Table 5. All grades of toxicity reported in the first 12 weeks of treatment.
|
Arms A+C (no cetuximab)
|
Arm B (cetuximab)
|
Significance* | ||||
|---|---|---|---|---|---|---|
| OxMdG | XELOX | OxMdG | XELOX | ±Cap. | ±Cet. | |
| N | 203 | 333 | 102 | 166 | ||
| N (%) | N (%) | N (%) | N (%) | |||
|---|---|---|---|---|---|---|
| Any grade 1+ | 194 (96) | 316 (95) | 100 (98) | 161 (97) | ||
| Neutropaenia | 91 (45) | 42 (13) | 46 (45) | 9 (5) | P<0.001 | |
| Nausea or vomiting | 113 (56) | 215 (65) | 56 (55) | 95 (57) | ||
| Diarrhoea | 115 (57) | 207 (62) | 75 (74) | 117 (70) | P<0.05 | |
| Skin rash | 23 (11) | 44 (13) | 87 (85) | 139 (84) | P<0.001 | |
| Hypersensitivity | ||||||
| Any | 2 (<1) | 6 (2) | 0 (0) | 4 (2) | ||
| Oxaliplatin | 1 (1) | 4 (1) | 0 (0) | 1 (<1) | ||
| Cetuximab | — | 0 (0) | 2 (1) | |||
| Not specified | 1 (1) | 2 (1) | 0 (0) | 1 (1) | ||
| Lethargy | 157 (77) | 266 (80) | 91 (89) | 144 (87) | P<0.05 | |
| Hand–foot syndrome | 33 (16) | 89 (27) | 42 (41) | 70 (42) | P<0.001 | |
| Peripheral neuropathy | 155 (76) | 230 (71) | 76 (75) | 117 (70) | ||
| Hypomagnesaemia | 6 (3) | 7 (2) | 9 (9) | 7 (4) | P<0.05 | P<0.05 |
*Fisher's exact test.
‘Cap.’=presence vs absence of capecitabine; that is, XELOX vs OxMdG.
‘Cet.’=presence vs absence of cetuximab; that is, arm B vs arms A and C.