A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission.
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.
Levine
Douglas
D
Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Park
Kay
K
Juretzka
Margrit
M
Esch
Julie
J
Hensley
Martee
M
Aghajanian
Carol
C
Lewin
Sharyn
S
Konner
Jason
J
Derosa
Felicia
F
Spriggs
David
D
Iasonos
Alexia
A
Sabbatini
Paul
P
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*
D000726:Androgen Antagonists; D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; C053541:bicalutamide