Table 1.

Distribution of patient and tumor characteristics

EGF100151 clinical trial
All
HER-2 positive*
HER-2 negative
Capecitabine and lapatinib (n = 198)Capecitabine alone (n = 201)Capecitabine and lapatinib (n = 139)Capecitabine alone (n = 132)Capecitabine and lapatinib (n = 28)Capecitabine alone (n = 27)
Mean (range) age, y54 (26-80)52 (28-83)53 (32-80)51 (30-83)55 (29-79)56 (40 - 80)
Stage
    IIIb-c (%)7 (4)8 (4)7 (5)5 (4)00
    IV (%)191 (96)193 (96)132 (95)127 (96)28 (100)27 (100)
Visceral metastasis (%)153 (77)158 (79)104 (75)100 (76)21 (75)24 (89)
EGF30001 clinical trial
All
HER-2 positive*
HER-2 negative
Paclitaxel and lapatinib (n = 291)
Paclitaxel alone (n = 287)
Paclitaxel and lapatinib (n = 49)
Paclitaxel alone (n = 37)
Paclitaxel and lapatinib (n = 202)
Paclitaxel alone (n = 206)
Mean (range) age, y51.3 (23-87)52.4 (25-78)51 (34-75)51 (28-78)52 (23-74)52 (26-78)
Stage
    IIIb-c (%)37 (13)40 (14)6 (12)8 (22)26 (13)21 (10)
    IV (%)254 (87)247 (86)43 (88)29 (78)168 (87)182 (90)
Visceral metastasis (%)183 (63)184 (64)34 (69)19 (51)125 (62)138 (67)
  • * HER-2-positive status: FISH-positive (n = 344) or if FISH unknown, IHC 3+ (n = 13).

  • HER-2-negative status: FISH-negative (n = 389) or if FISH unknown, IHC 2+, 1+, or 0 (n = 74).

  • With or without other metastases.