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Table 4 Most common grade 3–4 non-haematological toxicity possibly or probably related to irinotecan combined with 5-FU/FA Mayo Clinic schedule according to dose levels (worst grade by patient)

From: Phase I/II study of first-line irinotecan combined with 5-fluorouracil and folinic acid Mayo Clinic schedule in patients with advanced colorectal cancer

Dose level

Phase I

Phase II

 

I

II

Overall

 

Irinotecan (mg/m2)

250

300

250/300

250

5-FU (mg/m2)

425

425

425

425

FA (mg/m2)

20

20

20

20

Number of patients

6

8

14

49

Delayed diarrhoea

4

4

8 (57%)

16 (33%)

Fatigue

2

3

5 (36%)

11 (22%)

Pain

3

1

4 (29%)

9 (18%)

Stomatitis

4

1

5 (36%)

13 (26%)

Alopecia

1

0

1 (7%)

2 (4%)

Nausea

2

0

2 (14%)

8 (16%)

Anorexia

1

1

2 (14%)

0

Vomiting

1

0

1 (7%)

7 (14%)

Fever

0

1

1 (7%)

0

Infection

0

0

0

8 (16%)