A phase II study, led by Andre Goy, of the University of Texas M.D. Anderson Cancer Center, Houston, evaluated efficacy and toxicity of Bortezomib ( Velcade ) in 60 patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
The patients were stratified into arm A ( mantle-cell lymphoma ) or arm B ( other B-cell lymphomas ) without limitation in number of prior therapies.
Bortezomib was administered as an intravenous push ( 1.5 mg/m2 ) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.
The results included:
In the mantle cell lymphoma group, 12 of 29 ( 41 percent ) evaluable patients responded to Bortezomib treatment. Specifically:
- six patients achieved complete responses;
- six patients achieved partial responses;
- approximately 80 percent of patients retained their response at six months;
- the median time to progression has not been reached with a median follow-up of 9.3 months.
In the B-cell lymphoma group, 4 of 21 ( 19 percent ) evaluable B-cell lymphoma patients responded to Bortezomib treatment with a median of two cycles of therapy administered.
This patient population was heavily pre-treated, and had received an average of four prior therapies ( with a range of one to 12 ).
Grade 3 toxicity included thrombocytopenia ( 47% ), gastrointestinal ( 20% ), fatigue ( 13% ), neutropenia ( 10% ), and peripheral neuropathy ( 5% ).
Grade 4 toxicity occurred in nine patients ( 15% ), and three deaths from progression of disease occurred within 30 days of withdrawal from study.
Bortezomib showed promising activity in relapsed mantle-cell lymphoma and encouraging results in other B-cell lymphomas.
Source: Journal of Clinical Oncology, 2005