title: Significance of baseline bone markers on disease progression and survival in hormone-sensitive prostate cancer with bone metastasis.
abstract: OBJECTIVE
  This study evaluated the baseline patient characteristics associated with the time to biochemical progression and overall survival in patients who participated in a phase II trial on zoledronic acid combined with the initial androgen-deprivation therapy for treatment-naïve bone-metastatic prostate cancer.
  
  
  METHODS
  Patients received zoledronic acid 4 mg intravenously every 4 weeks for up to 24 months, concomitantly started with bicalutamide 80 mg orally every day and goserelin acetate 10.8 mg subcutaneously every 12 weeks.
  
  
  RESULTS
  A total of 53 Japanese patients were enrolled between July 2008 and April 2010, and 52 patients were evaluable. Median follow-up period was 41.6 months. Updated median time to biochemical progression was 25.9 months (95 % confidence interval 14.5-49.9). Higher serum bone-specific alkaline phosphatase was an independent risk factor for time to biochemical progression based on multivariate analysis (hazard ratio 6.51; 95 % confidence interval 2.71-15.62; P < 0.001). Median time to biochemical progression for patients with serum bone-specific alkaline phosphatase level higher than 26 μg/L was 12.7 months. Multivariate analysis indicated that higher serum C-terminal telopeptide of type I collagen independently increased the risk of death (hazard ratio 9.62; 95 % confidence interval 2.11-43.89; P = 0.003). Median overall survival for patients with serum C-terminal telopeptide of type I collagen level higher than 8.0 ng/ml was 31.1 months.
  
  
  CONCLUSIONS
  Baseline bone markers can be useful as predictors for disease progression and survival time in patients with bone metastasis from treatment-naïve prostate cancer treated with upfront zoledronic acid concomitantly started with androgen-deprivation therapy.
authors.affiliation: Department of Urology, Faculty of Medicine, Kinki University, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan, nozawa06@med.kindai.ac.jp.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nozawa
authors.forename: Isao
authors.initials: I
authors.lastname: Hara
authors.forename: Hideyasu
authors.initials: H
authors.lastname: Matsuyama
authors.forename: Masayuki
authors.initials: M
authors.lastname: Iki
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nagao
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Nishioka
authors.forename: Takahiro
authors.initials: T
authors.lastname: Komura
authors.forename: Atsunobu
authors.initials: A
authors.lastname: Esa
authors.forename: Shigeya
authors.initials: S
authors.lastname: Uejima
authors.forename: Masaaki
authors.initials: M
authors.lastname: Imanishi
authors.forename: Yasunari
authors.initials: Y
authors.lastname: Uekado
authors.forename: Takatoshi
authors.initials: T
authors.lastname: Ogawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kajikawa
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
mesh_terms: D000230:Adenocarcinoma / Q000097:blood* / Q000188:drug therapy / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood*; D000726:Androgen Antagonists / Q000008:administration & dosage; D000813:Anilides / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D014408:Biomarkers, Tumor / Q000097:blood; D001859:Bone Neoplasms / Q000097:blood / Q000401:mortality / Q000556:secondary*; D004164:Diphosphonates / Q000008:administration & dosage*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004333:Drug Administration Routes; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood* / Q000188:drug therapy / Q000473:pathology; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D014105:Tosyl Compounds / Q000008:administration & dosage*; D000077211:Zoledronic Acid
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D004164:Diphosphonates; D007093:Imidazoles; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; D000077211:Zoledronic Acid; C053541:bicalutamide; D000469:Alkaline Phosphatase; D017430:Prostate-Specific Antigen