Table 1 Baseline patient characteristics: Intention-to-treat population (n = 274) and translational study population (n = 153)
Parameter | Intention-to-treat | Translational | ||||||
|---|---|---|---|---|---|---|---|---|
Gem + E (n = 143) | Cap + E (n = 131) | Gem + E (n = 85) | Cap + E (n=68) | |||||
No. | % | No. | % | No. | % | No. | % | |
Age [years] | ||||||||
Median | 65 | 63 | 63 | 64 | ||||
Range | 32 - 78 | 38 - 75 | 32 - 75 | 42 - 75 | ||||
Gender | ||||||||
Male | 82 | 57 | 83 | 63 | 49 | 58 | 41 | 60 |
Female | 61 | 43 | 48 | 37 | 36 | 42 | 27 | 40 |
Stage of disease | ||||||||
Locally advanced | 21 | 15 | 22 | 17 | 13 | 15 | 13 | 19 |
Metastatic | 122 | 85 | 109 | 83 | 72 | 85 | 55 | 81 |
Performance status | ||||||||
KPS 60-80% | 50 | 35 | 49 | 37 | 29 | 34 | 30 | 44 |
KPS 90-100% | 85 | 59 | 79 | 60 | 50 | 59 | 38 | 56 |
Missing | 8 | 6 | 3 | 2 | 6 | 7 | 0 | 0 |
Previous surgery | 8 | 6 | 17 | 13 | 7 | 8 | 8 | 12 |
Weight loss during three | ||||||||
months before | ||||||||
randomisation [kg] | ||||||||
Median | 5 | 7 | 5.5 | 7 | ||||
Range | 0 - 47 | 0 - 45 | 0 - 20 | 0 - 35 | ||||
Baseline CA 19–9 [U/ml]1 | ||||||||
Median | 1999 | 1756 | 2632 | 1255 | ||||
Range | 1 - 700000 | 1 - 1000000 | 2 - 700000 | 1 - 1000000 | ||||