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• W4253107912 abstract "6581 Background: Proteasome inhibition disrupts many cell cycle checkpoints and pathways that lead to apoptosis. Preclinical and ph 1 studies suggested the proteasome inhibitor bortezomib (VELCADE™, Vc) was active in lymphoma. Methods: The primary objective of this ph 2 study was to document the response rate (RR) and toxicity of Vc in pts with relapsed or refractory NHL. Pts ≥ 16 yr, with relapsed or refractory mantle cell (MCL, gp A) or other B cell lymphomas (gp B) were eligible. Pts received Vc 1.5 mg/m2 IV on d1, 4, 8 and 11 q21d, were restaged q2 cycles, and treated for up to 6 cycles unless removed from study. Results:45 pts: 32 males, 13 females, median age 60 yr (range 45–81), were enrolled. There were 25 pts in gp A and 20 pts in gp B, including 10 diffuse large cell lymphoma (DLCL), 4 follicular lymphoma (FL), 3 transformed (t) FL, 2 small lymphocytic lymphoma (SLL), 1 Waldenström's macroglobulinemia (WM). Gp A had 3 median prior therapies (range 1–6); gp B had 4 (range 1–12). In gp A, of 21 evaluable (ev) pts, there were 11 responders: 3 CR, 1 CRu (unconfirmed CR), and 7 PR (RR = 52.3%), 2 MR, 2 no change (NC), 6 POD (progression of disease). Mean DOR (duration of response) was 5.7 mo (1.2–15 mo). In gp B, there were 8 ev DLCL with 1 PR (DOR 4 mo), 1 NC, 6 POD; 4 ev FL with 2 MR, 1 NC, 1 POD; 1 ev tFL with POD; 2 ev SLL with 1 NC, 1 POD; 1 WM pt had PR. Grade 3/4 toxicities were GI (5 pts), hypotension/fatigue (6 pts), neuropathy (1 pt with prior vinca/taxanes), and pneumonia (2 pts); hematologic toxicities were neutropenia (8) (only 1 pt with ANC <500) and thrombocytopenia (14 pt) (only 1 pt with platelets <10; most entered with platelets <30–50). 2 patients died: 1 had Cryptococcus meningitis, 1 had generalized zoster with encephalitis. Conclusions: This study showed remarkable activity of Vc in MCL and encouraging results in other B cell lymphomas. Future studies will include combinations of Vc with other chemotherapy and/or biological agents. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc." @default.
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• W4253107912 date "2004-07-15" @default.
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• W4253107912 title "Update on a phase (ph) 2 study of bortezomib in patients (pts) with relapsed or refractory indolent or aggressive non-Hodgkin's lymphomas (NHL)" @default.
• W4253107912 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.6581" @default.
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