title: Quality of life changes and clinical outcomes in thyroid cancer patients undergoing radioiodine remnant ablation (RRA) with recombinant human TSH (rhTSH): a randomized controlled study.
abstract: BACKGROUND
  Recombinant human TSH (rhTSH) has become the modality of choice for radioiodine remnant ablation (RRA) in low-risk thyroid cancer patients.
  
  
  OBJECTIVE
  The aims of the present prospective randomized study were to evaluate the impact of TSH stimulation procedure (hypothyroidism vs. rhTSH) on quality of life (QoL) of thyroid cancer patients undergoing RRA and to evaluate efficacy of both procedures. L-T4 was initiated in both groups after thyroidectomy. After randomization, L-T4 was discontinued in hypothyroid (hypo) group and continued in rhTSH group. A measure of 3.7 GBq of radioiodine was given to both groups. The functional assessment of chronic illness therapy-fatigue (FACIT-F) was administered from the early postoperative period to 9 months. Socio-demographic parameters, anxiety and depression scales were also evaluated (CES-D, BDI and Spielberger state-trait questionnaires). At 9 months, patients underwent an rhTSH stimulation test, diagnostic (131)I whole body scan (dxWBS) and neck ultrasonography.
  
  
  RESULTS
  A total of 74 patients were enrolled for the study. There was a significant decrease in QoL from baseline (t0) to t1 (RRA period) in the hypothyroid group with significant differences in FACIT-F TOI (P < 10(-3)), FACT-G total score (P = 0.005) and FACIT-F total score (P = 0.003). By contrast, QoL was preserved in the rhTSH group. In the multivariate analysis, FACIT-TOI changes were only affected by the modality of TSH stimulation performed for RRA. From 3 to 9 months, changes of QoL scales and subscales were no longer statistically different in both groups of patients. Based on serum rhTSH-stimulated Tg alone (Tg < 0.8 microg/l, BRAHMS Tg Kryptor), no difference in ablation success was observed between rhTSH and hypothyroidism groups, 91.7% and 97.1%, respectively. A higher rate of persistent thyroid remnants was observed in the rhTSH arm, although in most cases uptake was < 0.1% and of no clinical significance.
  
  
  CONCLUSIONS
  rhTSH preserves QoL of patients undergoing RRA with similar rates of ablation success compared to hypothyrodism. However, there is a wide heterogeneity in the clinical impact of hypothyroidism.
authors.affiliation: Service Central de Biophysique et de Médecine Nucléaire, Centre Hospitalo-Universitaire de la Timone, Marseille Cedex 5, France. david.taieb@ap-hm.fr
authors.forename: D
authors.initials: D
authors.lastname: Taïeb
authors.forename: F
authors.initials: F
authors.lastname: Sebag
authors.forename: M
authors.initials: M
authors.lastname: Cherenko
authors.forename: K
authors.initials: K
authors.lastname: Baumstarck-Barrau
authors.forename: C
authors.initials: C
authors.lastname: Fortanier
authors.forename: B
authors.initials: B
authors.lastname: Farman-Ara
authors.forename: C
authors.initials: C
authors.lastname: De Micco
authors.forename: J
authors.initials: J
authors.lastname: Vaillant
authors.forename: S
authors.initials: S
authors.lastname: Thomas
authors.forename: B
authors.initials: B
authors.lastname: Conte-Devolx
authors.forename: A
authors.initials: A
authors.lastname: Loundou
authors.forename: P
authors.initials: P
authors.lastname: Auquier
authors.forename: J F
authors.initials: JF
authors.lastname: Henry
authors.forename: O
authors.initials: O
authors.lastname: Mundler
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D013964:Thyroid Neoplasms / Q000188:drug therapy*; D013972:Thyrotropin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes; D011994:Recombinant Proteins; D013972:Thyrotropin