title: Two innovative pharmaceutical forms of leuprorelin: results from 818 patients with advanced prostate cancer.
abstract: OBJECTIVE
  This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice.
  
  
  METHODS
  Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with slow-release luteinizing hormone-releasing hormone (LHRH) agonist formulations and who were about to be switched to the leuprorelin implants. Patients received three injections of 1- or 3-month leuprorelin implant and physicians were asked to complete a case report form specific to each of the three clinic visits. Documented parameters included laboratory measurements, such as testosterone and prostate-specific antigen (PSA) levels, adverse events, and patient- and physician-rated assessments of the therapy.
  
  
  RESULTS
  Compared with baseline, a significant decrease in both testosterone and PSA levels were measured after the first and second injections of leuprorelin implant. These results were confirmed for both the 1-month and 3-month implants in separate analyses. Switching, without treatment interruption, from Trenantone® (Takeda Pharma GmBH, Aachen, Germany) to the leuprorelin implant resulted in a significant decrease in the mean serum testosterone concentrations (P < 0.05) and a nonsignificant increase in the proportion of patients reaching castrate testosterone levels, while the number of patients with PSA values ≤ 4 ng/mL significantly increased (P = 0.045). Similar results were obtained for patients previously treated with goserelin who switched to leuprorelin implant. For 94% of patients, treating physicians rated the efficacy of leuprorelin implant as "very good" or "good." Treatment with leuprorelin implant was well tolerated, with only 61 adverse events reported in 42 (5.1%) patients. Patients and physicians rated the tolerability of leuprorelin implant as "very good" or "good" in 95% and 91% of cases, respectively.
  
  
  CONCLUSIONS
  These results confirm the efficacy, tolerability, and ease of use of the leuprorelin implants among a large population of men with advanced, hormone-dependent prostate cancer treated in a clinical practice setting.
authors: Triskel Integrated Services, 4 rue des Terreaux-du-Temple, 1201 Geneva, Switzerland. pgravel@triskel.com
authors: Patricia
authors: P
authors: Gravel
authors: Dirk
authors: D
authors: Samland
authors: Martin
authors: M
authors: Löffler
authors: Simone
authors: S
authors: Maier
authors: Micol
authors: M
authors: Panozzo
authors: Michael
authors: M
authors: Muenzberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D004343:Drug Implants / Q000627:therapeutic use; D006801:Humans; D007610:Kallikreins / Q000097:blood; D016729:Leuprolide / Q000627:therapeutic use*; D008297:Male; D009376:Neoplasms, Hormone-Dependent; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004343:Drug Implants; D013739:Testosterone; C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen; D016729:Leuprolide