Table 3. Tolerability.
EOX (n=17) | OX (n=19) | X (n=19) | Total (n=55) | |
---|---|---|---|---|
Grade 3+ non-haematological toxicities (at 6-week assessment) | ||||
Any toxicity or SAR | 8 (47%) | 7 (37%) | 7 (39%) | 22 (41%) |
Nausea | 2 (12%) | 0 (0%) | 0 (0%) | 2 (4%) |
Vomiting | 1 (6%) | 1 (5%) | 0 (0%) | 2 (4%) |
Anorexia | 1 (6%) | 0 (0%) | 0 (0%) | 1 (2%) |
Stomatitis | 0 (0%) | 0 (0%) | 1 (6%) | 1 (2%) |
Diarrhoea | 2 (12%) | 0 (0%) | 2 (11%) | 4 (7%) |
Lethargy | 4 (24%) | 2 (11%) | 1 (6%) | 7 (13%) |
Peripheral neuropathy | 0 (0%) | 1 (5%) | 0 (0%) | 1 (2%) |
Hand and foot syndrome | 0 (0%) | 0 (0%) | 1 (6%) | 1 (2%) |
Other | 4 (24%) | 3 (16%) | 3 (17%) | 10 (19%) |
Treatment delay (at cycles 2 or 3) | ||||
Yes | 5 (29%) | 2 (11%) | 2 (11%) | 9 (17%) |
No | 12 (71%) | 17 (89%) | 16 (89%) | 45 (83%) |
Dose reduction (at cycles 2 or 3) | ||||
Yes | 4 (24%) | 3 (16%) | 3 (17%) | 10 (19%) |
No | 13 (76%) | 16 (84%) | 15 (83%) | 44 (81%) |
Treatment stopped at any time during trial | ||||
Yes | 13 (76%) | 16 (84%) | 14 (78%) | 43 (80%) |
No | 4 (24%) | 3 (16%) | 4 (22%) | 11 (20%) |
Dose escalation (at 6-week assessment) | ||||
Yes | 2 (12%) | 3 (16%) | 5 (28%) | 10 (19%) |
No | 15 (88%) | 16 (84%) | 13 (72%) | 44 (81%) |
Abbreviations: EOX=epirubicin, oxaliplatin and capecitabine; OX=oxaliplatin and capecitabine; SAR=serious adverse reaction; X=capecitabine.