Table 1.
Patients characteristics
| Characteristics | n (%) |
DL1 |
DL2* |
DL3 |
|---|---|---|---|---|
| n | n | n | ||
|
Total patient number |
20 (100) |
7 |
7 |
6 |
|
Gender |
|
|
|
|
| Male |
15 (75) |
4 |
6 |
5 |
| Female |
5 (25) |
3 |
1 |
1 |
|
Age |
|
|
|
|
| Median Age – years (range) |
59 (34–72 ) |
57 (34–72) |
64 (43–67) |
57 (44–69) |
|
ECOG PS |
|
|
|
|
| ECOG PS 0 |
15 (75) |
5 |
7 |
3 |
|
Primary tumor site |
|
|
|
|
| Colon |
10 (50) |
4 |
5 |
1 |
| Rectum |
10 (50) |
3 |
2 |
5 |
|
Previous adjuvant therapy |
|
|
|
|
| None |
17 (85) |
4 |
7 |
6 |
| 5-FU (infusional) |
3 (15) |
3 |
0 |
0 |
| 5-FU (bolus) |
1 (5) |
1 |
0 |
0 |
| Oxaliplatin |
2 (10) |
2 |
0 |
0 |
|
Number of metastatic sites |
|
|
|
|
| Median number (range) |
1.75 (1–3) |
2.1 (1–3) |
1.7 (1–3) |
1.3 (1–2) |
|
KRAS status (retrospective) |
|
|
|
|
| Wild type |
14 (70) |
6 |
3 |
5 |
| Mutant | 6 (30) | 1 | 4 | 1 |
*One further patient in this dose level was excluded from all analyses owing to i.v. port-catheter dysfunction during the first dose.