title: Docetaxel and epirubicin compared with docetaxel and prednisone in advanced castrate-resistant prostate cancer: a randomised phase II study.
abstract: BACKGROUND
  This randomised phase II study compared the activity and safety of the combination docetaxel (D)/epirubicin (EPI) with the conventional treatment D/prednisone (P) in advanced castrate-resistant prostate cancer (CRPC) patients.
  
  
  METHODS
  Patients were randomly assigned to D 30 mg m(-2) as intravenous infusion (i.v.) and EPI 30 mg m(-2) i.v. every week (D/EPI arm), or D 70 mg m(-2) i.v. every 3 weeks and oral P 5 mg twice daily (D/P arm). Chemotherapy was administered until disease progression or unacceptable toxicity.
  
  
  RESULTS
  A total of 72 patients were enrolled in the study and randomly assigned to treatment: 37 to D/EPI and 35 to D/P. The median progression-free survival (PFS) was 11.1 months (95% CI 9.2-12.6 months) in the D/EPI arm and 7.7 months (95% CI 5.7-9.4 months) in the D/P arm (P=0.0002). The median survival was 27.3 months (95% CI 22.1-30.8 months) in the D/EPI arm and 19.8 months (95% CI 14.4-24.8 months) in the D/P arm (P=0.003). Both regimens were generally well tolerated.
  
  
  CONCLUSIONS
  The treatment of advanced CRPC with weekly D combined with weekly EPI was feasible and tolerable, and led to superior PFS than the treatment with 3-weekly D and oral P.
authors.affiliation: Medical Oncology Unit, University of Siena, Viale Bracci 11, 53100, Siena, Italy. r.petrioli@ao-siena.toscana.it
authors.forename: R
authors.initials: R
authors.lastname: Petrioli
authors.forename: A
authors.initials: A
authors.lastname: Pascucci
authors.forename: R
authors.initials: R
authors.lastname: Conca
authors.forename: G
authors.initials: G
authors.lastname: Chiriacò
authors.forename: E
authors.initials: E
authors.lastname: Francini
authors.forename: G
authors.initials: G
authors.lastname: Bargagli
authors.forename: A I
authors.initials: AI
authors.lastname: Fiaschi
authors.forename: A
authors.initials: A
authors.lastname: Manganelli
authors.forename: G
authors.initials: G
authors.lastname: De Rubertis
authors.forename: G
authors.initials: G
authors.lastname: Barbanti
authors.forename: R
authors.initials: R
authors.lastname: Ponchietti
authors.forename: G
authors.initials: G
authors.lastname: Francini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D043823:Taxoids; D017211:Treatment Failure
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D011241:Prednisone