Hematologic response, disease progression, and overall survival
| Parameter . | Bortezomib dose groups . | ||
|---|---|---|---|
| 1.6 mg/m2 QW . | 1.3 mg/m2 BIW . | Lower doses QW/BIW . | |
| Hematologic response | n = 16 | n = 33 | n = 18 |
| Best confirmed hematologic response rate (CR+PR), n (%) | 11 (68.8) | 22 (66.7) | 7 (38.9) |
| CR rate, n (%) | 6 (37.5) | 8 (24.2) | 3 (16.7) |
| Median time to hematologic response, months (range) | n = 11 | n = 22 | n = 7 |
| To first response | 2.1 (0.9-6.9) | 0.7 (0.3-4.0) | 1.2 (0.6-4.8) |
| To best confirmed response | 3.2 (0.9-7.2) | 1.2 (0.3-7.6) | 1.2 (0.6-39.6) |
| 1-year DOR rate, %* | 80.0 | 80.0 | 83.3 |
| Hematologic disease progression | |||
| Median follow-up, months (range) | 21.6 (0-35) | 11.3 (0-18) | 9.9 (2-49) |
| Patients progressing, n | 4 | 5 | 4 |
| 1-year hematologic disease progression-free rate, % | 72.2 | 76.8 | 88.5 |
| OS | |||
| Median follow-up, months (range) | 51.8 (1-68) | 46.1 (1-61) | 66.1 (2-80) |
| Deaths, n | 7 | 12 | 9 |
| Median OS, months (95% CI) | 62.1 (50.1-NE) | NE (30.2-NE) | 63.2 (45.4-NE) |
| 4-year OS rate, % | 75.0 | 63.0 | 69.7 |
| Parameter . | Bortezomib dose groups . | ||
|---|---|---|---|
| 1.6 mg/m2 QW . | 1.3 mg/m2 BIW . | Lower doses QW/BIW . | |
| Hematologic response | n = 16 | n = 33 | n = 18 |
| Best confirmed hematologic response rate (CR+PR), n (%) | 11 (68.8) | 22 (66.7) | 7 (38.9) |
| CR rate, n (%) | 6 (37.5) | 8 (24.2) | 3 (16.7) |
| Median time to hematologic response, months (range) | n = 11 | n = 22 | n = 7 |
| To first response | 2.1 (0.9-6.9) | 0.7 (0.3-4.0) | 1.2 (0.6-4.8) |
| To best confirmed response | 3.2 (0.9-7.2) | 1.2 (0.3-7.6) | 1.2 (0.6-39.6) |
| 1-year DOR rate, %* | 80.0 | 80.0 | 83.3 |
| Hematologic disease progression | |||
| Median follow-up, months (range) | 21.6 (0-35) | 11.3 (0-18) | 9.9 (2-49) |
| Patients progressing, n | 4 | 5 | 4 |
| 1-year hematologic disease progression-free rate, % | 72.2 | 76.8 | 88.5 |
| OS | |||
| Median follow-up, months (range) | 51.8 (1-68) | 46.1 (1-61) | 66.1 (2-80) |
| Deaths, n | 7 | 12 | 9 |
| Median OS, months (95% CI) | 62.1 (50.1-NE) | NE (30.2-NE) | 63.2 (45.4-NE) |
| 4-year OS rate, % | 75.0 | 63.0 | 69.7 |
NE, not estimable.
Based on Kaplan-Meier analysis.