Dose reductions in patients receiving bortezomib and PegLD
Bortezomib dose level, mg/m2 . | Drug reduced (dose in mg/m2) . | Cycle and day* . | Reason . |
---|---|---|---|
1.05 | PegLD (to 22.5) | c4, d4 | PPE/HFS2 |
1.30† | Bortezomib (to 1.05) | c4, d1 | Decreased quality of life |
1.30† | Bortezomib (to 1.05) | c5, d1 | Peripheral neuropathy |
1.40 | Bortezomib (to 1.05) | c3, d1 | Thrombocytopenia |
1.50 | Bortezomib (to 1.30) | c3, d8 | Peripheral neuropathy |
1.50 | Bortezomib (to 1.05) | c4, d8 | Diarrhea and fatigue |
1.50 | Bortezomib (to 1.30) | c6, d8 | Diarrhea and nausea |
1.50 | Bortezomib (to 1.30) | c3, d1 | Peripheral neuropathy |
1.50 | PegLD (to 22.5) | c3, d1 | PPE/HFS |
Bortezomib dose level, mg/m2 . | Drug reduced (dose in mg/m2) . | Cycle and day* . | Reason . |
---|---|---|---|
1.05 | PegLD (to 22.5) | c4, d4 | PPE/HFS2 |
1.30† | Bortezomib (to 1.05) | c4, d1 | Decreased quality of life |
1.30† | Bortezomib (to 1.05) | c5, d1 | Peripheral neuropathy |
1.40 | Bortezomib (to 1.05) | c3, d1 | Thrombocytopenia |
1.50 | Bortezomib (to 1.30) | c3, d8 | Peripheral neuropathy |
1.50 | Bortezomib (to 1.05) | c4, d8 | Diarrhea and fatigue |
1.50 | Bortezomib (to 1.30) | c6, d8 | Diarrhea and nausea |
1.50 | Bortezomib (to 1.30) | c3, d1 | Peripheral neuropathy |
1.50 | PegLD (to 22.5) | c3, d1 | PPE/HFS |
The cycle (c) and day (d) at which reductions were pursued are indicated after the respective abbreviations. In the first case at 1.50, a patient had 2 separate bortezomib dose reductions, whereas in the last case, both bortezomib and PegLD were reduced concomitantly.
Both dose reductions at 1.30 mg/m2 occurred in the expanded cohort at this level and these data therefore did not contribute to the determination of a dose recommended for further study.