title: Anticancer effect of combination therapy of VP16 and fosfesterol in hormone-refractory prostate cancer.
abstract: OBJECTIVE
  We conducted the present study to evaluate the safety profile and therapeutic value of a combination of etoposide and fosfestrol for treatment of hormone-refractory prostate cancer (HRPC).
  
  
  METHODS
  Forty patients with HRPC were included in the study. The median age was 71 years (range, 50-86 years), the Gleason's score ranged from 5 to 10, and the median prostate-specific antigen level was 62.6 ng/mL (range, 4.738-30789 ng/mL). The patients received oral etoposide 25 mg/d and fosfestrol 300 mg/d.
  
  
  RESULTS
  The response rate in terms of measurable disease, serum prostate-specific antigen level, and overall evaluation was 36.8% (CR: 18.4%; PR: 18.4%), 80% (CR: 55%; PR: 25%), and 40% (CR: 20%; PR: 20%) with a median duration of response of 13.6, 13.5, and 13.5 months, respectively. An objective clinical response for overall evaluation was shown by 90% (CR: 20%; PR: 20%; SD: 50%) of the patients, with a median response duration of 15.7 months; 16 patients (40%) are currently alive without recurrence after a median follow-up period of 21.2 months. The overall survival and progression-free survival was 30.5% and 28.8% at 40 months, respectively. No grade III toxicities occurred in any of the patients. Serial measurements in 34 patients using the Functional Assessment of Cancer Therapy-Prostate showed a significant improvement in quality of life as a result of the therapy.
  
  
  CONCLUSIONS
  The combination of oral etoposide and fosfestrol is active in patients with HRPC. The regimen is tolerable and has a significant impact on quality of life as measured by the Functional Assessment of Cancer Therapy-Prostate in a limited sample of patients.
authors.affiliation: Department of Urology, Osaka Medical College, Takatsuki, Osaka 569-8686, Japan. uro004@poh.osaka-med.ac.jp
authors.forename: Haruhito
authors.initials: H
authors.lastname: Azuma
authors.forename: Takeshi
authors.initials: T
authors.lastname: Sakamoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kiyama
authors.forename: Takanobu
authors.initials: T
authors.lastname: Ubai
authors.forename: Yatsugu
authors.initials: Y
authors.lastname: Kotake
authors.forename: Teruo
authors.initials: T
authors.lastname: Inamoto
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Takahara
authors.forename: Yasuichiro
authors.initials: Y
authors.lastname: Nishimura
authors.forename: Naoki
authors.initials: N
authors.lastname: Segawa
authors.forename: Yoji
authors.initials: Y
authors.lastname: Katsuoka
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004054:Diethylstilbestrol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D064420:Drug-Related Side Effects and Adverse Reactions; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D016879:Salvage Therapy; D016019:Survival Analysis
chemical_list: D005047:Etoposide; D004054:Diethylstilbestrol; C004955:fosfestrol; D017430:Prostate-Specific Antigen