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Table 1 Patient demographics, disease characteristics, and prior therapy

From: TIMP-1 and responsiveness to gemcitabine in advanced breast cancer; results from a randomized phase III trial from the Danish breast cancer cooperative group

  

Included

  

Excluded

  

Characteristics

No.

 

(%)

No.

 

(%)

Pd

No. of patients

264

  

73

   

Regimen

      

0.36

   Docetaxel and Gemcitabine

137

 

(51.9)

33

 

(45.2)

 

   Docetaxel

127

 

(48.1)

40

 

(54.8)

 

Median age at randomization, years

 

59

  

57

 

0.57e

   Range

 

30-75

  

36-73

  

ECOG performance status

      

0.84

   0-1

223

 

(84.5)

65

 

(89.0)

 

   2

32

 

(12.1)

8a

 

(11.0)

 

   Unknown

9

 

(3.4)

0

 

(0.0)

 

Stage of disease

      

0.049

   Locally advanced

22

 

(8.3)

12

 

(16.4)

 

   Metastatic

242

 

(91.7)

61

 

(83.6)

 

No. of metastatic sites

      

0.74

   1

78

 

(29.5)

18

 

(24.7)

 

   2

93

 

(35.2)

27

 

(37.0)

 

   ≥ 3

93

 

(35.2)

28

 

(38.4)

 

Type of metastatic site

       

   Visceral

150

 

(56.8)

43

 

(58.9)

0.79

   Lung

78

 

(29.5)

25

 

(34.2)

 

   Liver

99

 

(37.5)

27

 

(37.0)

 

   Non-visceral

114

 

(43.2)

30

 

(41.1)

 

   Bone

175

 

(66.3)

41

 

(56.2)

 

Hormone receptor status

      

0.76

   Positive

190

 

(72.0)

49

 

(67.1)

 

   Negative

70

 

(26.5)

20

 

(27.4)

 

   Unknown

4

 

(1.5)

4

 

(5.5)

 

HER2 statusb

      

0.77

   Normal/deletion

212

 

(80.3)

20

 

(27.4)

 

   Amplification

37

 

(14.0)

4

 

(5.5)

 

   Unknown

15

 

(5.7)

49

 

(67.1)

 

PAM50 subtype

      

0.18

   Luminal A

78

 

(29.5)

6

 

(8.2)

 

   Luminal B

94

 

(35.6)

3

 

(4.1)

 

   Basal-like

40

 

(15.2)

3

 

(4.1)

 

   HER2-enriched

46

 

(17.4)

0

 

(0.0)

 

   Unknown

6

 

(2.3)

61

 

(83.6)

 

Prior chemotherapy

       

   Total

188

 

(71.2)

45

 

(61.6)

0.15

   (Neo)adjuvant

127

 

(48.1)

17

 

(23.3)

0.0002

    Anthracycline

71

 

(26.9)

11

 

(15.1)

 

    Non-anthracycline

56

 

(21.2)

6

 

(8.2)

 

   Locally advanced/metastatic

102

 

(38.6)

31

 

(42.5)

0.20

    Anthracycline

86

 

(32.6)

30

 

(41.1)

 

    Non-anthracycline

16

 

(6.1)

1

 

(1.4)

 

Hormonal therapy

       

   Total

173

 

(65.5)

41

 

(56.2)

0.17

   Adjuvant

119

 

(45.1)

19

 

(26.0)

0.006

   Locally advanced/metastatic

120

 

(45.5)

37

 

(50.7)

0.43

Radiation therapy

157

 

(59.5)

22

 

(30.1)

<0.0001

Disease-free interval, monthsc

       

   Median

 

31

  

22

 

0.12e

   Range

 

0-250

  

0-231

  
  1. aIncluding one patient ECOG performance status 3.
  2. bRetrospective analysis, primary tumor only.
  3. cTime interval from diagnosis of primary cancer to recurrence.
  4. dFisher's exact test, unknown values excluded from tests.
  5. eWilcoxon test.
  6. Abbreviations: ECOG Eastern Cooperative Oncology Group, HER2 Human epidermal growth factor receptor 2.