Table 5.
Patient characteristics and outcomes in the present study, the EMILIA study, and the TH3RESA study.
| Present Study N = 15 N (%) | EMILIA (Verma et al. 2012) N = 991 N (%) | TH3RESA (Krop et al. 2017; Krop et al. 2014) N = 602 N (%) | |||
|---|---|---|---|---|---|
| Treatment | T-DM1 | Cap + Lap N = 496 | T-DM1 N = 495 | PC N = 198 |
T-DM1 N = 404 |
| Age, median (range) | 45 (36–71) | 53 (24–83) | 53 (25–84) | 54 (28–85) | 53 (27–89) |
| ECOG PS | |||||
| 0 | 3 (20) | 312 (64) | 299 (61) | 82 (41) | 180 (45) |
| 1 | 1 (73) | 176 (36) | 194 (39) | 101 (51) | 200 (50) |
| 2 | 1 (7) | 0 | 0 | 15 (8) | 22 (5) |
| HR status | |||||
| ER+ and/or PR+ | 11 (73) | 263 (62) | 282 (57) | 103 (52) | 208 (51) |
| ER− and PR− | 4 (27) | 224 (45) | 202 (41) | 85 (43) | 185 (46) |
| Unknown | 9 (2) | 11 (2) | 10 (5) | 11 (3) | |
| Visceral disease involvement | |||||
| Yes | 9 (60) | 335 (68) | 334 (67) | 150 (76) | 302 (75) |
| No | 6 (40) | 161 (32) | 161 (33) | 48 (24) | 102 (25) |
| Number of metastatic sites | |||||
| <3 | 9 (60) | 307 (62) | 298 (60) | na | na |
| ≥3 | 6 (40) | 175 (35) | 189 (38) | ||
| Unknown | 0 | 14 (3) | 8 (2) | ||
| CNS metastases | 5 (33) | 50 (10) | 45 (9) | 27 (14) | 40 (10) |
| Previous treatment | |||||
| Median number of treatment lines | 2.5 | 3 | 3 | 4 | 4 |
| Taxanes | 13 (87) | 494 (100) | 493 (100) | na | na |
| Anthracyclines | 9 (60) | 302 (61) | 303 (61) | na | na |
| Hormonal therapy | 7 (47) | 204 (41) | 205 (41) | na | na |
| Trastuzumab | 15 (100) | 495 (100) | 205 (100) | 198 (100) | 404 (100) |
| Lapatinib | 12 (80) | 0 | 0 | 198 (100) | 404 (100) |
| PFS (months) | 10 | 6.4 | 9.6 | 3.3 | 6.2 |
| OS (months) | 34 | 25.1 | 30.9 | 15.8 | 22.7 |
| ORR | 73.3% | 30.8% | 43.6% | 9% | 31% |
| Grade 3–4 toxicities | |||||
| Elevated transaminases | 1 (6.7) | 10 (2.2) | 35 (7.2) | 4 (2) | 24 (6) |
| Thrombocytopenia | 1 (6.7) | 1 (0.2) | 64 (12.9) | 3 (1) | 19 (4) |
| Anemia | 1 (6.7) | 8 (1.6) | 13 (2.7) | 5 (3) | 11 (3) |
| Neutropenia | 1 (6.7) | 21 (4.3) | 10 (2.0) | 29 (16) | 10 (3) |
| Hypokalemia | 1 (6.7) | 20 (4.1) | 11 (2.2) | na | na |
Cap + Lap, capecitabine plus lapatinib; PC, physician’s choice; ECOG, Eastern Cooperative Oncology Group; PS, performance status; HR, hormone receptor; ER, estrogen receptor; PR, progesterone receptor; na, data not available; CNS, central nervous system; PFS, progression-free survival; OS, overall survival; ORR, overall response rate.