title: Analysis of the efficacy and toxicity of sorafenib in thyroid cancer: a phase II study in a UK based population.
abstract: OBJECTIVE
  To evaluate the tolerability and efficacy of sorafenib in patients with thyroid carcinoma.
  
  
  METHODS
  Patients with progressive locally advanced/metastatic medullary thyroid carcinoma (MTC), or differentiated thyroid carcinoma (DTC) with non-radioiodine-avid disease, were treated with sorafenib 400 mg twice daily until disease progression. The primary endpoint was the radiological response rate (RR) at 6 months. Secondary endpoints were RR at 3, 9 and 12 months, biochemical responses, toxicity, biomarker analyses and progression free and overall survival (OS).
  
  
  RESULTS
  A total of 34 patients were recruited to the study (15 medullary and 19 differentiated). After 6 months, the RR rate was 15% and a further 74% of patients achieved stable disease in the first 6 months. After 12 months of treatment, the RR was 21%. In the MTC patients, the RR at 12 months was 25% and OS was 100%. In DTC patients corresponding rates were 18 and 79% respectively. Median overall and progression-free survival points were not reached at 19 months. Commonest adverse events included hand-foot syndrome, other skin toxicities, diarrhoea and alopecia. Dose reduction was required in 79% patients. Median time on treatment was 16.5 months.
  
  
  CONCLUSIONS
  This study demonstrates that sorafenib is tolerable at reduced doses over prolonged periods of time in patients with thyroid cancer. Sorafenib leads to radiological and biochemical stabilisation of disease in the majority of these patients despite dose reductions.
authors.affiliation: Head and Neck Unit, The Royal Marsden NHS Foundation Trust, Fulham Road, London SW3 6JJ, UK. merina.ahmed@rmh.nhs.uk
authors.forename: Merina
authors.initials: M
authors.lastname: Ahmed
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Barbachano
authors.forename: Angela
authors.initials: A
authors.lastname: Riddell
authors.forename: Jen
authors.initials: J
authors.lastname: Hickey
authors.forename: Katie L
authors.initials: KL
authors.lastname: Newbold
authors.forename: Amaya
authors.initials: A
authors.lastname: Viros
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Harrington
authors.forename: Richard
authors.initials: R
authors.lastname: Marais
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Nutting
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001557:Benzenesulfonates / Q000009:adverse effects* / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011153:Population; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use*; D000077157:Sorafenib; D016019:Survival Analysis; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib