Table 6. Grade 3 and 4 toxicities reported over 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 3 or 4 | 72 (35) | 118 (36) | 64 (63) | 95 (58) | P<0.001 | |
| Neutropaenia | 35 (17) | 5 (2) | 27 (26) | 1 (1) | P<0.001 | |
| Neutropaenic sepsis/febrile neutropaenia | 9 (4) | 3 (1) | 5 (5) | 0 (0) | P<0.001 | |
| Nausea or vomiting | 6 (3) | 23 (7) | 7 (7) | 23 (14) | P<0.05 | P<0.05 |
| Diarrhoea | 13 (6) | 50 (15) | 13 (13) | 42 (25) | P<0.001 | P<0.05 |
| Skin rash | 0 (0) | 2 (1) | 12 (12) | 16 (10) | P<0.001 | |
| Hypersensitivity | ||||||
| Any | 0 (0) | 1 (<1) | 0 (0) | 2 (1) | ||
| Oxaliplatin | 0 (0) | 1 (<1) | 0 (0) | 0 (0) | ||
| Cetuximab | — | 0 (0) | 1 (1) | |||
| Not specified | 0 (0) | 0 (0) | 0 (0) | 1 (1) | ||
| Lethargy | 15 (7) | 27 (8) | 21 (21) | 28 (17) | P<0.001 | |
| Hand—foot syndrome | 1 (<1) | 7 (2) | 4 (4) | 7 (4) | ||
| Peripheral neuropathy | 4 (2) | 14 (4) | 0 (0) | 10 (6) | P<0.05 | |
| Hypomagnesaemia | 0 (0) | 1 (<1) | 0 (0) | 0 (0) | ||
*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.