Table. Efficacy Results From Phase 2.
| T-DM1 + capecitabine (n = 81) | T-DM1 (n = 80) | |
|---|---|---|
| Overall response rate, No. (%) [90% CI] | 36 (44.4) [35.0 to 54.2] | 29 (36.3) [27.3 to 46.0] |
| Difference, % (90% CI) | 8.2 (−4.5 to 20.9) | |
| P value | .34 | |
| Clinical benefit rate, No. (%) [90% CI] | 54 (66.7) [57.1 to 75.3] | 50 (62.5) [52.7 to 71.6] |
| Best overall response, No. (%) | ||
| Complete response | 2 (2) | 2 (3) |
| Partial response | 34 (42) | 27 (34) |
| Stable disease | 24 (30) | 26 (33) |
| Progressive disease | 14 (17) | 23 (29) |
| Not evaluable | 7 (9) | 2 (3) |
| Time to response, median (IQR), moa | 2.10 (1.99 to 3.24) | 2.10 (2.04 to 4.67) |
| Duration of response, median (IQR), moa | 11.30 (8.18 to NE) | 12.22 (8.25 to 19.88) |
| Time to treatment failure, median (IQR), mo | 9.86 (4.67 to 15.87) | 7.66 (4.27 to 14.52) |
| Time to progression, median (IQR), mo | 10.38 (4.93 to NE) | 10.32 (4.83 to 18.43) |
Abbreviations: IQR, interquartile range; NE, not estimable; T-DM1, trastuzumab emtansine.
a
Provided for responders only.