title: [Docetaxel plus prednisone versus mitoxantrone plus prednisone as first-line chemotherapy for metastatic hormone-refractory prostate cancer: long-term effects and safety].
abstract: OBJECTIVE
  To compare docetaxel plus prednisone with mitoxantrone plus prednisone as first-line chemotherapy for metastatic hormone-refractory prostate cancer (mHRPC).
  
  
  METHODS
  From January 2007 through August 2010, 62 patients with mHRPC received 5 mg of prednisone twice daily were randomly assigned to receive mitoxantrone 12 mg/m² every three weeks (group A) or 75 mg/m² every three weeks (group B). The cycles of each regimen were less than 10 times. The primary end point was overall survival. The secondary end points were the prostate-specific antigen (PSA) response rate, the duration of PSA response and the objective tumor response rate (ORR). All the t test, χ² test and Fisher's exact test were performed between 2 groups.
  
  
  RESULTS
  Thirty-one patients enrolled in group A received a median 4 cycles of regimen (range 1 - 10), whereas 30 patients enrolled in group B received a median of 7 cycles of regimen (range 2 - 10). There were 45.2% patients in group A and 70.0% in group B had PSA response (χ² = 3.85, P < 0.05). The duration time of PSA response was 121 days (range 20-323 days) in group A and 168 days (range 42 - 447 days) in group B, respectively. The ORR was 15.0(3/20) in group A and 10.3% (3/29) in group B, respectively. The median survival was 511 days (95%CI: 357 - 665 days) in group A and 833 days (95%CI: 634 - 1032 days) in group B, respectively (χ² = 4.20, P = 0.040). The incidence of thrombocytopenia in group A was higher than group B (χ² = 5.60, P = 0.018); the incidences of nausea and vomiting (χ² = 4.32, P = 0.038), diarrhea (P = 0.024), fatigue (χ² = 5.90, P = 0.015), and alopecia (χ² = 5.42, P = 0.020) in group B were higher than group A.
  
  
  CONCLUSIONS
  Docetaxel plus prednisone can lead to superior overall survival and PSA response rate in patients with mHRPC.
authors.affiliation: Department of Urology, Fudan University Shanghai Cancer Center and Department of Oncology, Fudan University Shanghai Medical College, Shanghai 200032, China.
authors.forename: Yi-jun
authors.initials: YJ
authors.lastname: Shen
authors.forename: Xiao-jie
authors.initials: XJ
authors.lastname: Bian
authors.forename: Hu-yang
authors.initials: HY
authors.lastname: Xie
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhu
authors.forename: Hai-liang
authors.initials: HL
authors.lastname: Zhang
authors.forename: Bo
authors.initials: B
authors.lastname: Dai
authors.forename: Shi-lin
authors.initials: SL
authors.lastname: Zhang
authors.forename: Xu-dong
authors.initials: XD
authors.lastname: Yao
authors.forename: Ding-wei
authors.initials: DW
authors.lastname: Ye
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009362:Neoplasm Metastasis; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy / Q000556:secondary*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D008942:Mitoxantrone; D011241:Prednisone