Table 1. Baseline patient characteristics (ITT population).
FOLFOX4 (n=317)
|
FOLFOX4- placebo (n=351)
|
FOLFOX4- bevacizumab (n=349)
|
XELOX (n=317)
|
XELOX- placebo (n=350)
|
XELOX- bevacizumab (n=350)
|
|||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Characteristic | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % |
Gender | ||||||||||||
Male | 204 | 64 | 186 | 53 | 205 | 59 | 194 | 61 | 205 | 59 | 213 | 61 |
Female | 113 | 36 | 165 | 47 | 144 | 41 | 123 | 39 | 145 | 41 | 137 | 39 |
Age, years | ||||||||||||
Median | 62 | 60 | 60 | 61 | 61 | 61 | ||||||
Range | 24–83 | 26–83 | 19–82 | 24–84 | 18–83 | 18–86 | ||||||
ECOG performance status | ||||||||||||
0 | 163 | 51 | 211 | 60 | 198 | 57 | 160 | 50 | 207 | 59 | 207 | 59 |
1 | 154 | 49 | 138 | 40 | 147 | 43 | 157 | 50 | 143 | 41 | 142 | 41 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | <1 |
Primary tumour site | ||||||||||||
Colorectal | 17 | 5 | 25 | 7 | 28 | 8 | 30 | 9 | 30 | 9 | 32 | 9 |
Colon | 200 | 63 | 232 | 66 | 223 | 64 | 204 | 64 | 233 | 67 | 236 | 67 |
Rectal | 100 | 32 | 94 | 27 | 98 | 28 | 83 | 26 | 87 | 25 | 82 | 23 |
Stage at first diagnosis | ||||||||||||
Local regional | 144 | 45 | 141 | 40 | 128 | 37 | 133 | 42 | 138 | 39 | 122 | 35 |
Metastatic | 173 | 55 | 210 | 60 | 221 | 63 | 184 | 58 | 212 | 61 | 228 | 65 |
Number of metastatic sites | ||||||||||||
0 | 1 | 0.3 | 1 | 0.3 | 1 | 0.3 | 0 | 0 | 0 | 0 | 0 | 0 |
1 | 118 | 37.2 | 142 | 40.5 | 150 | 43.0 | 127 | 40.1 | 155 | 44.3 | 134 | 38.3 |
2 | 121 | 38.2 | 122 | 34.8 | 132 | 37.8 | 106 | 33.4 | 112 | 32.0 | 121 | 34.6 |
3 | 47 | 14.8 | 65 | 18.5 | 44 | 12.6 | 55 | 17.4 | 58 | 16.6 | 64 | 18.3 |
⩾4 | 30 | 9.5 | 21 | 6.0 | 22 | 6.3 | 29 | 9.1 | 25 | 7.1 | 31 | 8.9 |
Alkaline phosphatase | ||||||||||||
Abnormal | 135 | 43 | 147 | 42 | 146 | 42 | 132 | 42 | 149 | 43 | 156 | 45 |
Normal | 182 | 57 | 201 | 58 | 199 | 58 | 183 | 58 | 200 | 57 | 191 | 55 |
Previous adjuvant therapy | ||||||||||||
No | 234 | 74 | 266 | 76 | 261 | 75 | 229 | 72 | 259 | 74 | 274 | 78 |
Yes | 83 | 26 | 85 | 24 | 88 | 25 | 88 | 28 | 91 | 26 | 76 | 22 |
Abbreviations: ITT=intent-to-treat; ECOG=Eastern Cooperative Oncology Group; FOLFOX4=infused fluorouracil, folinic acid and oxaliplatin; XELOX=capecitabine and oxaliplatin.