Table 4. G3+ toxicity: normal renal function vs mild renal impairment.
| Arms A+C (no cetuximab) | Arm B (+cetuximab) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
OxCap
|
OxFU
|
OxCap
|
OxFU
|
|||||||||
| CrCl (ml min−1) | >80 | 50–80 | >80 | 50–80 | >80 | 50–80 | >80 | 50–80 | ||||
| G3+ toxicity | N (%) | N (%) | P -value | N (%) | N (%) | P -value | N (%) | N (%) | P -value | N (%) | N (%) | P -value |
| Any toxicity | 275 (52%) | 298 (60%) | 0.047 | 162 (58%) | 169 (67%) | 0.060 | 197 (75%) | 175 (72%) | 0.16 | 120 (78%) | 99 (82%) | 0.72 |
| Nausea | 26 (5%) | 53 (11%) | 0.001 | 8 (3%) | 17 (7%) | 0.062 | 18 (7%) | 24 (10%) | 0.18 | 10 (6%) | 6 (5%) | 0.65 |
| Vomiting | 24 (5%) | 32 (6%) | 0.13 | 10 (4%) | 10 (4%) | 0.83 | 18 (7%) | 16 (7%) | 0.65 | 9 (6%) | 8 (7%) | 0.19 |
| Diarrhoea | 58 (11%) | 95 (19%) | 0.012 | 21 (7%) | 28 (11%) | 0.22 | 59 (22%) | 69 (28%) | 0.43 | 23 (15%) | 23 (19%) | 0.54 |
| Mucositis | 7 (1%) | 3 (1%) | 0.093 | 7 (2%) | 11 (4%) | 0.31 | 6 (2%) | 8 (3%) | 0.51 | 12 (8%) | 11 (9%) | 0.70 |
| Lethargy | 91 (17%) | 106 (21%) | 0.54 | 38 (14%) | 45 (18%) | 0.28 | 45 (17%) | 71 (29%) | 0.013 | 39 (25%) | 37 (31%) | 0.19 |
| PPE | 21 (4%) | 18 (4%) | 0.57 | 3 (1%) | 0 (0%) | NA | 33 (13%) | 29 (12%) | 0.61 | 9 (6%) | 7 (6%) | 0.60 |
| Neuropathy | 52 (10%) | 51 (10%) | 0.85 | 31 (11%) | 35 (14%) | 0.94 | 36 (14%) | 28 (11%) | 0.36 | 20 (13%) | 16 (13%) | 0.40 |
| Thrombocytopenia | 6 (1%) | 18 (4%) | 0.009 | 6 (2%) | 6 (2%) | 0.94 | 9 (3%) | 7 (3%) | 0.73 | 1 (1%) | 4 (3%) | 0.47 |
| Neutropenia | 14 (3%) | 14 (3%) | 0.85 | 61 (22%) | 76 (30%) | 0.085 | 5 (2%) | 5 (2%) | 0.49 | 36 (23%) | 44 (36%) | 0.045 |
| Treatment-related infection | 4 (1%) | 5 (1%) | 0.25 | 28 (10%) | 24 (9%) | 0.83 | 2 (1%) | 2 (1%) | 0.84 | 10 (6%) | 14 (12%) | 0.13 |
| Treatment-related death | 4 (1%) | 10 (2%) | 0.098 | 5 (2%) | 3 (1%) | 0.52 | 4 (2%) | 4 (2%) | 0.83 | 1 (1%) | 0 (0%) | NA |
| Outcomes in first 12 weeks | ||||||||||||
| Oxaliplatin dose reduction | 108 (20%) | 138 (28%) | 0.33 | 63 (22%) | 59 (23%) | 0.86 | 93 (35%) | 107 (44%) | 0.49 | 40 (26%) | 47 (39%) | 0.043 |
| Fp dose reduction | 183 (35%) | 226 (46%) | 0.093 | 78 (28%) | 83 (33%) | 0.31 | 139 (53%) | 163 (67%) | 0.031 | 60 (39%) | 68 (56%) | 0.018 |
| Dose delay | 203 (38%) | 241 (49%) | 0.017 | 163 (58%) | 169 (67%) | 0.11 | 123 (47%) | 128 (52%) | 0.18 | 101 (66%) | 92 (76%) | 0.031 |
Abbreviations: CrCl=creatinine clearance; fp=fluoropyrimidine; OxCap=oxaliplatin/capecitabine; OxFU=oxaliplatin/leucovorin (LV)/infusional 5-FU; NA=not applicable; PPE=palmar-plantar erythema.