title: Prospective evaluation of hydrocortisone and suramin in patients with androgen-independent prostate cancer.
abstract: OBJECTIVE
  To assess efficacy of intermittent infusion of suramin in patients with androgen-independent prostate cancer who have had disease progression on hydrocortisone.
  
  
  METHODS
  Chemotherapy-naive patients with progressive androgen-independent prostate cancer were given hydrocortisone 40 mg/d and monitored for treatment effect. At the time of disease progression, suramin was administered on a pharmacokinetically derived, 2-week dosing schedule.
  
  
  RESULTS
  Thirty patients with a median Karnofsky performance status (KPS) of 90% were treated with hydrocortisone. No responses were seen in 12 patients with measurable disease or 29 patients with abnormal bone scans. Thirty patients had an increasing prostate-specific antigen (PSA) level before treatment and six (20%) had a more than 50% decline in PSA from the baseline value for a median of 16 weeks (range, 12 to 52+). Twenty-eight patients had disease progression after a median of 7 weeks (range, 3 to 23), and two patients have continued to receive hydrocortisone for 44 and 52 weeks. Twenty-eight patients received hydrocortisone and suramin, with median suramin concentrations of 97 to 170 micrograms/mL for 4 weeks. No responses in measurable disease and no improvements in bone scans were seen. Five patients (18%) showed a more than 50% decline in PSA levels from baseline, of whom three had previously responded to hydrocortisone. Only two of 24 patients who did not show a posttherapy decline in PSA levels after hydrocortisone had a reduction in PSA levels with the addition of suramin. Toxicity profiles were acceptable with each agent, although a higher proportion of subjects showed hematologic, cardiac, and neurologic events when suramin was added.
  
  
  CONCLUSIONS
  Suramin has limited efficacy in patients with androgen-independent prostate cancer who have had disease progression after hydrocortisone.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
authors.forename: W K
authors.initials: WK
authors.lastname: Kelly
authors.forename: T
authors.initials: T
authors.lastname: Curley
authors.forename: C
authors.initials: C
authors.lastname: Leibretz
authors.forename: A
authors.initials: A
authors.lastname: Dnistrian
authors.forename: M
authors.initials: M
authors.lastname: Schwartz
authors.forename: H I
authors.initials: HI
authors.lastname: Scher
mesh_terms: D000368:Aged; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism; D012074:Remission Induction; D013498:Suramin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D013739:Testosterone / Q000378:metabolism*
chemical_list: D013739:Testosterone; D013498:Suramin; D017430:Prostate-Specific Antigen; D006854:Hydrocortisone