Table 2.
Best overall responses (n = 257*)
| All patients (n = 257) | Patients with unfavorable cytogenetic/FISH markers (n = 71) | |
|---|---|---|
| Response category, n (%) | ||
| Complete response | 1 (0.4) | 0 (0) |
| Very good partial response | 13 (5.1) | 3 (4.2) |
| Partial response | 47 (18.3) | 18 (25.4) |
| Minimal response | 34 (13.2) | 3 (4.2) |
| Stable disease | 81 (31.5) | 28 (39.4) |
| Progressive disease | 69 (26.8) | 15 (21.1) |
| Not evaluable | 12 (4.7) | 4 (5.6) |
| Overall response, n (%) | 61 (23.7) | 21 (29.6) |
| 95% CI | 18.7-29.4 | 19.3-41.6 |
| Clinical benefit rate, n (%) | 95 (37.0) | 24 (33.8) |
| 95% CI | 31.1-43.2 | 23.0-46.0 |
| PFS, median (95% CI), mo | 3.7 (2.8-4.6) | 3.6 (2.3-4.6) |
| Median duration of response, mo (95% CI)† | 7.8 (5.6-9.2) | 6.9 (3.7-8.5) |
| Mean treatment duration, mo (range)‡ | 3.0 (0.03-16.9) | 3.6 (0-11.1) |
*
Response-evaluable population.
†
Calculated for patients with partial response or better.
‡
Before the opening of the extension study (PX-171-010), individual protocol exceptions were granted for 7 patients to continue receiving treatment beyond 12 cycles.