Median time to progression, response rate, median time to first response, and median duration of response in patients on the bortezomib arm in this updated analysis versus the initial analysis of bortezomib and high-dose dexamethasone
| . | Bortezomib update . | Bortezomib initial . | High-dose dexamethasone initial . |
|---|---|---|---|
| no. | 333 | 333 | 336 |
| Median TTP, mo* | 6.2 | 6.2 | 3.5 |
| Response rate CR + PR, % (n/N) | 43 (135/315) | 38 (121/315) | 18 (56/312) |
| CR | 9 (27/315) | 6 (20/315) | <1 (2/312) |
| PR† | 34 (108/315) | 32 (101/315) | 17 (54/312) |
| nCR | 7 (21/315) | 7 (21/315) | <1 (3/312) |
| Median TTR, mo† | 1.4 | 1.4 | 1.4 |
| CR | 0.8 | 0.8 | 0.8 |
| PR† | 1.4 | 1.4 | 1.4 |
| nCR | 0.8 | 0.8 | 0.8 |
| Median DOR, mo† | 7.8 | 8.0 | 5.6 |
| 100% M-protein reduction, CR/nCR; n = 40‡ | 11.5 | NE | NE |
| 50% or more but less than 100% M-protein | 7.6 | NE | NE |
| reduction, PR; n = 71‡ |
| . | Bortezomib update . | Bortezomib initial . | High-dose dexamethasone initial . |
|---|---|---|---|
| no. | 333 | 333 | 336 |
| Median TTP, mo* | 6.2 | 6.2 | 3.5 |
| Response rate CR + PR, % (n/N) | 43 (135/315) | 38 (121/315) | 18 (56/312) |
| CR | 9 (27/315) | 6 (20/315) | <1 (2/312) |
| PR† | 34 (108/315) | 32 (101/315) | 17 (54/312) |
| nCR | 7 (21/315) | 7 (21/315) | <1 (3/312) |
| Median TTR, mo† | 1.4 | 1.4 | 1.4 |
| CR | 0.8 | 0.8 | 0.8 |
| PR† | 1.4 | 1.4 | 1.4 |
| nCR | 0.8 | 0.8 | 0.8 |
| Median DOR, mo† | 7.8 | 8.0 | 5.6 |
| 100% M-protein reduction, CR/nCR; n = 40‡ | 11.5 | NE | NE |
| 50% or more but less than 100% M-protein | 7.6 | NE | NE |
| reduction, PR; n = 71‡ |
TTP indicates time to progression; CR, complete response; PR, partial response; nCR, near complete response; TTR, time to response; DOR, duration of response; and NE, not evaluated.
Median length of bortezomib therapy was 6 cycles, while responding patients received a median of 10 cycles (protocol-specified 8 cycles plus 2 additional maintenance cycles).
Based on responders in each group.
‡Based on patients with measurable baseline serum M-protein (n = 111).