title: Endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of goserelin acetate administered every 13 weeks to patients with advanced prostate cancer.
abstract: OBJECTIVE
  To determine the endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of Zoladextrade mark (goserelin acetate, Zeneca Pharmaceuticals, Wilmington, Delaware, USA), a luteinizing hormone-releasing hormone agonist analogue, when administration was extended from every 12 weeks to every 13 weeks in patients with advanced prostate cancer.
  
  
  METHODS
  Between July 1995 and May 1996, 59 patients with either locally advanced (T3 or T4) or metastatic prostate cancer were enrolled in an open-label, multicentre trial. Primary efficacy endpoints were testosterone measurements, and assessments of prostate specific antigen (PSA) response, subjective and objective response. Quality of life (QoL) was a secondary efficacy endpoint.
  
  
  RESULTS
  Mean testosterone concentrations decreased to < 0.3 microgram/L by week 4 and remained so for the duration of treatment. There were no statistically significant differences in mean testosterone levels between weeks 12 and 13, or weeks 25 and 26. Serum testosterone suppression was adequate in all 58 evaluable patients at week 13, and 51 of 52 (98%) patients at week 26. Of the 58 evaluable patients, 52 (90%) had a PSA response. A subjective response was recorded for six of 11 evaluable patients. Of 58 patients evaluable for objective response, 46 (79%) had a partial response, three (5%) had stable disease and nine (16%) had objective progression. Except for a significant (P=0.014) decrease in overall sexual interest, QoL was unchanged during therapy. The most common side-effects, regardless of causality, were hot flushes (67%), pain (31%) and pelvic pain (22%). Mild injection-site complaints occurred with only three of 221 (1.4%) depot injections.
  
  
  CONCLUSIONS
  Zoladextrade mark 10.8-mg depot, administered every 13 weeks to patients with advanced prostatic cancer, is well tolerated, provides adequate suppression of serum testosterone and produces PSA, subjective and objective responses.
authors.affiliation: University of Texas Health Science Center, San Antonio, Texas, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Sarosdy
authors.forename: P F
authors.initials: PF
authors.lastname: Schellhammer
authors.forename: M S
authors.initials: MS
authors.lastname: Soloway
authors.forename: N J
authors.initials: NJ
authors.lastname: Vogelzang
authors.forename: E D
authors.initials: ED
authors.lastname: Crawford
authors.forename: J
authors.initials: J
authors.lastname: Presti
authors.forename: G W
authors.initials: GW
authors.lastname: Chodak
authors.forename: P
authors.initials: P
authors.lastname: Mitchell
authors.forename: L
authors.initials: L
authors.lastname: Porter
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D011788:Quality of Life; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D017273:Goserelin; D013739:Testosterone; D017430:Prostate-Specific Antigen