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Table 1 Patients characteristics

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

Characteristics

n (%)

DL1

DL2*

DL3

n

n

n

Total patient number

20 (100)

7

7

6

Gender

    

  Male

15 (75)

4

6

5

  Female

5 (25)

3

1

1

Age

    

  Median Age – years (range)

59 (34–72 )

57 (34–72)

64 (43–67)

57 (44–69)

ECOG PS

    

  ECOG PS 0

15 (75)

5

7

3

Primary tumor site

    

  Colon

10 (50)

4

5

1

  Rectum

10 (50)

3

2

5

Previous adjuvant therapy

    

  None

17 (85)

4

7

6

  5-FU (infusional)

3 (15)

3

0

0

  5-FU (bolus)

1 (5)

1

0

0

  Oxaliplatin

2 (10)

2

0

0

Number of metastatic sites

    

  Median number (range)

1.75 (1–3)

2.1 (1–3)

1.7 (1–3)

1.3 (1–2)

KRAS status (retrospective)

    

  Wild type

14 (70)

6

3

5

  Mutant

6 (30)

1

4

1

  1. *One further patient in this dose level was excluded from all analyses owing to i.v. port-catheter dysfunction during the first dose.