title: Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone.
abstract: OBJECTIVE
  Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms.
  
  
  METHODS
  Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions.
  
  
  RESULTS
  Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms.
  
  
  CONCLUSIONS
  DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.
authors.affiliation: University of Washington, Seattle, WA 98195-7266, USA. donnalb@u.washington.edu
authors.forename: Donna L
authors.initials: DL
authors.lastname: Berry
authors.forename: Carol M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: Caroline S
authors.initials: CS
authors.lastname: Jiang
authors.forename: Donna Pauler
authors.initials: DP
authors.lastname: Ankerst
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: Lynne V
authors.initials: LV
authors.lastname: Vinson
authors.forename: Primo N
authors.initials: PN
authors.lastname: Lara
authors.forename: Sharon
authors.initials: S
authors.lastname: Jones
authors.forename: Mary E
authors.initials: ME
authors.lastname: Taplin
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Burch
authors.forename: Maha H A
authors.initials: MH
authors.lastname: Hussain
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D000077143:Docetaxel; D004961:Estramustine / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D010146:Pain / Q000209:etiology; D010147:Pain Measurement; D010166:Palliative Care; D011241:Prednisone / Q000008:administration & dosage; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine; D008942:Mitoxantrone; D011241:Prednisone