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J Clin Endocrinol Metab. 2018 Nov 5. doi: 10.1210/jc.2018-01589. [Epub ahead of print]

Recombinant thyrotropin vs levothyroxine withdrawal in 131I therapy of N1 thyroid cancer: a large matched cohort study (ThyrNod).

Author information

1
Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France.
2
Gustave Roussy, Univ. Paris Saclay Villejuif, France.
3
Hospices Civils de Lyon, Lyon, France.
4
Institute University du cancer Toulouse, France.
5
Jean Godinot Centre, Reims, France.
6
François Baclesse Centre, Caen, France.
7
Jean Perrin Centre, Clermont-Ferrand, France.
8
Paul Papin Centre, Angers, France.
9
Georges François Leclerc Centre, Dijon, France.
10
René Gauducheau Centre, Nantes, France.
11
Saint-Louis Hospital, Paris, France.
12
CHRU de Lille, Lille, France.
13
Montpellier Cancer Institute, Montpellier, France.
14
St André Hospital, Bordeaux, France.
15
Sanofi Genzyme, France.
16
Aix-Marseille Univ, La Timone University Hospital, CERIMED, France.

Abstract

Context:

Recombinant human thyrotropin (rhTSH) has been shown to be an effective stimulation method for radioactive iodine (RAI) therapy in differentiated thyroid cancer including those with nodal metastases (N1 DTC).

Objectives:

To demonstrate the non-inferiority of rhTSH vs thyroid hormone withdrawal (THW) in preparation to RAI regarding disease status at the first evaluation in the real-life setting in N1 DTC patients.

Design, patients:

This was a French multicenter retrospective study. Groups were matched according to age (<45/≥45 years), number of N1 (≤5/>5 lymph nodes) and stage (pT1-T2/pT3).

Results:

The cohort consisted of 404 pT1-T3/N1/M0 DTC, prepared with rhTSH (n=205) or THW (n=199). Pathological characteristics and initial administrated RAI activities (3.27 ±1.00 GBq) were similar between the two groups. At first evaluation (6-18 months post-RAI), disease-free status was defined by thyroglobulin levels below threshold and a normal ultrasound. Disease-free rate was not inferior in the rhTSH group (75.1%) compared to the THW group (71.9%). The observed difference between the success rates was 3.3 % [-6.6; 13.0]; rhTSH was therefore considered non-inferior to THW as the upper limit of this interval was less than 15%. At the last evaluation (29.7± 20.7 for rhTSH and 36.7± 23.8 months for THW)), 83.5% (rhTSH) and 81.5% (THW) of patients achieved a complete response. This result was not influenced by any of the known prognostic factors.

Conclusions:

A preparation for initial RAI treatment with rhTSH was non-inferior to one with THW in our series of pT1-T3/N1/M0-DTC on disease-free status outcomes at the first evaluation and after three years.

PMID:
30398518
DOI:
10.1210/jc.2018-01589

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