Table 1.
Patient and tumor characteristics by treatment arm
| Characteristics | All enrolled | Arm A (n=12) | Arm B (n=11) | P-value | |||
|---|---|---|---|---|---|---|---|
| Number | Percent | Number | Percent | Number | Percent | ||
| Gender | 0.32 | ||||||
| Male | 18 | 78.3 | 8 | 66.7 | 10 | 90.9 | |
| Female | 5 | 21.7 | 4 | 33.3 | 1 | 9.1 | |
| Median age (range) | 59 (42–78) | 59 (45–78) | 58 (42–74) | 0.6 | |||
| Race/ethnicity | 0.093 | ||||||
| Caucasian | 19 | 82.6 | 8 | 66.7 | 11 | 100 | |
| African American | 4 | 17.4 | 4 | 33.3 | 0 | 0 | |
| Performance status | 0.0028 | ||||||
| 0 | 13 | 56.6 | 3 | 25 | 10 | 90.9 | |
| 1 | 10 | 43.4 | 9 | 75.0 | 1 | 9.1 | |
| Adjuvant therapy | |||||||
| Yes | 2 | 8.6 | 0 | 0 | 2 | 18 | 0.22 |
| No | 21 | 91.3 | 12 | 100 | 9 | 82 | |
| Sites of metastases | |||||||
| Liver | 17 | 74 | 6 | 50 | 11 | 100 | 0.014 |
| Lung | 11 | 48 | 7 | 58 | 4 | 36 | 0.41 |
| Abdominal lymph nodes | 9 | 39 | 5 | 42 | 4 | 36 | 1.00 |
| 1–2 metastatic sites | 18 | 78 | 9 | 75 | 9 | 82 | 1.00 |
| >3 Metastatic sites | 5 | 22 | 3 | 25 | 2 | 18 | |
| Correlative studiesa | |||||||
| KRAS wild type | 15 | 75 | 7 | 70 | 8 | 80 | 0.5 |
| KRAS mutant | 5 | 25 | 3 | 30 | 2 | 20 | |
a
The correlative studies were assessed retrospectively following study completion on 20 patients for whom tissue samples were available (ten patients from each study arm).
The numbers in bold represent statistical significance P<0.05