title: A randomized comparative study of endocrine monotherapy and a combination of estramustine phosphate with the endocrine therapy in patients with untreated stage D prostate cancer.
abstract: BACKGROUND
  We investigated the clinical efficacy and the prolongation of survival with combination therapy of estramustine phosphate (EMP) and endocrine therapy in untreated patients with progressive prostate cancer.
  
  
  METHODS
  We randomly divided 57 patients with untreated stage D prostate cancer into two groups, an endocrine monotherapy group and a group receiving combination treatment, consisting of endocrine therapy plus EMP. Treatment was continued until deterioration.
  
  
  RESULTS
  There were no significant differences in the improvement rating for subjective/objective symptoms or in progression-free survival between the two groups. However, overall survival was significantly prolonged in the combination therapy group (log-rank test, P = 0.0394; generalized Wilcoxon's test, P = 0.0145). In particular, overall survival was significantly prolonged, compared to that in the endocrine monotherapy group, in patients in the combination therapy group who were less than 74 years old, those with a performance status (PS) of 1 to 3, a pretreatment prostate-specific antigen (PSA) level of more than 20 ng/ml, moderately or poorly differentiated carcinoma, or a partial response (PR) based on the PSA level 12 weeks after the start of treatment. There was no significant difference in the incidence of side effects between the combination therapy and the endocrine monotherapy groups.
  
  
  CONCLUSIONS
  A combination of EMP with endocrine therapy may be useful for initial treatment in younger patients (aged 73 or younger) and in patients at high risk of progressive prostate cancer.
authors.affiliation: Department of Urology, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata 990-2292, Japan. hoshi@ypch.gr.jp
authors.forename: Senji
authors.initials: S
authors.lastname: Hoshi
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Fujioka
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Arai
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Tomonori
authors.initials: T
authors.lastname: Habuchi
authors.forename: Chikara
authors.initials: C
authors.lastname: Ohyama
authors.forename: Tadashi
authors.initials: T
authors.lastname: Suzuki
authors.forename: Seiichi
authors.initials: S
authors.lastname: Orikasa
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004961:Estramustine / Q000008:administration & dosage*; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D007987:Gonadotropin-Releasing Hormone; D004961:Estramustine