Table 1. Baseline characteristics: OxCap vs OxFU.
| Arm A | Arm B (+cetuximab) | Arm C | Total | |||||
|---|---|---|---|---|---|---|---|---|
| Regimen | OxCap | OxFU | OxCap | OxFU | OxCap | OxFU | OxCap | OxFU |
| Total N patients | 525 | 266 | 523 | 279 | 527 | 277 | 1575 | 822 |
| Sex | ||||||||
| Female | 187 (36%) | 95 (36%) | 168 (32%) | 97 (35%) | 181 (34%) | 105 (38%) | 536 (34%) | 297 (36%) |
| Age | ||||||||
| 65+ | 239 (46%) | 120 (45%) | 241 (46%) | 135 (48%) | 255 (48%) | 108 (39%) | 735 (47%) | 363 (44%) |
| Median age (IQR) | 63 (56, 69) | 63 (57, 69) | 64 (58, 70) | 64 (58, 70) | 64 (58, 70) | 62 (57, 69) | 64 (57, 70) | 63 (57, 69) |
| WHO PS | ||||||||
| 2+ | 34 (6%) | 22 (8%) | 37 (7%) | 23 (8%) | 37 (7%) | 22 (8%) | 108 (7%) | 67 (8%) |
| Current status of primary tumour | ||||||||
| Resected | 290 (55%) | 145 (55%) | 269 (51%) | 145 (52%) | 261 (50%) | 153 (55%) | 820 (52%) | 443 (54%) |
| Type of metastases | ||||||||
| Liver only | 108 (21%) | 62 (23%) | 122 (23%) | 69 (25%) | 102 (19%) | 76 (27%) | 332 (21%) | 207 (25%) |
| Liver | 389 (74%) | 205 (77%) | 389 (74%) | 215 (77%) | 389 (74%) | 214 (77%) | 1167 (74%) | 634 (77%) |
| Lung | 206 (39%) | 113 (43%) | 218 (42%) | 113 (40%) | 219 (42%) | 107 (38%) | 643 (41%) | 333 (41%) |
| Other (including nodes and peritoneum) | 329 (63%) | 149 (56%) | 301 (58%) | 164 (59%) | 325 (62%) | 151 (54%) | 955 (61%) | 464 (56%) |
| Mean number of metastatic sites | 1.93 | 1.94 | 1.88 | 1.94 | 1.95 | 1.86 | 1.92 | 1.92 |
| Site of primary tumour | ||||||||
| Colon | 287 (55%) | 153 (58%) | 284 (54%) | 152 (55%) | 272 (52%) | 160 (58%) | 843 (53%) | 465 (57%) |
| Rectum | 162 (31%) | 76 (28%) | 167 (32%) | 92 (33%) | 168 (32%) | 79 (28%) | 497 (32%) | 247 (30%) |
| Rectosigmoid junction | 75 (14%) | 36 (13%) | 72 (14%) | 34 (12%) | 86 (16%) | 38 (14%) | 233 (15%) | 108 (13%) |
| Other and missing data | 1 (<1%) | 1 (<1%) | 0 (0%) | 1 (<1%) | 1 (<1%) | 0 (0%) | 2 (<1%) | 2 (<1%) |
| CrCl groups | ||||||||
| Normal (>80 ml min−1) | 265 (50%) | 131 (49%) | 268 (51%) | 154 (55%) | 272 (52%) | 154 (56%) | 805 (51%) | 439 (53%) |
| Impaired (50–80 ml min−1) | 257 (49%) | 132 (50%) | 247 (47%) | 123 (44%) | 252 (48%) | 122 (44%) | 756 (48%) | 377 (46%) |
| Other (<50 or missing) | 3 (1%) | 3 (1%) | 8 (2%) | 2 (1%) | 3 (1%) | 1 (<1%) | 14 (1%) | 6 (1%) |
| Second-line therapy a | ||||||||
| Eligible | 477 (91%) | 239 (90%) | 452 (86%) | 240 (86%) | 436 (83%) | 206 (74%) | 1365 (87%) | 685 (83%) |
| Chemotherapy | 278 (58%) | 159 (67%) | 242 (54%) | 135 (56%) | 217 (50%) | 113 (55%) | 737 (54%) | 407 (59%) |
| Biological | 29 (6%) | 18 (8%) | 26 (6%) | 21 (9%) | 23 (5%) | 15 (7%) | 78 (6%) | 54 (8%) |
| Total dose of oxaliplatin (mg) | ||||||||
| Median (IQR) | 797 (464, 1035) | 848 (498, 1023) | 682 (397, 1016) | 806 (486, 1018) | 528 (454, 1003) | 520 (458, 966) | 652 (436, 1024) | 741 (481, 1016) |
Abbreviations: CrCl=creatinine clearance; OxCap=oxaliplatin/capecitabine; OxFU=oxaliplatin/leucovorin (LV)/infusional 5-FU; PS=performance status.
a
Patients (within the sample used throughout this analysis) were considered eligible for second-line therapy if they had come off trial and were not lost to follow-up. Loss to follow-up was defined as no data being received within 6 months of data freeze. Rates of chemotherapy and biologicals received are with respect to numbers eligible.