title: Weekly docetaxel and prednisolone versus prednisolone alone in androgen-independent prostate cancer: a randomized phase II study.
abstract: BACKGROUND
  Due to its palliative effect and prostate-specific antigen (PSA) decrease, many clinicians have considered prednisolone monotherapy to be the standard systemic treatment in patients with androgen-independent prostate cancer (AIPC). This approach should be compared with docetaxel (Taxotere)+prednisolone.
  
  
  METHODS
  A total of 109 eligible patients were entered into a randomized phase II study (arm A: Taxotere+prednisolone [30 mg m(-2) weekly during 5 of 6 wk+prednisolone 5 mg x 2 per os daily]; arm B: prednisolone [5 mg x 2 per os daily]). Biochemical response (confirmed > or = 50% PSA reduction of the baseline level at 6 wk) was the primary endpoint with subjective progression, quality of life, and progression-free and overall survival as secondary outcomes.
  
  
  RESULTS
  Biochemical response at 6 wk was recorded in 29 of 54 evaluable patients in arm A (54%; 95% CI: 40-67%) and 13 of 50 patients in arm B (26%; 95% CI: 14-38%), with similar response rates at 12 wk and if based on all eligible patients. Median progression-free survival was 11 mo (95% CI: 5.8-16.2 mo) in arm A and 4 mo in arm B (95% CI: 2.4-5.6 mo). Median overall survival was 27 mo in arm A (95% CI: 19.8-34.1 mo) and 18 mo in arm B (95% CI: 15.2-20.8 mo). Pain relief and quality-of-life assessment indicated superiority of the arm A treatment, without unacceptable toxicity.
  
  
  CONCLUSIONS
  Docetaxel+prednisolone should become the first-line systemic standard treatment for AIPC as a more effective treatment than prednisolone monotherapy. Weekly applications of docetaxel are well tolerated.
authors.affiliation: Department of Clinical Cancer Research, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway. sophie.dorothea.fossa@radiumhospitalet.no
authors.forename: Sophie D
authors.initials: SD
authors.lastname: Fosså
authors.forename: Anne-Birgitte
authors.initials: AB
authors.lastname: Jacobsen
authors.forename: Claes
authors.initials: C
authors.lastname: Ginman
authors.forename: Inga N
authors.initials: IN
authors.lastname: Jacobsen
authors.forename: Sissel
authors.initials: S
authors.lastname: Overn
authors.forename: Jon R
authors.initials: JR
authors.lastname: Iversen
authors.forename: Thomas
authors.initials: T
authors.lastname: Urnes
authors.forename: Alv A
authors.initials: AA
authors.lastname: Dahl
authors.forename: Marijke
authors.initials: M
authors.lastname: Veenstra
authors.forename: Berit
authors.initials: B
authors.lastname: Sandstad
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D011239:Prednisolone