Table 2. Patients treated and DLTs observed by bortezomib and docetaxel dose level.
| Bortezomib (mg m−2) | Docetaxel (mg m−2) | Treated n | MTD evaluablea n | DLT |
|---|---|---|---|---|
| 1.0 | 60 | 3 | 3 | — |
| 1.0 | 75 | 3 | 3 | — |
| 1.0 | 100 | 11 | 7b | Febrile neutropenia (n=1) |
| 1.3 | 75 | 11 | 10c | Grade 3 bone pain (n=1) |
| 1.5 | 75 | 16 | 6d | Febrile neutropenia (n=1) |
| 1.3 | 100 | 4 | 4 | Febrile neutropenia (n=2) |
| Total | 48 | 33 |
MTD=maximum tolerated dose; DLT=dose-limiting toxicity.
a
The MTD-evaluable population included all patients in the dose-escalation phase with sufficient safety assessments during cycle 1 to determine whether a DLT occurred.
b
Three patients did not complete cycle 1 of treatment, and one patient was excluded due to pre-existing peripheral neuropathy.
c
One patient had study drug held in cycle 1 and was not used in the determination of MTD.
d
Ten additional patients enrolled following determination of dose level as MTD.