title: Phase I clinical trials in 56 patients with thyroid cancer: the M. D. Anderson Cancer Center experience.
abstract: BACKGROUND
  Thyroid cancer is the most common endocrine malignancy. The outcomes of patients with relapsed thyroid cancer treated on early-phase clinical trials have not been systematically analyzed.
  
  
  METHODS
  We reviewed the records of consecutive patients with metastatic thyroid cancer referred to the Phase I Clinical Trials Program from March 2006 to April 2008. Best response was assessed by Response Evaluation Criteria in Solid Tumors.
  
  
  RESULTS
  Fifty-six patients were identified. The median age was 55 yr (range 35-79 yr). Of 49 patients evaluable for response, nine (18.4%) had a partial response, and 16 (32.7%) had stable disease for 6 months or longer. The median progression-free survival was 1.12 yr. With a median follow-up of 15.6 months, the 1-yr survival rate was 81%. In univariate analysis, factors predicting shorter survival were anaplastic histology (P = 0.0002) and albumin levels less than 3.5 g/dl (P = 0.05). Among 26 patients with tumor decreases, none died (median follow-up 1.3 yr), whereas 52% of patients with any tumor increase died by 1 yr (P = 0.0001). The median time to failure in our phase I clinical trials was 11.5 months vs. 4.1 months for the previous treatment (P = 0.04).
  
  
  CONCLUSIONS
  Patients with advanced thyroid cancer treated on phase I clinical trials had high rates of partial response and prolonged stable disease. Time to failure was significantly longer on the first phase I trial compared with the prior conventional treatment. Patients with any tumor decrease had significantly longer survival than those with any tumor increase.
authors.affiliation: Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030, USA. atsimber@mdanderson.org
authors.forename: Apostolia Maria
authors.initials: AM
authors.lastname: Tsimberidou
authors.forename: Christos
authors.initials: C
authors.lastname: Vaklavas
authors.forename: Sijin
authors.initials: S
authors.lastname: Wen
authors.forename: David
authors.initials: D
authors.lastname: Hong
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wheler
authors.forename: Chaan
authors.initials: C
authors.lastname: Ng
authors.forename: Aung
authors.initials: A
authors.lastname: Naing
authors.forename: Susan
authors.initials: S
authors.lastname: Tse
authors.forename: Naifa
authors.initials: N
authors.lastname: Busaidy
authors.forename: Maurie
authors.initials: M
authors.lastname: Markman
authors.forename: Steven I
authors.initials: SI
authors.lastname: Sherman
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D003404:Creatinine / Q000097:blood; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015996:Survival Rate; D017741:Survivors; D013964:Thyroid Neoplasms / Q000401:mortality / Q000628:therapy*
chemical_list: D003404:Creatinine