title: A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer.
abstract: OBJECTIVE
  To explore the feasibility and efficacy of docetaxel plus prednisone for Chinese population with metastatic castration refractory prostate cancer (mCRPC).
  
  
  METHODS
  A total of 228 patients recruited from 15 centers were randomized to receive 10 cycles of D3P arm (docetaxel: 75 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily) or M3P arm (mitoxantrone: 12 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily). Primary end point was overall survival, and secondary end points were events progression-free survival (PFS), response rate, response duration. Quality of life (QoL) was also assessed in both treatment groups.
  
  
  RESULTS
  The median overall survival was 21.88 months in D3P arm and 13.67 months in M3P arm (P = 0.0011, hazard ratio = 0.63, 95% confidence interval, 0.46-0.86). Subgroup analysis was consistent with the results of overall analysis. Events progression-free survival (pain, PSA, tumor and disease) were significantly improved in D3P arm compared with M3P arm. PSA response rate was 35.11% for patients treated by D3P arm and 19.39% for M3P arm (P = 0.0155). Pain response rate was higher in D3P arm (61.11%, P = 0.0011) than in M3P (23.08%) arm. No statistical differences were found between D3P arm and M3P arm for QoL, tumor response rate and response duration of PSA and pain. The tolerability and overall safety of D3P arm were generally comparable to that of M3P arm.
  
  
  CONCLUSIONS
  Compared with M3P arm, D3P arm significantly prolonged overall survival for the Chinese patients with mCRPC and improved the response rate for PSA and pain.
  
  
  BACKGROUND
  clinicaltrials.gov NCT00436839.
authors.affiliation: Department of Urology, Changhai Hospital, The Second Military Medical University, 168 Changhai Road, Shanghai 200433, P.R. China.
authors.forename: Tie
authors.initials: T
authors.lastname: Zhou
authors.affiliation: Department of Urology, Changhai Hospital, The Second Military Medical University, 168 Changhai Road, Shanghai 200433, P.R. China.
authors.forename: Shu-xiong
authors.initials: SX
authors.lastname: Zeng
authors.affiliation: Department of Urology, Shanghai Cancer Center, Fudan University, Shanghai, P.R. China.
authors.forename: Ding-wei
authors.initials: DW
authors.lastname: Ye
authors.affiliation: Department of Urology, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, P.R. China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Wei
authors.affiliation: Department of Urology, Chinese PLA General Hospital, Medical School of Chinese PLA, Beijing, P.R. China.
authors.forename: Xu
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, P.R. China.
authors.forename: Yi-ran
authors.initials: YR
authors.lastname: Huang
authors.affiliation: Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, P.R. China.
authors.forename: Zhang-qun
authors.initials: ZQ
authors.lastname: Ye
authors.affiliation: Department of Urology, Beijing Cancer Hospital, Peking University, Beijing, P.R. China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Urology, Jiangsu Province Hospital, Nanjing Medical University, Nanjing, P.R. China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, P.R. China.
authors.forename: Ye
authors.initials: Y
authors.lastname: Tian
authors.affiliation: Department of Urology, Cancer Hospital, Sun Yat-Sen University, Guangzhou, P.R. China.
authors.forename: Fang-jian
authors.initials: FJ
authors.lastname: Zhou
authors.affiliation: Department of Urology, Peking University First Hospital, Beijing, P.R. China.
authors.forename: Jin
authors.initials: J
authors.lastname: Jie
authors.affiliation: Department of Urology, Fujian Union Hospital, Fuzhou, P.R. China.
authors.forename: Shi-ping
authors.initials: SP
authors.lastname: Chen
authors.affiliation: Department of Urology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, P.R. China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Urology, the First Affiliated Hospital, Zhejiang University, Hangzhou, P.R. China.
authors.forename: Li-ping
authors.initials: LP
authors.lastname: Xie
authors.affiliation: Department of Urology, Tianjin Cancer Hospital, Tianjin Medical University, Tianjin, P.R. China.
authors.forename: Xing
authors.initials: X
authors.lastname: Yao
authors.affiliation: Department of Urology, Shougang Hospital, Peking University, Beijing, P.R. China.
authors.forename: Yan-qun
authors.initials: YQ
authors.lastname: Na
authors.affiliation: Department of Urology, Changhai Hospital, The Second Military Medical University, 168 Changhai Road, Shanghai 200433, P.R. China.
authors.forename: Ying-hao
authors.initials: YH
authors.lastname: Sun
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002681:China; D018572:Disease-Free Survival; D000077143:Docetaxel; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D008942:Mitoxantrone; D011241:Prednisone