Table 1.
Baseline characteristics in the intention-to-treat population
| Variable | FOLFOX plus bevacizumab (n=177) | FOLFOXIRI plus bevacizumab (n=172) |
| Age (years) | 59 (53–65) | 61 (54–66) |
| Sex | ||
| Male | 119 (67.2%) | 118 (68.6%) |
| Female | 58 (32.8%) | 54 (31.4%) |
| ECOG performance status | ||
| 0 | 85 (48.0%) | 81 (47.1%) |
| 1 | 92 (52.0%) | 91 (52.9%) |
| Tumour localisation | ||
| Colon | 108 (61.0%) | 113 (65.7%) |
| Rectum | 48 (27.1%) | 38 (22.1%) |
| Colorectal | 21 (11.9%) | 21 (12.2%) |
| Site of primary tumour | ||
| Left colon | 137 (77.4%) | 119 (69.2%) |
| Right colon | 39 (22.0%) | 48 (28.0%) |
| Both | 1 (0.6%) | 5 (2.9%) |
| Site of metastases | ||
| Liver only | 62 (35.0%) | 62 (36.1%) |
| Multiple sites | 115 (65.0%) | 110 (64.0%) |
| Metastatic sites | ||
| ≤1 | 65 (36.7%) | 68 (39.5%) |
| >1 | 112 (63.3%) | 104 (60.5%) |
| Presentation | ||
| Synchronous | 167 (94.4%) | 160 (93.0%) |
| Metachronous | 10 (5.7%) | 12 (7.0%) |
| Prior treatment | ||
| Surgery | 55 (31.0%) | 59 (34.3%) |
| Radiotherapy | 4 (2.3%) | 5 (2.9%) |
| Chemotherapy* | 7 (4.0%) | 9 (5.2%) |
| CEA levels | ||
| ≤5 ng/mL | 8 (4.5%) | 16 (9.3%) |
| >5 ng/mL | 169 (95.5%) | 156 (90.7%) |
| RAS status | ||
| Mutated† | 84 (47.5%) | 85 (49.4%) |
| Wildtype | 88 (49.7%) | 85 (49.4%) |
| Data not available | 5 (2.8%) | 2 (1.2%) |
| PI3K status | ||
| Mutated | 17 (9.6%) | 26 (15.1%) |
| Wildtype | 159 (89.8%) | 146 (84.9%) |
| Data not available | 1 (0.6%) | 0 (0%) |
| BRAF status | ||
| Mutated | 17 (9.6%) | 16 (9.3%) |
| Wildtype | 160 (90.4%) | 156 (90.7%) |
| MSI | ||
| MSI high | 1 (0.6%) | 2 (1.2%) |
| MSI low | 7 (4.0%) | 8 (4.7%) |
| MSS | 156 (88.1%) | 156 (90.7%) |
| Data not available | 13 (7.3%) | 6 (3.5%) |
Data are no (%) or median (IQR).
*Adjuvant or neoadjuvant setting.
†Mutated in KRAS (exon 2, 3 or 4) or NRAS (exon 2, 3, or 4).
CEA, carcinoembryonic antigen; ECOG, Eastern Cooperative Oncology Group; FOLFOX, 5-fluorouracil, leucovorin and oxaliplatin; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin and irinotecan; MSI, microsatellite instability; MSS, microsatellite stable.