Table 1.
Main clinical features of the whole EORTC 05963 trial population according to the availability or not of actigraphy assessment at baseline.
| Variable | CircAct assessment available |
Total (33) |
|
|---|---|---|---|
|
Yes (n=130)* |
No (n=434) |
n=564 |
|
| |
n (%) |
n (%) |
n (%) |
| Treatment arm | |||
| FOLFOX2 | 67 (51.5) | 215 (49.5) | 282 (50) |
| ChronoFLO4 |
63 (48.5) |
219 (50.5) |
282 (50) |
| WHO PS | |||
| 0 | 70 (53.8) | 203 (46.8) | 273 (48.4) |
| 1 | 45 (34.6) | 186 (42.9) | 231 (41.0) |
| 2 |
15 (11.5) |
45 (10.4) |
60 (10.6) |
| Age (years) | |||
| Median | 60 | 63 | 62 |
| Range |
22−76 |
24−76 |
22−76 |
| Gender | |||
| Male | 74 (56.9) | 264 (60.8) | 338 (59.9) |
| Female |
56 (43.1) |
170 (39.2) |
226 (40.1) |
| Body Mass Index (kg/m2) | |||
| ≤ 18.4 (underweight) | 4 (3.1) | 19 (4.4) | 23 (4.1) |
| 18.5 − 24.9 (normal) | 57 (43.8) | 220 (50.7) | 277 (49.1) |
| 25.0 − 29.9 (overweight) | 51 (39.2) | 134 (30.9) | 185 (32.8) |
| ≥ 30.0 (obese) | 17 (13.1) | 59 (13.6) | 77 (13.7) |
| Missing | 0 | 2 (0.5) | 2 (0.4) |
| Median | 25.2 | 24.5 | 24.6 |
| Range |
16.7−39.1 |
14.9−42.9 |
14.9−42.9 |
| Site of primary tumor | |||
| Colon | 96 (73.8) | 329 (75.8) | 425 (75.4) |
| Rectum |
34 (26.2) |
105 (24.2) |
139 (24.6) |
| Number of metastatic sites | |||
| 0 | 0 ( 0.0) | 4 ( 0.9) | 4 ( 0.7) |
| 1 | 58 (44.6) | 224 (51.6) | 282 (50.0) |
| 2 | 52 (40.0) | 139 (32.0) | 191 (33.9) |
| ≥3 | 20 (15.4) | 66 (15.2) | 86 (15.2) |
| Unknown |
0 ( 0.0) |
1 ( 0.2) |
1 ( 0.2) |
| Organs involved | |||
| Liver | 106 (81.5) | 377(86.9) | 483 (85.6) |
| ≤ 25 % | 62 (47.7) | 204 (47.0) | 266 (47.2) |
| > 25% | 44 (33.8) | 173 (39.9) | 217 (38.5) |
| Lung |
47 (36.2) |
162 (37.3) |
209 (37.1) |
|
Analgesics at entry |
26 (20.0) |
56 (12.9) |
82 (14.5) |
|
Previous adjuvant treatment |
23 (17.7) |
79 (18.2) |
102 (18.1) |
| WBC (109 cells/L) | |||
| Median | 8.0 | 8.1 | 8.1 |
| Range |
3.6 − 25.5 |
3.1 − 27.6 |
3.1 − 27.6 |
| ≥ 10 |
30 (23.1) |
102 (23.5) |
132 (23.4) |
| Baseline HRQoL available | 96 (74) | 347 (80) | 443 (79) |
*
Current study population
WHO PS = Performance status (World Health Organization)
WBC = White blood cell count
HRQoL = Health-related quality of life