title: Docetaxel, with or without estramustine phosphate, as first-line chemotherapy for hormone-refractory prostate cancer: results of a multicentre, randomized phase II trial.
abstract: OBJECTIVE
  To report the results of a randomized phase II trial of docetaxel with and without estramustine phosphate (EP) in patients with hormone-refractory prostate cancer (HRPC).
  
  
  METHODS
  Patients with progressive HRPC were randomized to receive docetaxel 70 mg/m(2) on day 1 (arm A), or docetaxel 70 mg/m(2) on day 2 plus oral EP three times daily, at a total daily dose of 840 mg, on days 1-5 (arm B). The primary objective of the trial was to evaluate the activity of the treatments in terms of the response in prostate-specific antigen (PSA) level.
  
  
  RESULTS
  Forty-five of the 49 patients centrally randomized to arm A and 44 of the 46 in arm B were evaluable for activity. The PSA level decreased by > or =50% in 40% of the patients in arm A and in 75% of those in arm B. The median time to PSA progression was 20 weeks in arm A and 30 weeks in arm B. The patients in arm B had an improvement in pain over time.
  
  
  CONCLUSIONS
  These data support the existence of a possible advantage in combining docetaxel and EP, which should be verified in a specific randomized phase III study.
authors.affiliation: Medical Oncology Department, University of Verona, Verona, Italy. orazio.caffo@apss.tn.it
authors.forename: Orazio
authors.initials: O
authors.lastname: Caffo
authors.forename: Teodoro
authors.initials: T
authors.lastname: Sava
authors.forename: Evi
authors.initials: E
authors.lastname: Comploj
authors.forename: Annamaria
authors.initials: A
authors.lastname: Fariello
authors.forename: Fable
authors.initials: F
authors.lastname: Zustovich
authors.forename: Romana
authors.initials: R
authors.lastname: Segati
authors.forename: Cosimo
authors.initials: C
authors.lastname: Sacco
authors.forename: Francesco
authors.initials: F
authors.lastname: Valduga
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Cetto
authors.forename: Enzo
authors.initials: E
authors.lastname: Galligioni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D004961:Estramustine / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine; D017430:Prostate-Specific Antigen