A phase II evaluation of goserelin and bicalutamide in patients with ovarian cancer in second or higher complete clinical disease remission Journal Article

Authors: Levine, D.; Park, K.; Juretzka, M.; Esch, J.; Hensley, M.; Aghajanian, C.; Lewin, S.; Konner, J.; Derosa, F.; Spriggs, D.; Iasonos, A.; Sabbatini, P.
Article 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. © 2007 American Cancer Society.
Keywords: immunohistochemistry; survival; vasculotropin; adult; cancer chemotherapy; clinical article; controlled study; treatment response; aged; disease-free survival; middle aged; cancer surgery; single nucleotide polymorphism; clinical feature; clinical trial; constipation; disease course; fatigue; diarrhea; side effect; treatment duration; disease free survival; cancer staging; outcome assessment; follow up; treatment indication; ovarian cancer; ovarian neoplasms; computer assisted tomography; multiple cycle treatment; ovary cancer; phase 2 clinical trial; neoplasm recurrence, local; anemia; antineoplastic combined chemotherapy protocols; genetic variability; genotype; combination chemotherapy; bone pain; backache; dizziness; rash; goserelin; cancer regression; disease severity; laboratory test; androgen antagonists; androgen receptor; headache; hot flush; physical examination; bicalutamide; ca 125 antigen; bone densitometry; dry skin; testosterone; anilides; nitriles; tosyl compounds; hematologic disease; aromatase; follitropin; androstenedione; androgen blockade; bloating; luteinizing hormone; consolidation therapy
Journal Title: Cancer
Volume: 110
Issue: 11
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2007-12-01
Start Page: 2448
End Page: 2456
Language: English
DOI: 10.1002/cncr.23056
PUBMED: 17918264
PROVIDER: scopus
Notes: --- - "Cited By (since 1996): 7" - "Export Date: 17 November 2011" - "CODEN: CANCA" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Douglas A Levine
    356 Levine
  2. Jason Konner
    84 Konner
  3. Paul J Sabbatini
    199 Sabbatini
  4. Alexia Elia Iasonos
    179 Iasonos
  5. Kay Jung Park
    181 Park
  6. Martee L Hensley
    220 Hensley
  7. David R Spriggs
    309 Spriggs
  8. Julie F Esch
    9 Esch
  9. Sharyn Nan Lewin
    16 Lewin
  10. Felicia A Derosa
    9 Derosa