Response rates after 6 cycles of treatment in response-evaluable population
| . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 67) . | Total (N = 126) . |
|---|---|---|---|
| Best response, n (%) | |||
| CR | 2 (3.4) | 1 (1.5) | 3 (2.4) |
| VGPR | 8 (13.6) | 18 (26.9) | 26 (20.6) |
| PR | 15 (25.4) | 16 (23.9) | 31 (24.6) |
| MR | 10 (16.9) | 8 (11.9) | 18 (14.3) |
| SD | 13 (22.0) | 10 (14.9) | 23 (18.3) |
| PD | 7 (11.9) | 11 (16.4) | 18 (14.3) |
| ORR (CR + VGPR + PR), n (%) | 25 (42.4) | 35 (52.2) | 60 (47.6) |
| 95% CI* | 29.6-55.9 | 39.7-64.6 | 38.7-56.7 |
| CBR (ORR + MR), n (%) | 35 (59.3) | 43 (64.2) | 78 (61.9) |
| 95% CI* | 45.7-71.9 | 51.5-75.5 | 52.8-70.4 |
| . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 67) . | Total (N = 126) . |
|---|---|---|---|
| Best response, n (%) | |||
| CR | 2 (3.4) | 1 (1.5) | 3 (2.4) |
| VGPR | 8 (13.6) | 18 (26.9) | 26 (20.6) |
| PR | 15 (25.4) | 16 (23.9) | 31 (24.6) |
| MR | 10 (16.9) | 8 (11.9) | 18 (14.3) |
| SD | 13 (22.0) | 10 (14.9) | 23 (18.3) |
| PD | 7 (11.9) | 11 (16.4) | 18 (14.3) |
| ORR (CR + VGPR + PR), n (%) | 25 (42.4) | 35 (52.2) | 60 (47.6) |
| 95% CI* | 29.6-55.9 | 39.7-64.6 | 38.7-56.7 |
| CBR (ORR + MR), n (%) | 35 (59.3) | 43 (64.2) | 78 (61.9) |
| 95% CI* | 45.7-71.9 | 51.5-75.5 | 52.8-70.4 |
PD indicates progressive disease; and SD, stable disease.
Exact 95% CI for ORR and CBR rate.