Table 1.
Baseline patient and disease characteristics
| Characteristics | XL |
T-DM1 |
||
|---|---|---|---|---|
| Patients with CNS metastases at baseline (N = 50) | ITT population (N = 496) | Patients with CNS metastases at baseline (N = 45) | ITT population (N = 495) | |
| Age, median (range) | 53 (34–80) | 53 (24–83) | 51 (27–71) | 53 (25–84) |
| Race, n (%) | ||||
| White | 38 (76.0) | 374 (75.4) | 28 (62.2) | 358 (72.3) |
| Asian | 8 (16.0) | 86 (17.3) | 15 (33.3) | 94 (19.0) |
| Black or African American | 3 (6.0) | 21 (4.2) | 2 (4.4) | 29 (5.9) |
| Other | 1 (2.0) | 10 (2.0) | 0 | 7 (1.4) |
| Not available | 0 | 5 (1.0) | 0 | 7 (1.4) |
| World region, n (%) | ||||
| United States | 17 (34.0) | 136 (27.4) | 4 (8.9) | 134 (27.1) |
| Western Europe | 14 (28.0) | 160 (32.3) | 12 (26.7) | 157 (31.7) |
| Asia | 8 (16.0) | 76 (15.3) | 15 (33.3) | 82 (16.6) |
| Other | 11 (22.0) | 124 (25.0) | 14 (31.1) | 122 (24.6) |
| ECOG PS,a n (%) | ||||
| 0 | 24 (49.0) | 312 (63.9) | 22 (48.9) | 299 (60.6) |
| 1 | 25 (51.0) | 176 (36.1) | 23 (51.1) | 194 (39.4) |
| ER and PR status, n (%) | ||||
| ER-positive and/or PR-positive | 23 (46.0) | 264 (53.2) | 25 (55.6) | 282 (57.0) |
| ER-negative and PR-negative | 27 (54.0) | 224 (45.2) | 19 (42.2) | 202 (40.8) |
| Other | 0 | 8 (1.6) | 1 (2.2) | 11 (2.2) |
| Menopausal status, n (%) | ||||
| Premenopausal | 22 (44.0) | 229 (46.2) | 19 (42.2) | 222 (44.8) |
| Perimenopausal | 1 (2.0) | 16 (3.2) | 3 (6.7) | 22 (4.4) |
| Postmenopausal | 25 (50.0) | 204 (41.1) | 19 (42.2) | 196 (39.6) |
| Unknown | 2 (4.0) | 38 (7.7) | 3 (6.7) | 41 (8.3) |
| N/A | 0 | 9 (1.8) | 1 (2.2) | 14 (2.8) |
| Baseline LVEF by local assessment,b median (range) | 60.0 (52.0–83.0) | 61.0 (50.0–88.0) | 62.0 (50.0–76.0) | 62.0 (50.0–87.0) |
| Segmental wall abnormality at baseline by local assessment,c n (%) | ||||
| No | 46 (92.0) | 471 (95.0) | 45 (100) | 477 (96.6) |
| Yes | 4 (8.0) | 25 (5.0) | 0 | 17 (3.4) |
| Number of sites of disease per IRC, n (%) | ||||
| 1 | 0 | 151 (30.4) | 1 (2.2) | 143 (28.9) |
| 2 | 8 (16.0) | 156 (31.5) | 7 (15.6) | 155 (31.3) |
| ≥3 | 42 (84.0) | 175 (35.3) | 37 (82.2) | 189 (38.2) |
| Unknown | 0 | 14 (2.8) | 0 | 8 (1.6) |
| Disease involvement, n (%) | ||||
| Visceral | 38 (76.0) | 335 (67.5) | 37 (82.2) | 334 (67.5) |
| Nonvisceral | 12 (24.0) | 161 (32.5) | 8 (17.8) | 161 (32.5) |
| Measurable disease per IRC, n (%) | 43 (86.0) | 389 (78.4) | 38 (84.4) | 397 (80.2) |
| Number of prior systemic agents in any setting,d median (range) | 4 (2–13) | 5 (2–13) | 5 (2–10) | 5 (2–17) |
| Number of prior systemic agents in the metastatic setting,d,e median (range) | 3 (1–13) | 3 (1–13) | 3 (1–8) | 3 (1–9) |
| Prior radiotherapy for CNS metastases, n (%) | ||||
| Whole-brain radiation | 30 (60.0) | – | 23 (51.1) | – |
| Local treatment | 5 (10.0) | – | 8 (17.8) | – |
| None | 15 (30.0) | – | 14 (31.1) | – |
aCNS metastases: XL, n = 49; T-DM1, n = 45; ITT: XL, n = 488; T-DM1, n = 493.
bCNS metastases: XL, n = 46; T-DM1, n = 43; ITT: XL, n = 472; T-DM1, n = 489.
cCNS metastases: XL, n = 50; T-DM1, n = 45; ITT: XL, n = 496; T-DM1, n = 494.
dExcluding hormonal therapy.
eCNS metastases: XL, n = 46; T-DM1, n = 42; ITT: XL, n = 430; T-DM1, n = 429.
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; IRC, independent review committee; ITT, intent-to-treat; LVEF, left ventricular ejection fraction; N/A, not applicable; PR, progesterone receptor; T-DM1, trastuzumab emtansine; XL, capecitabine–lapatinib.