Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 172, Issue 2, Pages 208-218Publisher
WILEY
DOI: 10.1111/bjh.13818
Keywords
lymphoma; chemotherapy; mantle cell lymphoma; maintenance therapy; proteasome inhibition
Categories
Funding
- PHS/DHHS by National Cancer Institute (NCI), National Clinical Trials Network (NCTN) [CA180888, CA180819, CA180834, CA180818]
- NCI Community Oncology Research Program (NCORP) [CA189830, CA189858, CA189808, CA189860, CA189957, CA189872, CA189953, CA189954, CA189804]
- NIH/NCI [CA11083, CA35119]
- Millennium Pharmaceuticals, Inc.
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Bortezomib is active in mantle cell lymphoma (MCL), with approval in upfront and relapsed settings. Given inevitable recurrence following induction chemoimmunotherapy, maintenance approaches are a rational strategy to improve clinical outcomes. We conducted a phase II study to evaluate the safety and efficacy of six cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) plus bortezomib (13mg/m(2) days 1 and 4 of 21d cycles) followed by bortezomib maintenance (13mg/m(2) days 1, 4, 8, and 11 every 3months for 2years). Sixty-five eligible patients were enrolled. The treatment was well tolerated and toxicities were mainly haematological. The rate of grade 3 peripheral neuropathy was low (5%). With a median follow-up of 68years, 2-year progression-free survival (PFS) was 62%, and 2-year overall survival (OS) was 85%. At 5years, PFS was 28% and OS was 66%. MCL International Prognostic Index scores were significantly associated with 2-year PFS, but did not predict long-term (5-year) PFS. Baseline Ki-67 index was significantly associated with survival. Combination R-CHOP with bortezomib followed by maintenance bortezomib appears to improve outcomes compared historically with R-CHOP alone, with prolonged remissions in a subset of patients. These results suggest that inclusion of bortezomib with induction chemotherapy and/or maintenance is promising in MCL and warrants further exploration.
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