Table 2.
Trial | Treatment arms | Overall survival | Progression-free survival or TTP | ||||
N | Median (mo) | Statistical comparison | N | Median (mo) | Statistical comparison | ||
Tannock, 2004 [64] | docetaxel q 3 wks prednisone | 335 | 18.9 | HR = 0.76 (95% CI, 0.62–0.94), p = 0.009 | NR | ||
docetaxel q wk prednisone | 334 | 17.4 | HR = 0.91 (95% CI, 0.75–1.11) p = 0.36 | ||||
Mitoxantrone prednisone | 337 | 16.5 | NA | ||||
Petrylak, 2004 [63] | Docectaxel EMP | 338 | 17.5 | HR = 0.80 (95% CI, 0.67–0.97) p = 0.02 | 324 | 6.3 | HR = 0.73 (95% CI, 0.63–0.86) p < 0.001 (TPP) |
Mitoxantrone prednisone | 336 | 15.6 | 324 | 3.2 | |||
Abratt, 2004 [62] | Vinorelbine hydrocortisone ± AGM | 206 | 14.7 | p = 0.95 | 206 | 3.7 | HR = 0.71 p = 0.055 (unadjusted) p = 0.005 (adjusted)* |
hydrocortisone ± AGM | 208 | 15.2 | 208 | 2.8 | |||
Berry, 2001 [84] | paclitaxel EMP | 166 | 15.1 | p = 0.11 | 166 | NR | p = 0.08 |
Paclitaxel | 12.9 | ||||||
Hudes, 1999 [61] | vinblastine EMP | 95 | 11.9 | p = 0.08 | 98 | 3.7 | p < 0.0004† (TTP) |
Vinblastine | 98 | 9.2 | 95 | 2.2 | |||
Iversen, 1997 [65] | EMP | 61 | 9.4 | p = 0.09 | 60 | 2.2 | |
Placebo | 68 | 6.1 | 67 | 5.0 | |||
Johansson, 1991 [66] | EMP | 51 | NR | p = 0.23 | 51 | NR | p = 0.28 |
MPA | 51 | 51 | |||||
De Kernion, 1988 [67] | EMP | 102 | NR | p = NS | 102 | NR | p = NS |
Flutamide | 101 | 101 | |||||
Murphy, 1979 [68] | EMP prednimustine | 54 | 9.3 | p = NS | NR | ||
prednimustine | 62 | 9.0 |
*Adjusted for age, baseline hemoglobin, performance status, and alkaline phosphatase, and number of prior hormonal manipulations; †based on one-sided significance testing.
Abbreviations: AGM – aminoglutethimide; CI – confidence interval; EMP – estramustine phosphate; HR – hazard ratio; mo – months; MPA – medroxyprogesterone acetate; N – number; NA – not applicable; NR – not reported; NS – non-significant; q – every; TTP – time-to-progression; wk(s) – week(s).