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 | ||||||||||||