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Table 2 Selected patient demographic and baseline characteristics by HER2 mRNA expression and treatment arm

From: Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer

Characteristic

HER2 mRNA < median (n = 58)

HER2 mRNA ≥ median (n = 58)

 

HT

T-DM1

Total

HT

T-DM1

Total

(n = 32)

(n = 26)

(n = 58)

(n = 29)

(n = 29)

(n = 58)

Median age, years (range)

52.5

54.5

53.5

51.0

54.0

53.0

(36 to 72)

(32 to 74)

32 to 74

(33 to 75)

(27 to 82)

(27 to 82)

World region, %

      

  US

34.4

38.5

36.2

24.1

27.6

25.9

  Non-US

65.6

61.5

63.8

75.9

72.4

74.1

Race, % a

      

  White

81.3

80.8

81.0

86.2

72.4

79.3

  American Indian or Alaskan native

9.4

7.7

8.6

6.9

6.9

6.9

  Black

6.3

0.0

3.4

3.4

6.9

5.2

  Other or not available

3.1

11.5

6.9

3.4

13.8

8.6

ECOG PS, %

      

  0

62.5

80.8

70.7

57.1

69.0

63.2

  1

37.5

19.2

29.3

42.9

31.0

36.8

HER2 status by central laboratory, %

      

  HER2-positive

71.9

73.1

72.4

100.0

100.0

100.0

  Normal

28.1

26.9

27.6

0.0

0.0

0.0

ER/PR status, % a

      

  ER-positive and/or PR-positive

65.6

57.7

62.1

48.3

44.8

46.6

  ER-negative and PR-negative

28.1

42.3

34.5

48.3

51.7

50.0

  ER and PR unknown

6.3

0

3.4

3.4

3.4

3.4

Number of distinct sites involved a

      

  1 to 2

43.8

30.8

37.9

50.0

44.8

47.4

  >2

56.3

69.2

62.1

50.0

55.2

52.6

  1. aPercentages may not add to 100% due to rounding. ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HT, trastuzumab plus docetaxel; mRNA, messenger RNA; PR, progesterone receptor; T-DM1, trastuzumab emtansine.