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Table 3 Efficacy outcomes by tumor HER2 expression below the median and equal to or greater than the median

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

 

Median PFS, months

 

HER2 expressiona

HT

T-DM1

HR relative to HT (95% CI)

  All patients

(n = 70)

(n = 67)

0.59 (0.36, 0.97)

9.2

14.2

  < Median

(n = 32)

(n = 26)

0.85 (0.44, 1.67)

9.8

10.6

  ≥ Median

(n = 29)

(n = 29)

0.39 (0.18, 0.85)

8.8

Not reached

 

ORR,%

 

HER2 expression a

HT

T-DM1

Odds ratio relative to HT (95% CI)

  All patients

(n = 69)

(n = 67)

1.26 (0.63, 2.55)

58.0

64.2

  < Median

(n = 31)

(n = 26)

0.84 (0.30, 2.41)

58.1

53.8

  ≥ Median

(n = 29)

(n = 29)

1.58 (0.50, 4.98)

65.5

72.4

  1. aHER2 mRNA data were available for 61 of 70 patients in the HT arm and for 55 of 67 patients in the T-DM1 arm. HER2, human epidermal growth factor receptor 2; HT, trastuzumab plus docetaxel; ORR, objective response rate; PFS, progression-free survival; T-DM1, trastuzumab emtansine.