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Table 1 Patient and tumour characteristics according to Ki67 visual assessment (VA) and digital image analysis (DIA) of full face tissue sections

From: Visual and digital assessment of Ki-67 in breast cancer tissue - a comparison of methods

Total study population

VA categories 100 cells (median 22.3%)

VA Categories 500 cells (Median 22.3%)

DIA Categories 100 cells (Median 30%)

DIA Categories 500 cells (Median 30%)

< 12.3

> 12.3-< 32.3

> 32.3

χ2

≤ 12.3

> 12.3- < 32.3

≥ 32.3

χ2

≤ 20

> 20-< 40

≥ 40

χ2

≤ 20

> 20-< 40

≥ 40

χ2

N (%)

248

48

123

77

 

44

132

72

 

44

104

100

 

75

94

79

 

Mean age at diagnosis range (42–95) (SD)

69.9

(10.9)

69.7

(11.0)

69.8

(11.5)

70.2

(9.9)

 

71.7

(11.3)

69.0

(10.9)

70.6

(10.5)

 

71.0

(10.5)

69.4

(11.2)

69.9

(10.8)

 

70.5

(11.0)

69.4

(11.2)

70.0

(10.5)

 

Mean follow-up, years (SD)

10.9 (9.6)

12.3

(10.3)

11.3

(9.6)

9.4

(9.1)

 

12.6

(10.4)

11.4

(9.5)

8.9

(9.1)

 

11.7

(9.4)

11.5

(10.1)

9.9

(9.1)

 

11.0

(10.0)

12.1

(9.5)

9.4

(9.3)

 

Deaths from breast cancer (%)

108 (43.6)

19

(39.6)

46

(37.4)

43

(55.8)

< 0.001

17

(38.6)

49

(37.1)

42

(58.3)

< 0.001

15

(34.1)

39

(37.5)

54

(54.0)

< 0.001

28

(37.3)

38

(40.4)

42

(53.2)

< 0.001

Deaths from other causes (%)

124 (50)

25

(52.1)

69

(56.1)

30

(39.0)

 

22

(50.0)

75

(56.8)

27

(37.5)

 

25

(56.8)

57

(54.8)

42

(42.0)

 

41

(54.7)

49

(52.1)

34

(43.0)

 

Histologic grade (%)

I

16

(6.5)

6

(12.5)

10

(8.1)

0

< 0.001

6

(13.6)

10

(7.6)

0

< 0.001

5

(11.4)

11

(10.6))

0

< 0.001

9

(12.0)

7

(7.5)

0

< 0.001

II

131

(52.8)

38

(79.2)

72

(58.5)

21

(27.3)

 

34

(77.3)

84

(63.6)

13

(18.1)

 

34

(77.3)

67

(64.4)

30

(30.0)

 

54

(72.0)

56

(59.6)

21

(26.6)

 

III

101

(40.7)

4

(8.3)

41

(33.3)

56

(72.7)

 

4

(9.1)

38

(28.8)

59

(82)

 

5

(11.4)

26

(25.0)

70

(70.0)

 

12

(16.0)

31

(33.0)

58

(73.4)

 

Lymph node metastasis (%)

Yes

96 (38.7)

18

(37.5)

44

(35.8)

34

(44.2)

0.274

17

(38.6)

47

(35.6)

32

(44.4)

0.536

18

(41.0)

35

(33.7)

43

(43.0)

0.630

28

(37.3)

31

(33.0)

37

(46.8)

0.135

No

96 (38.7)

19

(39.6)

53

(43.1)

24

(31.2)

 

18

(40.9)

53

(40.2)

25

(34.7)

 

18

(41.0)

41

(33.7)

37

(37.0)

 

29

(38.7)

42

(44.7)

25

(31.7)

 

Unknown histology

56 (22.6)

11

(22.9)

26

(21.1)

19

(24.7)

 

9

(20.5)

32

(24.2)

15

(20.8)

 

8

(18.2)

28

(27.0)

20

(20.0)

 

18

(24.0)

21

(22.3)

17

(21.5)

 

Tumor size (%)

≤ 2 cm

113 (45.6)

19

(39.6)

65

(52.9)

29

(37.7)

0.317

17

(38.6)

70

(53.0)

26

(36.1)

0.162

21

(47.7)

52

(50.0)

40

(40.0)

0.863

33

(44.0)

48

(51.1)

32

(40.5)

0.562

> 2-≤ 5 cm

34 (13.7)

6

(12.5)

15

(12.2)

13

(16.9)

 

5

(11.4)

14

(10.6)

15

(20.8)

 

6

(13.6)

12

(11.5)

16

(16.0)

 

8

(10.7)

15

(16.0)

11

(13.9)

 

Uncertain, but > 2 cm

30 (12.1)

5

(10.4)

15

(12.2)

10

(13.0)

 

7

(15.9)

13

(9.9)

10

(12.1)

 

5

(11.4)

11

(10.6)

14

(14.0)

 

9

(12.0)

11

(11.7)

10

(12.7)

 

Uncertain

71 (28.6)

18

(37.5)

28

(22.8)

25

(32.5)

 

15

(34.1)

35

(26.5)

21

(29.2)

 

12

(27.3)

29

(27.9)

30

(30.0)

 

25

(33.3)

20

(21.3)

26

(32.9)

 

Stage (%)

I

114 (46.0)

19

(39.6)

66

(53.7)

29

(37.7)

0.061

18

(40.9)

69

(52.3)

27

(37.5)

0.288

20

(45.5)

52

(50.0)

42

(42.0)

0.599

33

(44.0)

51

(54.3)

30

(38.0)

0.071

II

101 (40.7)

20

(41.7)

46

(37.4)

35

(45.5)

 

20

(45.5)

48

(36.4)

33

(45.8)

 

20

(45.5)

39

(37.5)

42

(42.0)

 

32

(42.7)

35

(37.2)

34

(43.0)

 

III

17

(6.9)

4

(8.3)

8

(6.5)

5

(6.5)

 

4

(9.1)

8

(6.1)

5

(6.9)

 

2

(4.6)

7

(6.7)

8

(8.0)

 

7

(9.3)

2

(2.1)

8

(10.1)

 

IV

13

(5.2)

4

(8.3)

1

(0.8)

8

(10.4)

 

1

(2.3)

5

(3.8)

7

(9.7)

 

1

(2.3)

4

(3.9)

8

(8.0)

 

1

(1.3)

5

(5.3)

7

(8.9)

 

Unknown

3

(1.2)

1

(2.1)

2

(1.6)

0

 

1

(2.3)

2

(1.5)

0

 

1

(2.3)

2

(1.9)

0

 

2

(2.7)

1

(1.1)

0

 

Molecular subtype (%)

Luminal A

110 (44.4)

36

(75.0)

63

(51.2)

11

(14.3)

< 0.001

36

(81.8)

68

(51.5)

6

(8.3)

< 0.001

36

(81.8)

55

(52.9)

19

(19.0)

< 0.001

60

(80.0)

41

(43.6)

9

(11.4)

< 0.001

Luminal B (HER2-)

82 (33.1)

6

(12.5)

40

(32.5)

36

(46.8)

 

3

(6.8)

45

(34.1)

34

(47.2)

 

2

(4.6)

29

(27.9)

51

(51.0)

 

4

(5.3)

37

(39.4)

41

(51.9)

 

Luminal B (HER2+)

28 (11.3)

5

(10.4)

11

(8.9)

12

(15.6)

 

2

(4.6)

14

(10.6)

12

(16.7)

 

4

(9.1)

11

(10.6)

13

(13.0)

 

6

(8.0)

9

(9.6)

13

(16.5)

 

HER2 type

12

(4.8)

0

5

(4.1)

7

(9.1)

 

0

3

(2.3)

9

(12.5)

 

0

6

(5.8)

6

(6.0)

 

1

(1.3)

5

(5.3)

6

(7.6)

 

TN

16

(6.4)

1

(2.1)

4

(3.2)

11

(14.3)

 

3

(6.9)

2

(1.5)

11

(15.3)

 

2

(4.6)

3

(3.0)

11

(11.0)

 

4

(5.4)

2

(2.2)

10

(12.6)

 

Ki67 TMA high/low (%)

Ki67 < 15%

125 (50.4)

41

(85.4)

70

(56.9)

14

(18.2)

< 0.001

41

(93.2)

75

(56.8)

9

(12.5)

< 0.001

42

(95.5)

62

(59.6)

21

(21.0)

< 0.001

69

(92.0)

45

(47.9)

11

(13.9)

< 0.001

Ki67 ≥ 15%

123 (49.6)

7

(14.6)

53

(43.1)

63

(81.8)

 

3

(6.8)

57

(43.2)

63

(87.5)

 

2

(4.6)

42

(40.4)

79

(79.0)

 

6

(8.0)

49

(52.1)

68

(86.1)

 

Mitoses/10 HPF median (IQR p25, p75)

p25 = 3

p50 = 8

p75 = 14.5

Mitoses/10 HPF quartiles (%)

≤ 3

72

(29.0)

33

(68.8)

35

(28.5)

4

(5.2)

< 0.001

29

(65.9)

41

(31.1)

2

(2.8)

< 0.001

26

(59.1)

36

(34.6)

10

(10.0)

< 0.001

44

(57.9)

21

(22.6)

7

(8.9)

< 0.001

> 3-≤8

67

(27.0)

9

(18.8)

49

(39.8)

9

(11.7)

 

11

(25.0)

49

(37.1)

7

(9.7)

 

11

(25.0)

41

(39.4)

15

(15.0)

 

21

(27.6)

38

(40.9)

8

(10.1)

 

> 8-≤14.5

47

(19.0)

6

(12.5)

19

(15.5)

22

(28.6)

 

4

(9.1)

23

(17.4)

20

(27.8)

 

6

(13.6)

16

(15.4)

25

(25.0)

 

10

(13.2)

17

(18.3)

20

(25.3)

 

> 14.5

62

(25.0)

0

20

(16.3)

42

(54.6)

 

0

19

(14.4)

43

(59.7)

 

1

(2.3)

11

(10.6)

50

(50.0)

 

1

(1.3)

17

(18.3)

44

(55.7)

 
  1. Abbreviations: SD standard deviation, HER2 human epidermal growth factor receptor 2, TN triple negative phenotype, TMA tissue microarray, HPF high power fields
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Diagnostic Pathology

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