Table 1.

Baseline characteristics of the patients included in ALTTO (intention-to-treat population; N = 6281 patients)

Variable	T (N = 2097) N (%)	L + T (N = 2093) N (%)	T → L (N = 2091) N (%)
Region, n (%)
North America (region 1)	230 (11)	233 (11)	244 (12)
South America (region 2)	113 (5)	104 (5)	113 (5)
Europe (region 3)	1118 (53)	1128 (54)	1112 (53)
Asia Pacific and South Africa (region 4)	636 (30)	628 (30)	622 (30)
Race, n (%)
White	1451 (69)	1445 (69)	1454 (69)
Asian	555 (26)	546 (26)	543 (25)
Black	25 (1)	38 (1)	30 (1)
Other/missing	66 (3)	64 (3)	64 (3)
Age, n (%)
Median age, years (range)	51 (18-80)	51 (22-80)	51 (22-80)
<65 years	1881 (90)	1879 (90)	1877 (90)
≥65 years	216 (10)	214 (10)	214 (10)
Menopausal status, n (%)
Premenopausal	908 (43)	909 (43)	929 (44)
Postmenopausal [or male]	1189 [0] (57)	1184 [2] (57)	1162 [5] (56)
Nodal status, n (%)
Not applicable (neoadj. CT)	181 (9)	168 (8)	170 (8)
Negative	844 (40)	845 (40)	842 (40)
1-3 positive nodes	603 (29)	617 (29)	617 (30)
≥4 positive nodes	469 (22)	463 (22)	462 (22)
Pathological tumor size, n (%)
Not applicable (neoadj. CT)	181 (9)	168 (8)	170 (8)
≤2 cm	855 (41)	864 (41)	858 (41)
>2 cm to ≤5 cm	937 (45)	939 (45)	935 (45)
>5 cm	115 (5)	113 (5)	119 (6)
Missing	9 (<1)	9 (<1)	9 (<1)
Hormone receptor status, n (%)
Positive	1200 (57)	1203 (57)	1205 (58)
Negative	897 (43)	890 (43)	886 (42)
Histologic grade, n (%)
Cannot be assessed	59 (3)	79 (4)	61 (3)
Well differentiated	48 (2)	51 (2)	59 (3)
Moderately differentiated	744 (36)	774 (37)	793 (38)
Poorly differentiated	1237 (59)	1179 (57)	1171 (56)
Missing	9	10	7
Timing of chemotherapy, n (%)
Sequential (design 1)	1147 (55)	1155 (55)	1143 (55)
Concurrent (design 2/2B)	950 (45)	938 (45)	948 (45)

CT, chemotherapy; neoadj., neoadjuvant; L + T, lapatinib + trastuzumab; T, trastuzumab; T→L, trastuzumab followed by lapatinib.