Table 3 Patient characteristics and outcomes in the present study, the EMILIA study, and the TH3RESA study.
Variables | EMILIA Study | TH3RESA study | This Study | ||
|---|---|---|---|---|---|
Cap + Lap N = 496 | TDM1 N = 495 | Physician’s choice chemotherapy N = 198 | T-DM1 N = 404 | N = 70 | |
Age, median (range) | 53 (24–83) | 53 (25–84) | 54 (28–85) | 53 (27–89) | 47 (29–68) |
ECOG Performance Status | |||||
0 | 312 (64) | 299 (61) | 82 (41) | 180 (45) | 5 (7.1) |
1 | 176 (36) | 194 (39) | 101 (51) | 200 (50) | 60 (85.7) |
2 | 0 | 0 | 15 (8) | 22 (5) | 5 (7.1) |
Hormonal Receptor Status | |||||
ER + and/or PR + | 263 (62) | 282 (57) | 103 (52) | 208 (51) | 45 (64.3) |
ER − and PR − | 224 (45) | 202 (41) | 85 (43) | 185 (46) | 25 (35.7) |
Unknown | 9 (2) | 11 (2) | 10 (5) | 11 (3) | –––––– |
Visceral metastasis | |||||
Yes | 335 (68) | 334 (67) | 150 (76) | 302 (75) | 46 (65.7) |
No | 161 (32) | 161 (33) | 48 (24) | 102 (25) | 24 (34.3) |
Number of metastatic sites | |||||
< 3 | 307 (62) | 298 (60) | NA | NA | 31 (44.3) |
≥ 3 | 175 (35) | 189 (38) | 39 (55.7) | ||
Unknown | 14 (3) | 8 (2) | –- | ||
CNS metastases | 50 (10) | 45 (9) | 27 (14) | 40 (10) | 28 (40) |
Median number of treatment lines | 3 | 3 | 4 | 4 | 2.5 (range 1–7) |
Previous treatments administered | |||||
Taxanes | 494 (100) | 493 (100) | NA | NA | 55 (78.6%) |
Anthracyclines | 302 (61) | 303 (61) | NA | NA | 28 (40%) |
Hormonal therapy | 204 (41) | 205 (41) | NA | NA | 40 (25.7%) |
Trastuzumab | 495 (100) | 205 (100) | 198 (100) | 404 (100) | 70 (100%) |
Lapatinib | 0 | 0 | 198 (100) | 404 (100) | 49 (70%) |
Efficacy outcomes | |||||
PFS (months) | 6.4 | 9.6 | 3.3 | 6.2 | 6.1 |
OS (months) | 25.1 | 30.9 | 15.8 | 22.7 | 14.4 |
ORR | 30.8% | 43.6% | 9% | 31% | 75.7% |
Grade 3/4 toxicities | |||||
Elevated transaminases | 10 (2.2) | 35 (7.2) | 4 (2) | 24 (6) | 6 (8.5%) |
Thrombocytopenia | 1 (0.2) | 64 (12.9) | 3 (1) | 19 (4) | 4 (5.7%) |
Anemia | 8 (1.6) | 13 (2.7) | 5 (3) | 11 (3) | 3 (4.2%) |
Neutropenia | 21 (4.3) | 10 (2.0) | 29 (16) | 10 (3) | 1 (1.4%) |
Hypokalemia | 20 (4.1) | 11 (2.2) | NA | NA | 1 (1.4%) |
