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Table 1 Baseline patient characteristics, n = 233

From: Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?

Characteristic

 

Number

%

Median (range)

Gender

Male

124

53

 

Age

Median (range)

57 (21-88)

  

Performance status

ECOG 0

105

45

 
 

ECOG 1

122

52

 
 

ECOG 2

6

3

 

No. of prior treatments

   

2 (0-14)

 

0-2

135

58

 
 

≥ 3

98

42

 

Primary tumor site

Gastrointestinal

108

46

 
 

Thoracic, Head & Neck

58

25

 
 

Breast & Gynecological

40

17

 
 

Urologic: Sarcoma: Other

9: 5: 13

4:2:6

 

Type of trial

Targeted agent alone

89

38.2

 
 

Cytotoxic agent alone

8

3.4

 
 

Combined

136

58.4

 

No. of metastatic sites

   

3 (1-4)

 

Locoregional disease*

20

9

 
 

1-2 sites

138

59

 
 

> 2 sites

75

32

 

Site of metastasis

Liver

121

52

 
 

Lung

129

55

 
 

Bone

39

17

 

Baseline albumin

   

41 g/L (28-48 g/L)

 

< 35 g/L

8

3

 
 

≥ 35 g/L

225

97

 

Baseline LDH

   

224 U/L (93-3132 U/L)

 

Normal LDH

142

61

 
 

Elevated LDH > ULN

91

39

 

Baseline hemoglobin

   

12.5 g/dL (8.2-17.1 g/dL)

 

< 12 g/dL

90

39

 
 

≥ 12 g/dL

143

61

 

Baseline WBC

   

7 × 109/L (2.3-20.7 × 109/L)

 

≤ 10.5 × 109/L

203

87

 
 

> 10.5 × 109/L

30

13

 

Baseline platelets

   

264 × 109/L (106-832 × 109/L)

 

≤ 400 × 109/L

204

88

 
 

> 400 × 109/L

29

12

 
  1. *Patients with locoregional disease were included as ≤ 2 metastatic sites in the analysis
  2. Abbreviations: No. = number; LDH = lactate dehydrogenase; WBC = white blood cells; ULN = upper limit of normal