To date, we have treated 51 patients (pts.) on an ongoing multicenter phase II study of botezomib in pts. with indolent NHL and mantle cell lymphoma (MCL). The average number of cycles received per patient was four. This includes 19 patients with follicular lymphoma (FL), 23 with MCL, 5 with small lymphocytic lymphoma-CLL type; and 4 with marginal zone lymphoma (MZL). All patients were required to sign an informed consent and have adequate hematologic counts (i.e. an ANC of > 1500 cells/ml and a platelet count > 50,000/ml). All but one patient had received some form of treatment prior to receiving bortezomib, including: CHOP +/− R (60%); CVP +/− R (20%); or some other purine analog based treatment program (15%). Patients were treated at a dose of 1.5 mg/m2 on Days 1, 4, 8 and 11 every 21 days. No Grade IV toxicities were noted, and the most common Grade 3 toxicity was lymphopenia. Three pts. experienced grade 3 sensory neuropathy. Re-staging studies were routinely performed every two cycles. The overall response rate was 55%, though there is considerable variability among the subtypes both in the response rate, and time to response. One of 5 pts. with SLL experienced a partial remission, in contrast to all 4 patients with marginal zone lymphoma who experienced a partial remission. In most of these latter cases, patients experienced tumor shrinkage after 2 to 4 doses. While all pts. are in active follow-up, one has sustained the response in excess of 10+ months, the other in excess of 18+ months. Of 23 pts. with MCL, the response rate among the evaluable pts. is 56%. While most of these pts. are in active follow-up, the shortest duration of remission was 6 months, the longest 19 months. Patients typically responded by the second cycle, or didn’t respond. Two patients have received 3 additional courses of therapy, achieving a PR on each re-treatment. In FL the response rate is 60%, including one CR and one Cru. These pts. responded later in treatment, typically after the third cycle and later. To date, the median duration of response has not been reached. These data continue to support the activity of bortezomib in pts. with select sub-types of NHL, and raise the merits of potential re-treatment in responding pts.

Topics:
bortezomib, lymphoma, non-hodgkin, multicatalytic endopeptidase complex, brachial plexus neuritis, follow-up, marginal zone b-cell lymphoma, partial response, toxic effect, cyclophosphamide, doxorubicin, prednisone, and vincristine, disease remission

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2005, The American Society of Hematology
2004
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