| Trial VIII | Trial IX | Pooled Trials | |||
---|---|---|---|---|---|---|
p53 | Analyzed | Not analyzed | Analyzed | Not analyzed | Analyzed | Not analyzed |
Number of patients | 417 | 646 | 696 | 973 | 1,113 | 1,619 |
Median age (range) | 46 | 45 | 61 | 60 | Â | Â |
 | (26 to 58) | (22 to 56) | (42 to 77) | (34 to 81) |  |  |
 |  | ns |  | ns |  |  |
ER status, n | Â | Â | Â | Â | Â | Â |
Absent | 84 | 101 | 128 | 137 | 212 | 238 |
> = 1% | 322 | 360 | 558 | 516 | 880 | 876 |
Missing | 11 | 185 | 10 | 320 | 21 | 505 |
 |  | ns1 |  | ns |  |  |
Tumor size, n | Â | Â | Â | Â | Â | Â |
0 to 1 cm | 27 | 99 | 65 | 136 | 92 | 235 |
> 1 to 2 cm | 206 | 321 | 333 | 450 | 539 | 771 |
> 2 cm | 182 | 217 | 280 | 352 | 462 | 569 |
Missing | 2 | 9 | 18 | 35 | 20 | 44 |
 |  | P < 0.0001 |  | P = 0.01 |  |  |
Tumor grade, n | Â | Â | Â | Â | Â | Â |
 | 52 | 94 | 85 | 160 | 137 | 254 |
1 | 171 | 286 | 304 | 447 | 475 | 733 |
2 | 168 | 179 | 248 | 261 | 416 | 440 |
3 | 26 | 87 | 59 | 105 | 85 | 192 |
Missing | Â | P = 0.002 | Â | P = 0.0004 | Â | Â |
10-year DFS | 71.3% | 76.0% P = 0.152 | 67.6% | 75.5% P = 0.10 | Â | Â |
10-year OS | 86.4% | 87.4% P = 0.44 | 81.1% | 83.8% P = 0.65 | Â | Â |