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Table 1 Selected patient demographic and baseline characteristics by 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 HT (n = 70) T-DM1 (n = 67)
Median age, years (range) 52.0 (33 to 75) 55.0 (27 to 82)
World region, %   
  North America 28.6 31.3
  Central and South America 28.6 23.9
  Europe 42.9 44.8
Race, %   
  White 82.9 77.6
  American Indian or Alaskan native 10.0 7.5
  Black 4.3 4.5
  Other or not available 2.9 10.4
ECOG PS, %   
  0 63.8a 65.7
  1 36.2a 34.3
HER2 status by central laboratory, % b   
  HER2-positive 85.9 85.7
  Normal 14.1 14.3
ER/PR status, %   
  ER-positive and/or PR-positive 54.3 49.3
  ER-negative and PR-negative 41.4 47.8
  ER and PR unknown 4.3 3.0
Stage at initial diagnosis, %   
  Stage I to III 68.1a 58.2
  Stage IV 29.0a 34.3
  Unknown 2.9a 7.5
Number of distinct sites of involvement   
  1 to 2 49.3a 35.8
  >2 50.7a 64.2
Lung or liver involvement. %   
  Yes 67.1 71.6
  No 31.4 26.9
  Unknown 1.4 1.5
Disease-free interval, %   
  ≤24 months 64.3 59.7
  >24 months 35.7 40.3
Prior treatment. %   
  Trastuzumab 27.1 17.9
  Taxane 40.0 32.8
  Anthracycline 48.6 44.8
Total number of prior chemotherapy agents, median (range) 3 (1 to 4) 3 (1 to 6)
  1. Reproduced with permission from Hurvitz et al. [10]. aData were available for 69 patients in the HT arm. bCentral testing for HER2 status was performed for 64 patients in the HT arm and 63 patients in the T-DM1 arm. ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HT, trastuzumab plus docetaxel; PR, progesterone receptor; T-DM1, trastuzumab emtansine.