title: Androgen deprivation and four courses of fixed-schedule suramin treatment in patients with newly diagnosed metastatic prostate cancer: A Southwest Oncology Group Study.
abstract: OBJECTIVE
  To assess the feasibility of administering a combination of suramin and hydrocortisone in addition to androgen deprivation in a cooperative group setting; to assess the feasibility of treatment with multiple courses of suramin; and to assess progression-free and overall survival in patients with newly diagnosed metastatic prostate cancer who underwent such treatment.
  
  
  METHODS
  Patients with newly diagnosed metastatic prostate cancer who had adequate hematologic, hepatic, renal, neurologic, and coagulation parameters were treated by combined androgen deprivation and suramin plus hydrocortisone. Suramin was administered on a 78-day fixed dosing schedule (one cycle), and suramin treatment cycles were repeated every 6 months for a total of four cycles. The statistical design was developed on the basis of the feasibility of administering suramin, as judged by the number of patients who developed neurotoxicity of grade 3 or higher or by treatment interruption of 4 weeks or longer due to any persistent suramin-related toxicity.
  
  
  RESULTS
  Of the 62 patients enrolled onto the study between August 1994 and January 1997, 59 were eligible and assessable for toxicity on the first cycle. Thirty-two (54%) of 59 patients received a second cycle, 13 (22%) of 59 patients received a third cycle, and only five patients (8%) received a fourth cycle. During the first cycle, 27 patients were removed from the study: 17 because of toxicity, five because of disease progression, two who had died, and three because of other reasons. There was one therapy-related death. Grade 4 toxicities were noted in 11 and three patients during first and second courses, respectively. Neurotoxicity of grade 3 or higher was observed in nine and seven patients during the first and second cycles, respectively. Fifteen patients had treatment interruptions of 4 weeks or longer. Overall, only 54% (95% confidence interval, 41% to 67%) of the patients demonstrated acceptable limits of toxicity.
  
  
  CONCLUSIONS
  Suramin plus hydrocortisone and androgen deprivation has limited applicability in the treatment of patients with newly diagnosed metastatic prostate cancer.
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Barbara Ann Karmanos Cancer Institute and Wayne State University, Detroit, MI, USA.
authors.forename: M
authors.initials: M
authors.lastname: Hussain
authors.forename: E I
authors.initials: EI
authors.lastname: Fisher
authors.forename: D P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: J
authors.initials: J
authors.lastname: O'Connor
authors.forename: D P
authors.initials: DP
authors.lastname: Wood
authors.forename: E J
authors.initials: EJ
authors.lastname: Small
authors.forename: M A
authors.initials: MA
authors.lastname: Eisenberger
authors.forename: E D
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000368:Aged; D000728:Androgens / Q000172:deficiency / Q000378:metabolism*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D017273:Goserelin / Q000627:therapeutic use; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use; D016729:Leuprolide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D013498:Suramin / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D013498:Suramin; D016729:Leuprolide; D006854:Hydrocortisone