Table 3 Incidence of clinically relevant toxicities
Dose (mg m−2) (n) | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade | ||||||||||||||||
300 (3) | 500 (3) | 600 (3) | 700 (6) | 800 (3) | 900 (4) | 1000 (3) | 1200 (6) | |||||||||
Toxicity | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 |
Hematologic | ||||||||||||||||
Erythropenia | 1 | 0 | 1 | 0 | 3 | 0 | 4 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 5 | 0 |
Hematocrit decreased | 1 | 0 | 1 | 0 | 3 | 0 | 4 | 0 | 3 | 0 | 2 | 0 | 2 | 0 | 5 | 0 |
Haemoglobin decreased | 2 | 0 | 2 | 0 | 2 | 0 | 3 | 0 | 2 | 0 | 1 | 1 | 2 | 0 | 4 | 1 |
Leucopenia | 1 | 0 | 3 | 0 | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 5 | 1 |
Lymphopenia | 0 | 0 | 2 | 1 | 0 | 1 | 3 | 0 | 1 | 0 | 1 | 1 | 3 | 0 | 4 | 1 |
Neutropenia | 1 | 0 | 1 | 2 | 1 | 2 | 3 | 2 | 0 | 2 | 1 | 1 | 2 | 0 | 2 | 1 |
Thrombocytopenia | 0 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 2 | 0 |
Nonhematologic | ||||||||||||||||
ALT elevation | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 3 | 3 | 0 | 1 | 1 | 1 | 0 | 5 | 0 |
AST elevation | 0 | 0 | 3 | 0 | 2 | 0 | 4 | 1 | 3 | 0 | 3 | 0 | 2 | 0 | 5 | 0 |
Blood bilirubin increased | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
LDH elevation | 0 | 0 | 3 | 0 | 3 | 0 | 5 | 0 | 3 | 0 | 2 | 0 | 1 | 0 | 4 | 0 |
Alopecia | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Anorexia | 0 | 0 | 1 | 0 | 3 | 0 | 5 | 0 | 3 | 0 | 0 | 1 | 3 | 0 | 4 | 0 |
Constipation | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
Diarrhoea | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 0 |
Fatigue | 1 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 2 | 0 | 3 | 0 |
Infection | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Nausea | 2 | 0 | 3 | 0 | 3 | 0 | 5 | 0 | 3 | 0 | 2 | 0 | 2 | 0 | 5 | 0 |
Malaise | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pruritus | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 |
Rash | 3 | 0 | 2 | 0 | 3 | 0 | 5 | 0 | 2 | 0 | 4 | 0 | 3 | 0 | 5 | 1 |
Vomiting | 2 | 0 | 3 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |