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Table 9 Non-cytotoxic trials: survival outcomes.

From: Non-hormonal systemic therapy in men with hormone-refractory prostate cancer and metastases: a systematic review from the Cancer Care Ontario Program in Evidence-based Care's Genitourinary Cancer Disease Site Group

Trial Treatment arms Overall survival Progression-free survival or TTP or FFS
   N Median (mo) Statistical comparison N Median (mo) Statistical comparison
Carducci, 2004 [85] Atrasentan NR 408 NR HR for TTP = 1.14 (95% CI, 0.98–1.34) p = 0.091
  placebo     401   
Carducci, 2003 [79] atrasentan 10 mg NR 89 6.5 p = 0.13 (TTP)
  atrasentan 2.5 mg     95 6.4 p = 0.29 (TTP)
  placebo     104 4.9 NA
Small, 2003 [86] APC8015 NR 82 NR HR for TTP = 1.39 (95% CI, 0.95–2.04) p = 0.085
  placebo     45   
Small, 2002 [81] suramin (3.192 g/m2) 128 16 p = 0.49 128 NR p = NS
  suramin (5.320 g/m2) 124 14   124   
  suramin (7.661 g/m2) 120 13   120   
Ahmann, 2001 [87] prinomastat (5 mg) mitoxantrone prednisone 134 15.1 p = NS 134 6 p = NS
  prinomastat (10 mg) mitoxantrone prednisone 134 14.7   134 4.7  
  mitoxantrone prednisone placebo 138 14.8   138 6  
Small, 2000 [82] suramin hydrocortisone 228 10.2 p = NS 228 NR RR for TTP = 1.51 (95% CI, 1.22–1.85) p = 0.0003
  placebo hydrocortisone 230 10   230   
Debruyne, 1998 [83] liarozole 160 10.3 p = 0.52 HR = 0.74* (95% CI, 0.56–0.99) p = 0.039 160 4.9 p = NS
  CPA 161 10.3   161 4.6  
  1. *Adjusted for performance status, hemoglobin, baseline PSA, alkaline phosphatase, and duration of response.
  2. Abbreviations: CI – confidence interval; CPA – cyproterone acetate; DES – diethylstilbestrol; FFS – failure-free survival; HR – hazard ratio; m2 - meters squared; mg – milligrams; mo – months; N – number; NA – not applicable; NR – not reported; NS – non-significant; RR – relative risk; TTP – time-to-progression.