Patient disposition and treatment exposure
| Parameter . | Bortezomib dose groups . | ||
|---|---|---|---|
| 1.6 mg/m2 QW (n = 18) . | 1.3 mg/m2 BIW (n = 34) . | Lower doses QW/BIW (n = 18) . | |
| Median number of cycles received, n (range) | 8 (1-39) | 6 (1-57) | 8 (3-57) |
| Mean actual dose received/planned dose of bortezomib, % | 89 | 81 | 98 |
| Received ≥ 8 cycles, n (%) | 10 (56) | 11 (32) | 11 (61) |
| Completed 8 cycles, n (%) | 9 (50) | 9 (26) | 10 (56) |
| Discontinued treatment, n (%) | 9 (50) | 25 (74) | 8 (44) |
| Adverse events | 5 (28) | 10 (29) | 3 (17) |
| Patient choice | 3 (17) | 4 (12) | 2 (11) |
| Disease progression | 1 (6) | 3 (9) | 0 |
| Clinical deterioration* | 0 | 2 (6) | 3 (17) |
| Death | 0 | 2 (6) | 0 |
| Other causes† | 0 | 4 (12) | 0 |
| Ongoing on treatment, n | 1 | 1 | 2‡ |
| Alive, n (%) | 11 (61) | 22 (65) | 9 (50) |
| Parameter . | Bortezomib dose groups . | ||
|---|---|---|---|
| 1.6 mg/m2 QW (n = 18) . | 1.3 mg/m2 BIW (n = 34) . | Lower doses QW/BIW (n = 18) . | |
| Median number of cycles received, n (range) | 8 (1-39) | 6 (1-57) | 8 (3-57) |
| Mean actual dose received/planned dose of bortezomib, % | 89 | 81 | 98 |
| Received ≥ 8 cycles, n (%) | 10 (56) | 11 (32) | 11 (61) |
| Completed 8 cycles, n (%) | 9 (50) | 9 (26) | 10 (56) |
| Discontinued treatment, n (%) | 9 (50) | 25 (74) | 8 (44) |
| Adverse events | 5 (28) | 10 (29) | 3 (17) |
| Patient choice | 3 (17) | 4 (12) | 2 (11) |
| Disease progression | 1 (6) | 3 (9) | 0 |
| Clinical deterioration* | 0 | 2 (6) | 3 (17) |
| Death | 0 | 2 (6) | 0 |
| Other causes† | 0 | 4 (12) | 0 |
| Ongoing on treatment, n | 1 | 1 | 2‡ |
| Alive, n (%) | 11 (61) | 22 (65) | 9 (50) |
KPS, Karnofsky performance status.
Clinical deterioration includes deterioration in KPS and organ function and deterioration in patients’ overall condition.
Other causes of discontinuation were attainment of CR after cycle 2, study drug intolerance, clinical progression on maintenance (treatment cycle 11), and plateaued hematologic response in cycle 4 (each n = 1).
One patient has progressed since data cutoff and discontinued treatment.