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Table 2 Treatment-related grade ≥ 2 adverse events

From: Dual EGFR blockade with cetuximab and erlotinib combined with anti-VEGF antibody bevacizumab in advanced solid tumors: a phase 1 dose escalation triplet combination trial

 

Dose level

1

n = 1

2

n = 2

3

n = 0

4

n = 1

5

n = 6

6

n = 4

7

n = 3

8

n = 19

Total

N = 36

 

Bevacizumab

IV q2w (mg/kg)

2.5

5

5

5

7.5

7.5

7.5

10

 
 

Cetuximab

IV weekly (mg/m2)*

100, 75

100, 75

200, 125

200, 125

200, 125

400, 250

400, 250

400, 250

 
 

Erlotinib

PO daily (mg)

50

50

50

100

100

100

150

150

 

Rash

 Grade 2

 

0

0

0

1

3

2

0

10

16 (44%)

 Grade 3

 

0

0

0

0

0

0

0

4

4 (11%)

Pruritus

 Grade 2

 

0

0

0

1

0

0

0

1

2 (6%)

 Grade 3

 

0

0

0

0

0

0

0

1

2 (6%)

Diarrhea

 Grade 2

 

0

0

0

0

0

0

0

3

3 (8%)

Fatigue

 Grade 2

 

0

0

0

0

1

0

1

0

2 (6%)

Hand-foot syndrome

 Grade 2

 

0

0

0

0

0

0

1

0

2 (6%)

Hypomagnesemia

 Grade 2

 

0

0

0

0

0

0

0

2

2 (6%)

 Grade 3–4

 

0

0

0

0

1

0

0

3

4 (11%)

Nausea/vomiting

 Grade 2

 

0

0

0

0

0

0

0

1

1 (3%)

Mucositis

 

 Grade 2

 

0

0

0

0

0

0

0

1

1 (3%)

Anorexia

 Grade 2

 

0

0

0

0

0

0

0

2

2 (6%)

Hypertension

 Grade 2

 

0

0

0

0

0

0

0

1

1 (3%)

Bleeding

 Grade 3

 

0

0

0

0

1

0

0

2

3 (8%)

Elevated AST/ALT

 Grade 3

 

0

0

0

0

0

0

0

1

1 (3%)

Anemia

 Grade 3

 

0

0

0

0

1

0

0

0

1 (3%)

Transvaginal fistula

 Grade 4

 

0

0

0

0

2

0

0

0

2 (6%)

  1. * Cetuximab dose shown as loading dose and maintenance dose