Table 1.
Baseline demographics and disease characteristics of the Asian patients
| Characteristics | N+C (n = 104) | L+C (n = 98) | Total (N = 202) |
|---|---|---|---|
| Age (years at enrollment) | |||
| Mean (SD) | 56.2 (9.9) | 53.4 (10.4) | 54.8 (10.2) |
| Age group | |||
| < 65 years | 86 (82.7) | 84 (85.7) | 170 (84.2) |
| ≥ 65 years | 18 (17.3) | 14 (14.3) | 32 (15.8) |
| Sex | |||
| Female | 104 (100) | 96 (98.0) | 200 (99.0) |
| Male | 0 (0.0) | 2 (2.0) | 2 (1.0) |
| ECOG PS at enrollment | |||
| 0 | 69 (66.3) | 53 (54.1) | 122 (60.4) |
| 1 | 35 (33.7) | 45 (45.9) | 80 (39.6) |
| Hormone receptor statusa | |||
| Negative | 56 (53.8) | 48 (49.0) | 104 (51.5) |
| Positive | 48 (46.2) | 50 (51.0) | 98 (48.5) |
| Disease location | |||
| Non visceral | 27 (26.0) | 22 (22.4) | 49 (24.3) |
| Visceral | 77 (74.0) | 76 (77.6) | 153 (75.7) |
| Histological grade at diagnosis | |||
| Well differentiated | 4 (3.8) | 3 (3.1) | 7 (3.5) |
| Moderately differentiated | 34 (32.7) | 23 (23.5) | 57 (28.2) |
| Poorly differentiated | 41 (39.4) | 35 (35.7) | 76 (37.6) |
| Undifferentiated | 2 (1.9) | 1 (1.0) | 3 (1.5) |
| Unknown | 23 (22.1) | 36 (36.7) | 59 (29.2) |
| Prior anticancer therapy | |||
| Neoadjuvant | 14 (13.5) | 18 (18.4) | 32 (15.8) |
| Adjuvant | 49 (47.1) | 36 (36.7) | 85 (42.1) |
| Metastatic/locally advanced | 104 (100.0) | 98 (100.0) | 202 (100.0) |
| Number of previous HER2-directed regimens | |||
| 2 | 73 (70.2) | 70 (71.4) | 143 (70.8) |
| ≥ 3 | 31 (29.8) | 28 (28.6) | 59 (29.2) |
| Prior HER2-directed therapies | |||
| Trastuzumab only | 65 (62.5) | 56 (57.1) | 121 (59.9) |
| Trastuzumab and pertuzumab | 7 (6.7) | 10 (10.2) | 17 (8.4) |
| Trastuzumab and T-DM1 | 14 (13.5) | 17 (17.3) | 31 (15.3) |
| Trastuzumab, pertuzumab, and T-DM1 | 18 (17.3) | 15 (15.3) | 33 (16.3) |
| Location of disease at enrollment in the brain | |||
| Yes | 18 (17.3) | 19 (19.4) | 37 (18.3) |
| No | 86 (82.7) | 79 (80.6) | 165 (81.7) |
Data are presented as n (%), unless otherwise stated
ECOG PS eastern cooperative oncology group performance status, ER estrogen receptor, L+C lapatinib plus capecitabine, N+C neratinib plus capecitabine, PR progesterone receptor, SD standard deviation, T-DM1 trastuzumab emtansine
aHormone receptor positive: ER positive, PR positive, or both. Hormone receptor negative: ER and PR negative