Table 4 Percentage of patients experiencing toxicity by treatment arm according to WHO grades
5FU | 5FU-LEV | 5FU-FA | 5FU-FA-LEV | P -value | P -value | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n =269 | n =310 | n =268 | n =296 | FA effect (n =1143) | LEV effect ( n =1059) | |||||||||||||
Type of toxicity | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | all grades | all grades |
Vomiting | 15 | 4 | 0.4 | — | 17 | 7 | 0.3 | 0.6 | 17 | 8.6 | 1.9 | 0.4 | 22 | 8.4 | 1 | 0.3 | 0.004 | 0.11 |
Diarrhoea | 13 | 5.9 | 2.2 | — | 12 | 11 | 3.5 | — | 10 | 19 | 9 | 1 | 12 | 15 | 8 | 1.7 | <0.0001 | 0.56 |
Mucositis | 8.9 | 3 | 0.3 | 0.3 | 9.7 | 5.8 | 0.9 | — | 16 | 8.2 | 9.7 | 2.2 | 17 | 13 | 3.7 | 2.7 | <0.0001 | 0.24 |
Fever | — | — | — | — | — | 0.3 | 0.3 | — | 1.5 | 0.7 | 0.3 | — | 1 | 1 | 0.3 | 0.3 | 0.0017 | 0.35 |
Leukopenia | 8.6 | 6.3 | 0.7 | 0.3 | 9.4 | 6.8 | 0.9 | — | 9.3 | 5.2 | 1.9 | 0.7 | 8.8 | 5.4 | 0.3 | 1 | 0.92 | 0.77 |
Anemia | 2.6 | — | — | — | 1.9 | 1.3 | — | — | 4.5 | 1.1 | — | — | 3.7 | 0.7 | — | — | 0.09 | 0.75 |
Thrombocytopenia | 3.3 | 0.3 | — | — | 2.6 | 0.3 | 0.3 | — | 2.2 | 0.3 | 0.3 | — | 1 | — | 0.3 | — | 0.20 | 0.48 |
Skin | 3.3 | 0.3 | — | — | 3.5 | 2.3 | — | — | 6.3 | 3.7 | 1.1 | — | 6.8 | 4.4 | 1 | — | <0.0001 | 0.29 |
Congiuntivitis | — | — | — | — | 0.6 | — | — | — | 1.9 | 1.9 | — | — | 3 | 0.7 | — | — | <0.0001 | 0.77 |
Alopecia | 1.5 | 0.3 | — | — | 1.3 | 0.6 | — | — | 3.4 | 1.1 | 1.1 | — | 2.4 | 3 | 0.3 | — | 0.0007 | 0.96 |
Abdominal pain | 1.1 | — | — | — | 1.3 | 0.3 | — | — | 0.3 | 0.3 | 0.3 | — | 2 | — | — | — | 0.70 | 0.55 |
Anorexia | — | — | — | — | 0.3 | — | — | — | — | — | — | — | 0.3 | — | — | — | 0.99 | — |
Taste alteration | 0.3 | — | — | — | — | — | — | — | 0.3 | — | — | — | — | — | — | — | 0.99 | 0.51 |
Gastric ulcer | — | — | — | 0.3 | — | 0.3 | — | — | — | — | — | — | — | — | — | — | 0.49 | 0.99 |
GI tract bleeding | 0.3 | — | 0.3 | — | — | — | — | — | 0.3 | — | — | — | — | — | — | — | 0.87 | 0.26 |
Constipation | 0.3 | — | — | — | 1 | 0.3 | 0.3 | — | — | 0.7 | — | — | 0.7 | 0.7 | — | — | 0.96 | 0.11 |
Bilirubin | 1.1 | 0.3 | — | — | 0.9 | 0.3 | — | — | 0.7 | 0.3 | — | — | 1 | 0.3 | — | — | 0.96 | 0.99 |
Hypertransaminasaemia | 2.2 | 0.3 | — | — | 1.6 | 0.3 | 0.3 | — | 1.1 | — | — | — | 1.4 | 0.3 | — | — | 0.22 | 0.75 |
Headhache | — | — | — | — | — | — | — | — | — | — | — | — | 0.6 | — | — | — | 0.25 | 0.49 |
Fatigue | 0.7 | — | — | — | 0.6 | — | — | — | 2.6 | — | — | — | 1.4 | 0.3 | — | — | 0.04 | 0.85 |
Cardiac | 1.1 | — | — | 1.1 | 0.6 | — | — | 0.3 | 0.3 | 0.3 | — | 0.7 | — | 0.3 | — | 0.3 | 0.57 | 0.23 |
Neurotoxicity | — | — | — | — | 0.3 | 0.3 | — | 0.3 | 0.3 | — | — | 1.1 | 0.7 | — | — | 0.7 | 0.10 | 0.48 |
Cistitis | — | — | 0.3 | — | 0.3 | 0.3 | — | — | 0.3 | — | — | — | 0.7 | — | — | — | 0.99 | 0.95 |
Renal | 0.3 | — | — | — | 0.6 | — | — | — | 0.3 | — | — | — | 0.7 | — | — | — | 0.99 | 0.97 |
Vascular | — | 0.3 | — | — | — | 0.3 | 0.3 | — | — | 0.3 | — | — | — | — | — | — | 0.57 | 0.99 |
Allergy | — | — | — | — | 0.3 | — | — | — | — | — | — | — | 0.7 | — | — | — | 0.61 | 0.24 |
Other | — | — | — | — | 0.6 | — | — | — | 0.3 | 0.3 | — | — | 1.4 | — | — | — | 0.14 | 0.43 |
Toxic death | 4 (1.5 %) | 1 (0.3 %) | 5 (1.9 %) | 3 (1.0 %) | 0.42 | 0.26 | ||||||||||||
