Table 1. Patient and sample characteristics.
Clinical CAPEOXBEV | Clinical CAPEOX | Screening cohort | Screening cohort | Validation cohort | CAPEOXBEV | CAPEOX cohort | CAPEOX | |
cohort | cohort | (LDA A+B card) | (cLDA) | (cLDA) | included vs. not-included | (cLDA) | included vs. not-included | |
P | P | |||||||
Treatment start years, range | 2006–2011 | 2003–2006 | 2006–2010 | 2006–2010 | 2007–2011 | 2003–2006 | ||
Number of patients | 623 | 211 | 203 | 155 | 121 | 127 | ||
Age, median (range) | 65 (22–84) | 63 (36–85) | 65 (37–84) | 65 (40–84) | 67 (22–82) | 0.27 | 62 (36–82) | 0.24 |
Sex, female (%) | 281 (45%) | 77 (36%) | 111 (55%) | 83 (54%) | 40 (33%) | 0.75 | 45 (35%) | 0.66 |
Primary tumor location | 0.15 | 0.45 | ||||||
Cecum, ascending colon | 133 (21%) | 37 (18%) | 52 (26%) | 38 (25%) | 23 (19%) | 26 (20%) | ||
Right flexure, transverse colon | 60 (10%) | 16 (8%) | 15 (7%) | 11 (7%) | 7 (6%) | 8 (6%) | ||
Left flexure, descending colon | 33 (5%) | 12 (6%) | 9 (4%) | 6 (4%) | 7 (6%) | 9 (7%) | ||
Sigmoid colon | 192 (31%) | 62 (29%) | 70 (34%) | 56 (36%) | 38 (31%) | 37 (29%) | ||
Rectum | 205 (33%) | 84 (40%) | 57 (28%) | 44 (28%) | 46 (38%) | 47 (37%) | ||
Primary tumor resected | 319 (51%) | 157 (74%) | 186 (92%) | 148 (95%) | 84 (69%) | <0.0001 | 116 (91%) | <0.0001 |
Number of metastatic sites | 0.004 | 1.00 | ||||||
1 | 198 (32%) | 71 (34%) | 74 (36%) | 63 (41%) | 42 (35%) | 42 (33%) | ||
>1 | 425 (68%) | 140 (66%) | 129 (64%) | 92 (59%) | 79 (65%) | 85 (67%) | ||
No. of first line cycles, median (range) | 7 (1–46) | 6 (1–16)* | 7 (1–46) | 7 (1–46) | 7 (1–23) | 0.25 | 6 (1–15)* | 0.92 |
Treated with irinotecan | 357 (58%)* | 105 (64%)* | 117 (58%) | 95 (61%) | 76 (63%) | 0.05 | 64 (72%) | 0.29 |
Performance status | 0.04 | 0.32 | ||||||
0 | 260 (61%) | 81 (50%) | 93 (61%) | 75 (65%) | 60 (71%) | 48 (48%) | ||
1 | 138 (32%) | 66 (41%) | 52 (34%) | 37 (32%) | 19 (22%) | 39 (39%) | ||
≥2 | 27 (6%) | 15 (9%) | 8 (5%) | 3 (3%) | 6 (7%) | 12 (12%) | ||
Missing | 198 | 49 | 50 | 40 | 36 | 28 | ||
Prior adjuvant treatment, no. (%) | 57 (9%) | 37 (18%) | 28 (14%) | 22 (14%) | 13 (11%) | 0.008 | 26 (20%) | 0.20 |
TTP events | 130 (84%) | 98 (81%) | 115 (91%) | |||||
Median time to disease progression | 8.6 mo | 7.6 mo | 9.2 mo | 9.5 mo | 8.3 mo | 0.04 | 8.4 mo | 0.27 |
OS events | 130 (84%) | 93 (77%) | 125 (98%) | |||||
Median overall survival | 16.1 mo | 15.2 mo | 19.0 mo | 25.0 mo | 21.9 mo | <0.0001 | 16.4 mo | 0.12 |
Sample type | ||||||||
Resection | – | – | – | 146 (94%) | 83 (69%) | 115 (91%) | ||
Biopsy | – | – | – | 9 (6%) | 38 (31%) | 12 (9%) | ||
Tumor cell percentage, median (range) | – | – | – | 30 (2–70) | 30 (5–70) | 30 (5–70) | ||
cLDA mean Ct, median (1./3. quartile) | – | – | – | 19.9 (19.5/20.9) | 20.8 (20.0/22.0) | 20.7 (20.3/21.7) |
* Data were missing for some patients; ranges and percentages are based on the patients with available data.