title: Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard(®)/Depo-Eligard(®)) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study.
abstract: BACKGROUND
  The 1-, 3- and 6- month biodegradable polymer matrix depot formulations of leuprorelin acetate (Eligard(®)/Depo-Eligard(®), Astellas Pharma Inc/BV) were shown to reduce testosterone and prostate-specific antigen levels and to be well tolerated in patients with advanced prostate cancer in several clinical trials. This study aimed at evaluating the efficacy, safety and tolerability of the 1- and 3-month leuprorelin acetate depot formulations in daily clinical practice.
  
  
  METHODS
  A prospective, open-label, non-interventional, phase IV study (MANTA) was conducted in 243 Belgian prostate cancer patients who had been prescribed the 1-month (7.5 mg) or 3-month (22.5 mg) leuprorelin acetate depot formulation. Patients were followed for at least 3 months.
  
  
  RESULTS
  Median serum prostate-specific antigen levels were reduced by 95% from 12.0 ng/ml at baseline to 0.60 ng/ml after a median follow-up time of 132 days, while median testosterone levels were reduced by 94% from 360 ng/dl to 20 ng/dl. Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86%) experienced treatment-emergent adverse events, with injection site-related reactions, hot flushes and tumor flare being the most common ones. Overall safety and tolerability of the leuprorelin acetate depot formulation were rated as good or excellent by 90% of physicians.
  
  
  CONCLUSIONS
  These data are consistent with efficacy and tolerability results from clinical trials. They confirm that the 1- and 3-month leuprorelin acetate depot formulations are well tolerated and reliably lower serum prostate-specific antigen and testosterone levels in routine clinical practice.
authors.affiliation: Department of Urology, University Hospital of Brussels, Brussels, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Braeckman
authors.affiliation: Department of Urology, University Hospital of Brussels, Brussels, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Michielsen
keywords: leuprolide; physician's practice patterns; prospective studies; prostatic neoplasms; treatment outcome
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