Table 3 Grade 3/4 treatment-related adverse events

From: A phase I clinical and pharmacokinetic study of capecitabine (Xeloda®) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours

 

Adverse events: Grade 3/Grade 4

Dose level

1 (n=4)

2 (n=3)

3 (n=4)

4 (n=10)

5 (n=6)

Capecitabine (mg m−2 twice daily)

700

850

1000

1000

1150

Irinotecan (mg m−2)

200

200

200

250

250

Nausea

1/0

0/0

1/0

0/1

2/0

Diarrhoea

1/0

0/0

1/0

2/0

1/2

Vomiting

1/0

0/0

0/0

0/1

2/0

Stomatitis

0/0

0/0

0/0

0/0

1/0

Asthenia

1/0

0/0

1/0

0/0

0/0

Abdominal pain

0/0

0/0

0/0

0/0

1/0

Hand–foot syndrome

0/0

0/0

1/0

0/0

0/0

Leucopenia

1/0

0/0

0/0

1/0

1/0

Lymphopenia

0/0

0/0

0/0

0/0

2/0

Neutropenia

2/0

0/0

0/0

1/1

0/1