title: A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission.
abstract: BACKGROUND
  The current study was conducted to determine the effect of goserelin and bicalutamide on progression-free survival (PFS) in patients with epithelial ovarian cancer who were in second or greater complete disease remission.
  
  
  METHODS
  Patients received bicalutamide at a dose of 50 mg orally daily and goserelin at a dose of 3.6 mg subcutaneously every 4 weeks. CA 125 was obtained monthly, with computed tomography performed every 3 months. Correlative studies included serum luteinizing hormone, follicle-stimulating hormone, vascular endothelial growth factor, free testosterone, and androstenedione and the germline polymorphisms CYP19A1 and androgen receptor.
  
  
  RESULTS
  Between October of 2000 and October of 2002, 35 patients were enrolled. Three patients (9%) received therapy at the time of first disease remission and were removed from the study, and 1 patient (3%) was removed for liver function test abnormalities. The most frequent toxicities were grade 1 alkaline phosphatase (54%), fatigue (57%), and hot flashes (42%) based on the National Cancer Institute common toxicity scale, version 2.0. The PFS for patients receiving protocol therapy in second disease remission (21 patients) was 11.4 months (95% confidence interval [95% CI], 10.2-12.6 months). The PFS for patients receiving protocol therapy in third or fourth disease remission (11 patients) was 11.9 months (95% CI, 10.8-14.1 months). The percentage of patients remaining in second disease remission at given times are: 100% at 3 months, 100% at 6 months, 72% at 9 months, 47% at 12 months, 28% at 15 months, 22% at 18 months, 19% at 21 months, and 13% at 24 months. There were no associations noted between androgen receptor repeat number, genotype, allelotype, or haplotypes and PFS.
  
  
  CONCLUSIONS
  The use of goserelin and bicalutamide did not appear to prolong PFS in patients with epithelial ovarian cancer in second or greater complete disease remission. The number of patients in disease remission at given time points may serve as a clinical trial endpoint for future studies of consolidation therapy.
authors.affiliation: Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Levine
authors.forename: Kay
authors.initials: K
authors.lastname: Park
authors.forename: Margrit
authors.initials: M
authors.lastname: Juretzka
authors.forename: Julie
authors.initials: J
authors.lastname: Esch
authors.forename: Martee
authors.initials: M
authors.lastname: Hensley
authors.forename: Carol
authors.initials: C
authors.lastname: Aghajanian
authors.forename: Sharyn
authors.initials: S
authors.lastname: Lewin
authors.forename: Jason
authors.initials: J
authors.lastname: Konner
authors.forename: Felicia
authors.initials: F
authors.lastname: Derosa
authors.forename: David
authors.initials: D
authors.lastname: Spriggs
authors.forename: Alexia
authors.initials: A
authors.lastname: Iasonos
authors.forename: Paul
authors.initials: P
authors.lastname: Sabbatini
mesh_terms: D000328:Adult; D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage; D000813:Anilides / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009570:Nitriles / Q000008:administration & dosage*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D014105:Tosyl Compounds / Q000008:administration & dosage*
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; C053541:bicalutamide