Efficacy outcomes and follow-up status
| . | Arm B (4 mg) (N = 35) . | Arm C (5.5 mg) (N = 35) . |
|---|---|---|
| ORR | 31% (95% CI, 17-49) | 54% (95% CI, 37-71) |
| No. of responders | 11 | 19 |
| sCR | 0 | 1 |
| CR | 1 | 0 |
| VGPR | 7 | 10 |
| PR | 3 | 8 |
| MR | 5 | 1 |
| Median OS* | NA | NA |
| % alive at 6 mo | 100 | 100 |
| Median EFS* | 8.4 mo (95% CI, 4.5-12.8) | 7.8 mo (95% CI, 4.6-11.9) |
| %Event free at 6 mo | 60% (95% CI, 46-79) | 60% (95% CI, 46-79) |
| Median duration of response | 16.7 mo (95% CI, 9.3-NA) | 16.3 mo (95% CI, 8.6-NA) |
| Median time to response, mo (range) | 1.1 (0.8-3.6) | 1.0 (0.8-13.0) |
| Patients with progression, N (%) | 19 (54.0) | 25 (71.4) |
| Patients alive, N (%) | 30 (85.7) | 31 (88.6) |
| Median follow-up (alive patients), mo (range) | 16.2 (0.9-30.7) | 16.3 (2.0-28.7) |
| Last cycle administered | 8 (1-27) | 7 (1-31) |
| Patients with new treatment | 22 (63%) | 23 (66%) |
| Before disease progression | 2 | 0 |
| On treatment | 9 | 6 |
| Reason for ending treatment, N (%) | ||
| Refused further treatment | 3 (11.5) | 2 (6.9) |
| AE | 2 (7.7) | 3 (10.3) |
| Disease progression | 16 (61.5) | 22 (75.9) |
| Alternate treatment | 4 (15.4) | 2 (6.9) |
| Physician discretion | 1 (3.8) | 0 (0.0) |
| . | Arm B (4 mg) (N = 35) . | Arm C (5.5 mg) (N = 35) . |
|---|---|---|
| ORR | 31% (95% CI, 17-49) | 54% (95% CI, 37-71) |
| No. of responders | 11 | 19 |
| sCR | 0 | 1 |
| CR | 1 | 0 |
| VGPR | 7 | 10 |
| PR | 3 | 8 |
| MR | 5 | 1 |
| Median OS* | NA | NA |
| % alive at 6 mo | 100 | 100 |
| Median EFS* | 8.4 mo (95% CI, 4.5-12.8) | 7.8 mo (95% CI, 4.6-11.9) |
| %Event free at 6 mo | 60% (95% CI, 46-79) | 60% (95% CI, 46-79) |
| Median duration of response | 16.7 mo (95% CI, 9.3-NA) | 16.3 mo (95% CI, 8.6-NA) |
| Median time to response, mo (range) | 1.1 (0.8-3.6) | 1.0 (0.8-13.0) |
| Patients with progression, N (%) | 19 (54.0) | 25 (71.4) |
| Patients alive, N (%) | 30 (85.7) | 31 (88.6) |
| Median follow-up (alive patients), mo (range) | 16.2 (0.9-30.7) | 16.3 (2.0-28.7) |
| Last cycle administered | 8 (1-27) | 7 (1-31) |
| Patients with new treatment | 22 (63%) | 23 (66%) |
| Before disease progression | 2 | 0 |
| On treatment | 9 | 6 |
| Reason for ending treatment, N (%) | ||
| Refused further treatment | 3 (11.5) | 2 (6.9) |
| AE | 2 (7.7) | 3 (10.3) |
| Disease progression | 16 (61.5) | 22 (75.9) |
| Alternate treatment | 4 (15.4) | 2 (6.9) |
| Physician discretion | 1 (3.8) | 0 (0.0) |
NA, not attained.
Kaplan Meier.