.0% in the 0.01 mg MRrhTSH-group and 53 ± 18.6% in the 0.03 mg MRrhTSH-group, with no statistically significant differences among the groups, p=0.105. In the 0.03 mg MRrhTSH-group, the subset of patients with basal 131I uptake

U2 - 10.1089/thy.2013.0370

DO - 10.1089/thy.2013.0370

M3 - Journal article

C2 - 24341527

VL - 24

SP - 727

EP - 735

JO - Thyroid

JF - Thyroid

SN - 1050-7256

IS - 4

ER -