| | |
No.patients who experienced toxicity, at maximum grade per patient, at each dose level, mg/mq/die
|
|---|
|
Toxicity
|
NCIC-CTC grade
|
1500
|
1750
|
2000
|
2250
|
2500
|
2750
|
|---|
|
Nausea/vomiting
|
0
|
2
|
3
|
2
|
2
|
5
|
4
|
| |
1
|
1
|
0
|
1
|
1
|
0
|
4
|
| |
2
|
0
|
0
|
0
|
0
|
1
|
1
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Diarrhoea
|
0
|
2
|
3
|
3
|
2
|
3
|
3
|
| |
1
|
1
|
0
|
0
|
0
|
1
|
4
|
| |
2
|
0
|
0
|
0
|
1
|
2
|
2
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Liver Toxicity
|
0
|
3
|
2
|
3
|
2
|
6
|
6
|
| |
1
|
0
|
1
|
0
|
1
|
0
|
3
|
| |
2
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stomatitis
|
0
|
3
|
3
|
2
|
2
|
5
|
6
|
| |
1
|
0
|
0
|
1
|
1
|
1
|
3
|
| |
2
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
HFS
|
0
|
3
|
2
|
3
|
2
|
4
|
4
|
| |
1
|
0
|
1
|
0
|
1
|
1
|
3
|
| |
2
|
0
|
0
|
0
|
0
|
1
|
2
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fatigue
|
0
|
2
|
2
|
1
|
0
|
3
|
2
|
| |
1
|
0
|
1
|
2
|
2
|
1
|
4
|
| |
2
|
1
|
0
|
0
|
1
|
2
|
2
|
| |
3*
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Leuco-neutropenia
|
0
|
2
|
2
|
2
|
2
|
3
|
6
|
| |
1
|
0
|
1
|
0
|
0
|
1
|
1
|
| |
2
|
1
|
0
|
1
|
1
|
0
|
1
|
| |
3
|
0
|
0
|
0
|
0
|
1
|
1
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Thrombocytopenia
|
0
|
2
|
3
|
2
|
3
|
5
|
6
|
| |
1
|
0
|
0
|
0
|
0
|
1
|
2
|
| |
2
|
1
|
0
|
1
|
0
|
0
|
1
|
| |
3
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Anemia
|
0
|
1
|
2
|
1
|
2
|
3
|
7
|
| |
1
|
0
|
1
|
1
|
1
|
3
|
1
|
| |
2
|
2
|
0
|
1
|
0
|
0
|
1
|
| |
3
|
0
|
0
|
0
|
0
|
0
|
0
|
| |
4*
|
0
|
0
|
0
|
0
|
0
|
0
|
