TABLE 1.
Patient, tumor, and treatment characteristics1
| Patients with BMI measures | Patients with SMI measures | |||
|---|---|---|---|---|
| At randomization, start p1 (n = 533) | At PD1, start p2 (n = 340) | At randomization, start p1 (n = 95) | At PD1, start p2 (n = 79) | |
| Age, mean in years (SD) | 65.8 (8.1) | 63.3 (8.8) | 65.7 (8.2) | 64.4 (8.1) |
| ≤70 | 405 (76%) | 250 (74%) | 60 (63%) | 51 (65%) |
| >70 | 128 (24%) | 90 (27%) | 35 (37%) | 28 (35%) |
| Sex | ||||
| Female | 189 (36%) | 103 (32%) | 36 (38%) | 29 (37%) |
| Male | 344 (65%) | 231 (68%) | 59 (62%) | 50 (63%) |
| Primary site | ||||
| Colon only | 266 (50%) | 170 (50%) | 49 (52%) | 40 (51%) |
| Rectum only | 153 (29%) | 96 (28%) | 25 (26%) | 20 (25%) |
| Rectosigmoid | 114 (21%) | 74 (22%) | 21 (22%) | 19 (24%) |
| Resection primary tumor | ||||
| Yes | 314 (59%) | 210 (62%) | 55 (58%) | 42 (53%) |
| No | 219 (41%) | 130 (38%) | 40 (42%) | 37 (47%) |
| WHO performance status | ||||
| 0 | 334 (63%) | Only available at randomization | 60 (63%) | Only available at randomization |
| 1 | 199 (37%) | — | 35 (37%) | — |
| Number of metastatic sites | ||||
| 1 | 218 (43%) | Only available at randomization | 34 (36%) | Only available at randomization |
| >1 | 291 (57%) | — | 55 (58%) | — |
| Missing | 24 | — | 10 | — |
| Lactate dehydrogenase, IU/L | ||||
| Elevated | 298 (56%) | Only available at randomization | 57 (60%) | Only available at randomization |
| Normal | 235 (44%) | — | 38 (40%) | — |
| BMI, mean (SD), kg/m2 | 27.0 (4.3) | 26.6 (4.0) | 26.5 (4.9) | 26.9 (4.4) |
| Underweight (<18.5) | 3 (1%) | 4 (1%) | 1 (1%) | 1 (2%) |
| Normal weight (18.5–25) | 165 (31%) | 109 (32%) | 43 (46%) | 14 (30%) |
| Overweight (25–30) | 253 (48%) | 172 (51%) | 32 (34%) | 23 (49%) |
| Obese (30+) | 112 (21%) | 55 (16%) | 17 (18%) | 9 (19%) |
| Unknown | 0 | 0 | 2 | 32 |
| SMI, mean (SD) | ||||
| Males | NA2 | NA2 | 48.2 (7.2) | 48.9 (8.3) |
| Females | NA2 | NA2 | 41.0 (6.0) | 40.9 (5.0) |
| Sarcopenia3 | ||||
| Males | NA2 | NA2 | 25 (42%) | 13 (34%) |
| Females | NA2 | NA2 | 16 (44%) | 9 (31%) |
| Best response to initial CAPOX-B treatment | ||||
| Complete or partial response | 350 (66%) | 222 (65%) | 71 (75%) | 59 (75%) |
| Stable disease | 183 (34%) | 118 (35%) | 24 (25%) | 20 (25%) |
| Treatment arm | ||||
| Maintenance CAP-B | 273 (51%) | 129 (38%) | 50 (53%) | 39 (49%) |
| Observation | 260 (49%) | 211 (62%) | 45 (47%) | 40 (51%) |
| Reintroduction treatment | ||||
| CAPOX-B | 293 (55%) | 289 (85%) | 43 (45%) | 41 (52%) |
| Other | 240 (45%) | 51 (15%) | 52 (55%) | 38 (48%) |
1
Data are shown at start of 2 treatment periods for the BMI and the SMI groups. Data are shown as n(%) unless otherwise noted. CAP-B, capecitabine + bevacizumab; CAPOX-B; capecitabine + oxaliplatin + bevacizumab; NA, not applicable; PD1, first disease progression; PD2, second disease progression; p1, period 1; p2, period 2; SMI, skeletal muscle index.
2
Was only determined in the group of patients with available computed tomography scans.
3
Sarcopenia was defined as SMIs of <43 cm2/m2 for males with a BMI <25 cm2/m2, <53 cm2/m2 for males with a BMI ≥25 cm2/m2, and <41 cm2/m2 for females (9).