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Table 2 Toxicity

From: Dose escalating study of cetuximab and 5-FU/folinic acid (FA)/oxaliplatin/irinotecan (FOLFOXIRI) in first line therapy of patients with metastatic colorectal cancer

Toxicity

All DL n (%)

DL1 (n)

DL2 (n)

DL3 (n)

 

n = 20

n = 7

n = 7

n = 6

Grade

All

Gr. 3

Gr. 4

All

Gr. 3/4

All

Gr. 3/4

All

Gr. 3/4

Hematologic

      

Neutropenia

14 (70)

3 (15)

5 (25)

5

2

3

2

6

4

Thrombopenia

11 (55)

1 ( 5)

0 (0)

4

1

4

0

3

0

Anaemia

10 (50)

0 (0)

0 (0)

3

0

4

0

3

0

Gastrointestinal

      

Diarrhoea

15 (75)

5 (25)

0 (0)

6

1

4

2*

5

2*

Nausea

13 (65)

0 (0)

0 (0)

7

0

4

0

2

0

Vomiting

6 (30)

1 (5)

0 (0)

5

1

1

0

0

0

Stomatitis

14 (70)

0 (0)

0/ 0

6

0

3

0

5

0

Other Mucositis

5 (25)

0 (0)

0 (0)

1

0

1

0

3

0

Bowel Obstruction

1 (5)

0 (0)

1 (5)

0

0

0

1

0

0

General disorders

      

Fatigue

16 (80)

0 (0)

0 (0)

5

0

5

0

6

0

Skin toxicity

18 (90)

3 (15)

0 (0)

6

1

6

2

6

0

Paronychia

6 (30)

1 (5)

0 (0)

0

0

2

0

4

1

  1. *One patient fulfilling DLT criteria.