title: Oral ethinylestradiol in castration-resistant prostate cancer: a 10-year experience.
abstract: OBJECTIVE
  To describe our 10-year experience with the use of oral ethinylestradiol in the treatment of metastatic castration-resistant prostate cancer.
  
  
  METHODS
  From February 2000 to April 2010, 116 patients with a metastatic castration-resistant prostate cancer were prospectively submitted to oral ethinylestradiol monotherapy. Inclusion criteria were: diagnosis of castration-resistant prostate cancer after failure of at least two lines of androgen deprivation therapy and radiological evidence of metastases. Exclusion criteria were: symptomatic cases with a European Cooperative Oncology Group score >2 and severe or uncontrolled cardiovascular diseases. At inclusion in the study, all patients discontinued the previous androgen deprivation therapy and started oral ethinylestradiol at the daily dose of 1 mg. Aspirin (100 mg/daily) was concomitantly given.
  
  
  RESULTS
  The median ethinylestradiol therapy duration was 15.9 months (range 8-36 months), whereas the median follow up of patients was 28 months (range 13-36 months). During ethinylestradiol therapy, a confirmed prostate-specific antigen response was found in 79 patients (70.5%). The median time to prostate-specific antigen progression was 15.10 months (95% confidence interval 13.24-18.76 months). A toxicity requiring treatment cessation was observed in 26 patients (23.2%) at a median time of 16 months (mainly thromboembolism).
  
  
  CONCLUSIONS
  Our 10-year experience shows that ethinylestradiol provides a prostate-specific antigen response in a high percentage of patients with metastatic castration-resistant prostate cancer. Cardiovascular toxicity can be managed through accurate patient selection, close follow up and a concomitant anticoagulation therapy.
authors.affiliation: Department of Urology, University Sapienza, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciarra
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Gentile
authors.forename: Susanna
authors.initials: S
authors.lastname: Cattarino
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gentilucci
authors.forename: Andrea
authors.initials: A
authors.lastname: Alfarone
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Eramo
authors.forename: Stefano
authors.initials: S
authors.lastname: Salciccia
mesh_terms: D000284:Administration, Oral; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D018450:Disease Progression; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004997:Ethinyl Estradiol; D017430:Prostate-Specific Antigen
keywords: advanced disease; castration resistant; estrogens; hormone therapy; prostate neoplasm