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Table 2 Associations between maximal percent changes in biomarker concentrations or baseline biomarker concentrations and efficacy endpoints

From: Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib

Biomarker

Median value (range)

Endpoint

< Median value

≥ Median value

HR* (95% CI)

p

n

Median time to event, weeks

n

Median time to event, weeks

Median maximal percent change in biomarker concentration from C1D1 to C2D28

sKIT

48.6% (−)

TTP

30

7.9

31

21.7

5.99 (3.06-11.7)

< 0.0001

  

OS

 

25.7

 

53.7

2.33 (1.16-4.70)

0.018

VEGF-A

89.4% (−)

TTP

30

9.9

31

10.3

1.75 (0.99-3.09)

0.054

  

OS

 

32.3

 

62.6

2.12 (1.06-4.23)

0.032

sVEGFR-2

55.8% (−)

TTP

30

10.1

31

10.2

1.07 (0.62-1.85)

0.81

  

OS

 

36.0

 

53.7

1.52 (0.76-3.02)

0.24

sVEGFR-3

52.8% (−)

TTP

27

10.1

28

11.0

1.40 (0.77-2.52)

0.27

  

OS

 

51.6

 

52.7

1.98 (0.79-4.96)

0.15

Median baseline biomarker concentration

sKIT

70 ng/mL (26–113)

TTP

28

10.6

28

10.1

1.08 (0.60-1.96)

0.80

  

OS

 

37.4

 

45.1

1.13 (0.55-2.35)

0.74

VEGF-A

53 pg/mL (14–709)

TTP

25

10.1

26

10.2

0.71 (0.38-1.33)

0.29

  

OS

 

Not reached

 

33.0

0.55 (0.25-1.22)

0.14

sVEGFR-2

11 ng/mL (4–15)

TTP

28

10.3

28

10.1

0.98 (0.54-1.76)

0.94

  

OS

 

37.4

 

62.6

1.19 (0.57-2.46)

0.65

sVEGFR-3

68 ng/mL (25–152)

TTP

28

10.1

28

10.2

0.97 (0.54-1.75)

0.93

  

OS

 

37.4

 

53.7

1.43 (0.68-2.98)

0.35

  1. C, cycle; CI, confidence interval; D, day; HR, hazard ratio; OS, overall survival; sKIT, soluble KIT; sVEGFR, soluble vascular endothelial growth factor receptor; TTP, time to tumor progression; VEGF, vascular endothelial growth factor.
  2. *HR > 1 favors the groups with values ≥ median value.