Skip to main content

Table 1 Baseline patient and tumor characteristics (ITT population)

From: Association of phosphatase and tensin homolog low and phosphatidylinositol 3-kinase catalytic subunit alpha gene mutations on outcome in human epidermal growth factor receptor 2-positive metastatic breast cancer patients treated with first-line lapatinib plus paclitaxel or paclitaxel alone

Characteristics

Lapatinib + paclitaxel (n = 222)

Placebo + paclitaxel (n = 222)

Median age, years (range)

50.0 (25-74)

50.5 (26-73)

Race, n (%)

  

  Asian

192 (86)

192 (86)

  Other

30 (14)

30 (14)

ECOG performance status, n (%)

  

  0

103 (46)

113 (51)

  1

119 (54)

109 (49)

Central HER2 FISH + a, n (%)

219 (99)

218 (99)

Hormone receptor-positive, n (%)

111 (50)

113 (51)

Any visceral disease, n (%)

187 (84)

186 (84)

Median time since first diagnosis, months

25.7

23.6

Prior anticancer therapies b , n (%)

  

  Any therapy

171 (77)

182 (82)

  Chemotherapy

160 (72)

173 (78)

  Adjuvant

146 (66)

161 (73)

  Hormonal therapy

53 (24)

44 (20)

  Biologic

0

4 (2)

  Radiotherapy

94 (42)

85 (38)

  1. aFive cases were HER2 FISH-borderline: three from lapatinib + paclitaxel, two from placebo + paclitaxel; two additional cases from placebo + paclitaxel never FISH-tested. bA total of 12% of the study population had Stage IV breast cancer at initial disease presentation (14% in lapatinib + paclitaxel; 11% in placebo + paclitaxel). ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; ITT, intent-to-treat.