Twice-weekly bortezomib has proven activity in mantle cell (MCL) and indolent lymphomas. This study explored a weekly schedule of bortezomib in follicular lymphoma (FL) and MCL. Although weekly bortezomib was better tolerated, the overall response rate (ORR) was inferior (18% vs. 50%, p = 0.02) with no complete remissions (CR) (compared with 18% CR for the twice-weekly schedule). Progression-free survival (PFS) was not different. The weekly schedule of bortezomib was less toxic, but yielded fewer and lower quality responses than twice-weekly bortezomib. Given the similar PFS, the weekly schedule may still be appropriate for some patients.
Patients with chemotherapy-refractory mantle cell lymphoma experience high response rates and identical progression-free survivals compared with patients with relapsed disease following treatment with single agent bortezomib: results of a multicentre phase 2 clinical trial Mantle cell lymphoma (MCL) represents an aggressive form of non-Hodgkin lymphoma. The disease often responds to initial combination chemotherapy but is characterized by inevitable relapse. In the relapsed and refractory states, the disease is characterized by partial responses with typically short durations of benefit. Most patients are treated with a cyclophosphamide-based regimen at presentation, with or without a peripheral blood stem cell transplant. Second line
SummaryThe recent approval of bortezomib for the treatment of mantle cell lymphoma (MCL) by the US Food and Drug Administration is based on the results of the multicentre PINNACLE study with supportive data from a number of single and multicentre Phase 2 studies. This multicentre Phase 2 study enroled 40 patients with heavily pretreated MCL. The overall response rate (ORR) was 47%, including 5 complete remissions and 14 partial remissions. Overall, these remissions are relatively durable. The ORR in relapsed and refractory patients was 50% and 43% respectively (P = 0AE74), while both populations of patients exhibited essentially similar progressionfree survival (PFS; 5AE6 months vs. 3AE9 months, P = 0AE81). Responding patients experienced a PFS from bortezomib that was similar to their line of prior therapy (7AE8 months vs. 8AE4 months, respectively). The data showed similar responses in relapsed and refractory patients as well as remission durations similar to prior therapy, suggesting that there may be little crossresistance with other conventional cytotoxic agents. Importantly, these data suggest that MCL patients with refractory or poorly responsive disease may still derive meaningful clinical benefit from treatment with bortezomib.
These data suggest that bortezomib has significant single agent activity in patients with FL, and that longer durations of treatment may improve overall response.
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