Table 1.
Main clinical features of the eligible study population, separately according to sex and to randomized treatment modality as defined by timing of irinotecan peak delivery rate
| Males | Modality | |||||||
|---|---|---|---|---|---|---|---|---|
|
All N = 130 |
01:00 n = 22 |
05:00 n = 19 |
09:00 n = 18 |
13:00 n = 24 |
17:00 n = 23 |
21:00 n = 24 |
P‐value | |
| Age, (y) | ||||||||
| Median (range) | 62 (33‐80) | 64 (51‐76) | 62 (46‐80) | 60 (45‐70) | 62.5 (33‐77) | 62 (50‐79) | 61.5 (38‐71) | .492 |
| PS (WHO) | ||||||||
| 0 | 97 (74.6%) | 14 (63.6%) | 16 (84.2%) | 14 (77.8%) | 15 (62.5%) | 20 (87.0%) | 18 (75.0%) | |
| 1 | 29 (22.3%) | 7 (31.8%) | 3 (15.8%) | 3 (16.7%) | 8 (33.3%) | 2 (8.7%) | 6 (25.0%) | |
| 2 | 4 (3.1%) | 1 (4.5%) | 0 | 1 (5.6%) | 1 (4.2%) | 1 (4.3% | 0 | .441 |
| Site of primary tumor | ||||||||
| Colon | 104 (80.0%) | 17 (77.3%) | 17 (89.5%) | 16 (88.9%) | 19 (79.2%) | 16 (69.6%) | 19 (79.2%) | |
| Rectum | 26 (20.0%) | 5 (22.7%) | 2 (10.5%) | 2 (11.1%) | 5 (20.8%) | 7 (30.4%) | 5 (20.8%) | .691 |
| Prior chemotherapy | ||||||||
| No | 97 (74.6%) | 18 (81.8%) | 13 (68.4%) | 14 (77.8%) | 17 (70.8%) | 18 (78.3%) | 17 (70.8%) | .906 |
| N of sites involved | ||||||||
| 1 | 66 (50.8%) | 8 (36.4%) | 15 (78.9%) | 8 (44.4%) | 12 (50.0%) | 11 (47.8%) | 12 (50.0%) | |
| 2 | 43 (33.1%) | 7 (31.8%) | 2 (10.5%) | 9 (50.0%) | 7 (29.2%) | 9 (39.1%) | 9 (37.5%) | |
| 3 or more | 21 (16.2%) | 7 (31.8%) | 2 (10.5%) | 1 (5.6%) | 5 (20.8%) | 3 (13.0%) | 3 (12.5%) | .168 |
| Sites involved | ||||||||
| Liver only | 49 (37.7%) | 8 (36.4%) | 13 (68.4%) | 4 (22.2%) | 7 (29.2%) | 7 (30.4%) | 10 (41.7%) | |
| Liver + other | 59 (45.4%) | 12 (54.5%) | 3 (15.8%) | 10 (55.6%) | 11 (45.8%) | 12 (52.2%) | 11 (45.8%) | |
| Other only | 22 (16.9%) | 2 (9.1%) | 3 (15.8%) | 4 (22.2%) | 6 (25.0%) | 4 (17.4%) | 3 (12.5%) | .173 |
| Females | Modality | |||||||
|---|---|---|---|---|---|---|---|---|
|
All N = 63 |
01:00 n = 10 |
05:00 n = 15 |
09:00 n = 14 |
13:00 n = 9 |
17:00 n = 8 |
21:00 n = 7 |
P‐value | |
| Age, years | ||||||||
| Median (range) | 58 (29‐77) | 58.5 (35‐77) | 59 (31‐70) | 56 (49‐76) | 58 (34‐70) | 51.5 (42‐74) | 54 (29‐70) | .741 |
| PS (WHO) | ||||||||
| 0 | 45 (71.4%) | 9 (90.0%) | 9 (60.0%) | 9 (64.3%) | 7 (77.8%) | 6 (75.0%) | 5 (71.4%) | |
| 1 | 15 (23.8%) | 1 (10.0%) | 5 (33.3%) | 5 (35.7%) | 1 (11.1%) | 1 (12.5%) | 2 (28.6%) | |
| 2 | 3 (4.8%) | 0 | 1 (6.7%) | 0 | 1 (11.1%) | 1 (12.5%) | 0 | .666 |
| Site of primary tumor | ||||||||
| Colon | 49 (77.8%) | 8 (80.0%) | 11 (73.3%) | 12 (85.7%) | 6 (66.7%) | 6 (75.0%) | 6 (85.7%) | |
| Rectum | 14 (22.2%) | 2 (20.0%) | 4 (26.7%) | 2 (14.3%) | 3 (33.3%) | 2 (25.0%) | 1 (14.3%) | .642 |
| Prior chemotherapy | ||||||||
| No | 52 (82.5%) | 8 (80.0%) | 13 (86.7%) | 11 (78.6%) | 7 (77.8%) | 7 (87.5%) | 6 (85.7%) | .988 |
| N of sites involved | ||||||||
| 1 | 27 (42.9%) | 3 (30.0%) | 3 (20.0%) | 6 (42.9%) | 6 (66.7%) | 4 (50.0%) | 5 (71.4%) | |
| 2 | 20 (31.7%) | 4 (40.0%) | 5 (33.3%) | 6 (42.9%) | 0 | 3 (37.5%) | 2 (28.6%) | |
| 3 or more | 16 (25.4%) | 3 (30.0%) | 7 (46.7%) | 2 (14.3%) | 3 (33.3%) | 1 (12.5%) | 0 | .117 |
| Sites involved | ||||||||
| Liver only | 19 (30.2%) | 3 (30.0%) | 1 (6.7%) | 3 (21.4%) | 5 (55.6%) | 4 (50.0%) | 3 (42.9%) | |
| Liver + other | 29 (46.0%) | 6 (60.0%) | 10 (66.7%) | 6 (42.9%) | 2 (22.2%) | 3 (37.5%) | 2 (28.6%) | |
| Other only | 15 (23.8%) | 1 (10.0%) | 4 (26.7%) | 5 (35.7%) | 2 (22.2%) | 1 (12.5%) | 2 (28.6%) | .245 |