Table 1 Baseline demographics and disease characteristics
From: Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial
EC + mFOLFOX6 (n = 236) | SOC (n = 243) | Total (n = 479) | |
---|---|---|---|
Median age (range), years | 60.0 (24–81) | 62.0 (28–84) | 61.0 (24–84) |
Male, n (%) | 123 (52.1) | 119 (49.0) | 242 (50.5) |
Female, n (%) | 113 (47.9) | 124 (51.0) | 237 (49.5) |
Race, n (%) | |||
White | 141 (59.7) | 144 (59.3) | 285 (59.5) |
Asian | 88 (37.3) | 91 (37.4) | 179 (37.4) |
Multiracial | 0 | 2 (0.8) | 2 (0.4) |
Black or African American | 0 | 1 (0.4) | 1 (0.2) |
Not reported | 7 (3.0) | 5 (2.1) | 12 (2.5) |
Body site, n (%) | |||
Colon | 191 (80.9) | 192 (79.0) | 383 (80.0) |
Rectum | 24 (10.2) | 27 (11.1) | 51 (10.6) |
Cecum | 21 (8.9) | 24 (9.9) | 45 (9.4) |
Side of tumor, n (%) | |||
Left | 89 (37.7) | 98 (40.3) | 187 (39.0) |
Right | 147 (62.3) | 145 (59.7) | 292 (61.0) |
Stage at initial diagnosis, n (%) | |||
I | 3 (1.3) | 2 (0.8) | 5 (1.0) |
II | 13 (5.5) | 10 (4.1) | 23 (4.8) |
III | 37 (15.7) | 43 (17.7) | 80 (16.7) |
IV | 183 (77.5) | 188 (77.4) | 371 (77.5) |
Primary tumor resection, n (%) | |||
Complete | 116 (49.2) | 105 (43.2) | 221 (46.1) |
Partial | 14 (5.9) | 13 (5.3) | 27 (5.6) |
None | 106 (44.9) | 125 (51.4) | 231 (48.2) |
No. of organs involved, n (%)a | |||
≤2 | 122 (51.7) | 129 (53.1) | 251 (52.4) |
≥3 | 114 (48.3) | 114 (46.9) | 228 (47.6) |
Liver metastases, n (%)a | 144 (61.0) | 156 (64.2) | 300 (62.6) |
Eastern Cooperative Oncology Group performance status, n (%) | |||
0 | 129 (54.7) | 131 (53.9) | 260 (54.3) |
1 | 103 (43.6) | 98 (40.3) | 201 (42.0) |
Missing | 4 (1.7) | 14 (5.8) | 18 (3.8) |
Central BRAF V600E status (tumor tissue), n (%) | |||
Detected | 226 (95.8) | 224 (92.2) | 450 (93.9) |
Indeterminate | 0 | 1 (0.4) | 1 (0.2) |
Not detected | 4 (1.7) | 2 (0.8) | 6 (1.3) |
Not available | 6 (2.5) | 16 (6.6) | 22 (4.6) |
Local microsatellite instability/mismatch repair deficiency status, n (%) | |||
High microsatellite instability/mismatch repair deficiency | 1 (0.4) | 0 | 1 (0.2) |
Microsatellite stable/proficient mismatch repair | 229 (97.0) | 227 (93.4) | 456 (95.2) |
Not available | 6 (2.5) | 16 (6.6) | 22 (4.6) |
Carcinoembryonic antigen at baseline, n (%) | |||
≤5 μg liter-1 | 65 (27.5) | 63 (25.9) | 128 (26.7) |
>5 μg liter-1 | 166 (70.3) | 163 (67.1) | 329 (68.7) |
Missing | 5 (2.1) | 17 (7.0) | 22 (4.6) |
C-reactive protein at baseline, n (%) | |||
≤10 mg liter-1 | 125 (53.0) | 119 (49.0) | 244 (50.9) |
>10 mg liter-1 | 105 (44.5) | 107 (44.0) | 212 (44.3) |
Missing | 6 (2.5) | 17 (7.0) | 23 (4.8) |