title: Bicalutamide plus anastrozole for the treatment of gonadotropin-independent precocious puberty in boys with testotoxicosis: a phase II, open-label pilot study (BATT).
abstract: OBJECTIVE
  To evaluate the efficacy, tolerability, and pharmacokinetics of bicalutamide plus anastrozole in young males with testotoxicosis.
  
  
  METHODS
  This was a multicenter, open-label, single-arm, 12-month, Phase II pilot trial in 14 males (2-9 years) with testotoxicosis treated with bicalutamide (12.5, 25, 50, or 100 mg) and anastrozole (0.5 or 1 mg) daily. The primary outcome was change in growth rate.
  
  
  RESULTS
  At 1 year, the mean (standard deviation) change from baseline in growth rate was -1.6 (+/- 5.1) cm/year and -0.1 (+/- 1.8) SD units, and in bone maturation was -2.3 (+/- 0.5) years. The bone age/chronological age ratio was reduced from 2.1 (+/- 0.6) at baseline to 1.0 (+/- 0.4) (p = 0.00013). Steady-state trough R-bicalutamide and anastrozole concentrations were attained by Day 21 and 8, respectively. Gynecomastia (42.9%) and breast tenderness (12.5%) were the most common treatment-related adverse events.
  
  
  CONCLUSIONS
  Treatment of testotoxicosis with bicalutamide plus anastrozole resulted in slower growth rate.
authors.affiliation: Baystate Children's Hospital, Tufts University School of Medicine, Springfield, MA, USA. edward.reiter@bhs.org
authors.forename: Edward O
authors.initials: EO
authors.lastname: Reiter
authors.forename: Nelly
authors.initials: N
authors.lastname: Mauras
authors.forename: Ken
authors.initials: K
authors.lastname: McCormick
authors.forename: Bindu
authors.initials: B
authors.lastname: Kulshreshtha
authors.forename: James
authors.initials: J
authors.lastname: Amrhein
authors.forename: Francesco
authors.initials: F
authors.lastname: De Luca
authors.forename: Sandra
authors.initials: S
authors.lastname: O'Brien
authors.forename: Jon
authors.initials: J
authors.lastname: Armstrong
authors.forename: Helena
authors.initials: H
authors.lastname: Melezinkova
mesh_terms: D000077384:Anastrozole; D000813:Anilides / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001846:Bone Development / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D006062:Gonadotropins / Q000097:blood*; D006128:Growth / Q000187:drug effects; D006801:Humans; D008297:Male; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D010865:Pilot Projects; D011629:Puberty, Precocious / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D014105:Tosyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D000813:Anilides; D006062:Gonadotropins; D009570:Nitriles; D014105:Tosyl Compounds; D014230:Triazoles; D000077384:Anastrozole; C053541:bicalutamide