title: Could thyroid dysfunction influence outcome in sunitinib-treated metastatic renal cell carcinoma?
abstract: BACKGROUND
  Sunitinib is a standard of care for metastatic renal cell carcinoma (mRCC). Hypothyroidism is frequently observed under sunitinib therapy. This study was conducted to prospectively determine the correlation between thyroid function and progression-free survival (PFS) in this population.
  
  
  METHODS
  One hundred and eleven mRCC patients treated with sunitinib were evaluated for serum thyroid-stimulating hormone (TSH) and T4 levels before treatment and every 6 weeks during treatment. Survival was analysed according to a landmark method with a cut-off of 6 months, excluding early progressive or early-censored patients.
  
  
  RESULTS
  Out of the 102 patients with normal baseline thyroid function, 53% developed thyroid dysfunction, including 95% hypothyroidisms out of which 90.9% received L-thyroxine replacement. Median time to TSH alteration was 5.4 months. Median PFS was 11.7 months for the entire population. Median PFS was not different between the groups with abnormal or normal thyroid function after 6 months of treatment (18.9 and 15.9 months, respectively, log-rank P = 0.94, hazard ratio = 1.02, 95% confidence interval = 0.54-1.93). There was no difference even after adjustment for Memorial Sloan-Kettering Cancer Centre classification and therapy line.
  
  
  CONCLUSIONS
  Abnormal thyroid function with hormonal substitution did not increase survival in our population, independent of initial prognosis and previous treatments. Larger comparative studies are deserved to validate these conclusions.
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Centre de Recherche contre le Cancer, INSERM UMR 891, Marseille. Electronic address: sabatierr@marseille.fnclcc.fr.
authors.forename: R
authors.initials: R
authors.lastname: Sabatier
authors.affiliation: Department of Surgery, Institut Paoli-Calmettes, Marseille.
authors.forename: J C
authors.initials: JC
authors.lastname: Eymard
authors.affiliation: Department of Medical Oncology, Institut Jean Godinot, Reims.
authors.forename: J
authors.initials: J
authors.lastname: Walz
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors.forename: J L
authors.initials: JL
authors.lastname: Deville
authors.affiliation: Department of Endocrinology, CHU Marseille, Hôpital de la Timone, Marseille.
authors.forename: H
authors.initials: H
authors.lastname: Narbonne
authors.affiliation: Departments of Biostatistics.
authors.forename: J M
authors.initials: JM
authors.lastname: Boher
authors.affiliation: Departments of Radiotherapy Oncology.
authors.forename: N
authors.initials: N
authors.lastname: Salem
authors.affiliation: Departments of Anatomo-Pathology.
authors.forename: M
authors.initials: M
authors.lastname: Marcy
authors.affiliation: Departments of Radiology, Institut Paoli-Calmettes, Marseille.
authors.forename: S
authors.initials: S
authors.lastname: Brunelle
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Centre de Recherche contre le Cancer, INSERM UMR 891, Marseille; Université de la Méditerranée, UFR Médecine, Marseille.
authors.forename: P
authors.initials: P
authors.lastname: Viens
authors.affiliation: Université de la Méditerranée, UFR Médecine, Marseille; Department of Urology, CHU Marseille, Hôpital Sainte Marguerite, Marseille, France.
authors.forename: F
authors.initials: F
authors.lastname: Bladou
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Centre de Recherche contre le Cancer, INSERM UMR 891, Marseille.
authors.forename: G
authors.initials: G
authors.lastname: Gravis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000401:mortality*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007037:Hypothyroidism / Q000139:chemically induced* / Q000453:epidemiology*; D015994:Incidence; D007211:Indoles / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011758:Pyrroles / Q000009:adverse effects; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib