Table 2. Patient disposition.
| Escalation (n=12) | MTD with IV bortezomib (n=10) | MTD with SC bortezomib (n=12) | Total (N=34) | |
|---|---|---|---|---|
| On treatment, n (%) | 0 | 0 | 0 | 0 |
| Discontinued, n (%) | 12 (100) | 10 (100) | 12 (100) | 34 (100) |
| PD | 9 (75) | 6 (60) | 7 (58) | 22 (65) |
| Consent withdrawn | 2 (17) | 1 (10) | 0 | 3 (9) |
| AE | 0 | 1 (10)a | 0 | 1 (3) |
| Death | 0 | 0 | 1 (8)b | 1 (3) |
| Lost to follow-up | 0 | 0 | 1 (8) | 1 (3) |
| Other | 1 (8)c | 2 (20)d | 3 (25)e | 6 (18) |
Abbreviations: AE, adverse event; IV, intravenous; MTD, maximum tolerated dose; PD, progressive disease; SC, subcutaneous.
a
One patient discontinued study treatment in cycle 2 due to metastatic pancreatic cancer unrelated to treatment.
b
One patient died due to cardiac arrest unrelated to treatment in cycle 3.
c
One patient was unable to switch to SC bortezomib.
d
One patient proceeded to transplant and 1 patient discontinued for noncompliance.
e
Two patients proceeded to transplant and 1 patient discontinued due to clinical progression.