Table 1.
Baseline Characteristics of the Intention to Treat Population
| Characteristic | TAS-102 + Oxaliplatin (N = 41) |
|---|---|
| Age | |
| Median | 62 |
| Range | 42 – 83 |
| Sex – no. (%) | |
| Male | 26 (63) |
| Female | 15 (37) |
| Race – no. (%) | |
| White | 38 (93) |
| Black | 1 (2) |
| Asian | 2 (5) |
| ECOG performance status – no. (%) | |
| 0 | 25 (61) |
| 1 | 16 (39) |
| Location of primary tumor – no. (%) | |
| Left side of colon, including rectum | 31 (76) |
| Right side of colon | 10 (24) |
| Stage at diagnosis – no. (%) | |
| I | 1 (2) |
| II | 2 (5) |
| III | 13 (32) |
| IV | 25 (61) |
| Histology – no. (%) | |
| Well differentiated | 2 (5) |
| Moderately differentiated | 30 (73) |
| Poorly differentiated | 9 (22) |
| High microsatellite instability – no. (%) | 2 (5) |
| KRAS / BRAF mutation – no. (%) | |
| KRAS mutation | 20 (49) |
| BRAF mutation | 1 (2) |
| Wildtype | 20 (49) |
| Number of prior therapies – no. (%) | |
| 1 | 1 (2) |
| 2 | 18 (44) |
| 3 | 15 (37) |
| ≥ 4 | 7 (17) |
| Progression during prior oxaliplatin – no. (%) | |
| Yes | 18 (44) |
| No1 | 23 (56) |
1
Includes 4 patients who received adjuvant oxaliplatin and 19 patients with progression on maintenance 5-FU based therapy after oxaliplatin discontinuation.