BENDAMUSTINE RELOADED

Blood. 2011 Jan 14. [Epub ahead of print]

The combination of bendamustine, bortezomib and rituximab for patients with relapsed/refractory indolent and mantle cell non-Hodgkin lymphoma.

Friedberg JW, Vose JM, Kelly JL, Young F, Bernstein SH, Peterson D, Rich L, Blumel S, Proia NK, Liesveld J, Fisher RI, Armitage JO, Grant S, Leonard JP.

James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, United States;

Abstract

Given the significant activity and tolerability of the bendamustine, rituximab and bortezomib in patients with relapsed indolent and mantle cell non-Hodgkin's lymphoma (NHL), and laboratory studies suggesting synergistic activity, we conducted a multicenter phase II study of the bendamustine/bortezomib/rituximab combination. Patients with relapsed or refractory indolent and mantle cell lymphoma with adequate organ function were treated with bendamustine 90 mg/m2 day 1 and day 4; rituximab 375 mg/m2 day 1, and bortezomib 1.3 mg/m2 day 1, 4, 8, 11. Six 28-day cycles were planned. Thirty patients (7 with mantle cell lymphoma) were enrolled and treated. Eight patients experienced serious adverse events including one grade 5 sepsis event. Common non-hematologic adverse events were generally grade 1 or grade 2 and included nausea (50%), neuropathy (47%), fatigue (47%), constipation (40%), and fever (40%). Of 29 patients evaluable for efficacy, 24 (83%) achieved an objective response (including 15 with complete response). With median follow-up of 24 months, 2 year PFS is 47% (95% CI: 25-69%). Based upon these promising results, the United States cooperative groups have initiated randomized trials evaluating this regimen in follicular and mantle cell lymphoma. This trial was registered at www.clinicaltrials.gov as #NCT00547534.