Table 3 G3+ toxicity: OxCap vs OxFU
Arms A and C | Arm A | Arm B (+cetuximab) | Arm C | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
OxCap | OxFU | OxCap | OxFU | OxCap | OxFU | OxCap | OxFU | |||||
G3+ toxicity | N (%) | N (%) | P -value | N (%) | N (%) | P -value | N (%) | N (%) | P -value | N (%) | N (%) | P -value |
Any toxicity | 601 (57%) | 349 (64%) | 0.008 | 305 (58%) | 187 (70%) | 0.002 | 383 (73%) | 225 (81%) | 0.031 | 296 (56%) | 162 (58%) | 0.53 |
Nausea | 87 (8%) | 27 (5%) | 0.013 | 36 (7%) | 13 (5%) | 0.17 | 46 (9%) | 16 (6%) | 0.11 | 51 (10%) | 14 (5%) | 0.032 |
Vomiting | 61 (6%) | 24 (4%) | 0.23 | 27 (5%) | 10 (4%) | 0.32 | 36 (7%) | 18 (6%) | 0.70 | 34 (6%) | 14 (5%) | 0.52 |
Diarrhoea | 165 (16%) | 55 (10%) | 0.003 | 80 (15%) | 27 (10%) | 0.034 | 135 (26%) | 50 (18%) | 0.007 | 85 (16%) | 28 (10%) | 0.033 |
Mucositis | 11 (1%) | 22 (4%) | <0.001 | 5 (1%) | 11 (4%) | 0.008 | 16 (3%) | 25 (9%) | 0.001 | 6 (1%) | 11 (4%) | 0.016 |
Lethargy | 212 (20%) | 95 (18%) | 0.18 | 94 (18%) | 50 (19%) | 0.90 | 120 (23%) | 78 (28%) | 0.16 | 118 (22%) | 45 (16%) | 0.042 |
PPE | 41 (4%) | 3 (1%) | 0.001 | 25 (5%) | 3 (1%) | 0.016 | 65 (12%) | 17 (6%) | 0.007 | 16 (3%) | 0 (0%) | 0.002 |
Neuropathy | 107 (10%) | 72 (13%) | 0.049 | 83 (16%) | 59 (22%) | 0.031 | 67 (13%) | 36 (13%) | 0.92 | 24 (5%) | 13 (5%) | 0.98 |
Thrombocytopenia | 25 (2%) | 12 (2%) | 0.84 | 15 (3%) | 7 (3%) | 0.82 | 16 (3%) | 7 (3%) | 0.65 | 10 (2%) | 5 (2%) | 0.97 |
Neutropenia | 32 (3%) | 152 (28%) | <0.001 | 15 (3%) | 84 (32%) | <0.001 | 10 (2%) | 87 (31%) | <0.001 | 17 (3%) | 68 (25%) | <0.001 |
Treatment-related infection | 10 (1%) | 52 (10%) | <0.001 | 6 (1%) | 22 (8%) | <0.001 | 4 (1%) | 24 (9%) | <0.001 | 4 (1%) | 30 (11%) | <0.001 |
Treatment-related death | 14 (1%) | 8 (1%) | 0.86 | 5 (1%) | 5 (2%) | 0.29 | 9 (2%) | 1 (<1%) | 0.13 | 9 (2%) | 3 (1%) | 0.53 |
Outcomes in first 12 weeks | Arms A and C | Arm A | Arm B (+cetuximab) | Arm C | ||||||||
Oxaliplatin dose reduction | 267 (25%) | 128 (24%) | 0.45 | 138 (26%) | 71 (27%) | 0.93 | 208 (40%) | 89 (32%) | 0.018 | 129 (24%) | 57 (21%) | 0.27 |
Fp dose reduction | 429 (41%) | 168 (31%) | <0.001 | 220 (42%) | 88 (33%) | 0.009 | 315 (60%) | 131 (47%) | <0.001 | 209 (40%) | 80 (29%) | 0.004 |
Dose delay | 466 (44%) | 338 (62%) | <0.001 | 236 (45%) | 171 (64%) | <0.001 | 261 (50%) | 197 (71%) | <0.001 | 230 (44%) | 167 (60%) | <0.001 |
