Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: The BRIGHT study

Ian W. Flinn, Richard Van Der Jagt, Brad S. Kahl, Peter Wood, Tim E. Hawkins, David MacDonald, Mark Hertzberg, Yiu Lam Kwan, David Simpson, Michael Craig, Kathryn Kolibaba, Samar Issa, Regina Clementi, Doreen M. Hallman, Mihaela Munteanu, Ling Chen, John M. Burke

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402 Scopus citations

Abstract

This randomized, noninferiority (NI), global, phase 3 study evaluated the efficacy and safety ofbendamustineplusrituximab(BR) vs a standard rituximab-chemotherapy regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] or rituximab plus cyclophosphamide, vincristine, and prednisone [R-CVP]) for treatmentnaive patients with indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Investigators preassigned the standard treatment regimen they considered most appropriate for each patient; patients were randomized to receive BR (n 5 224) or standard therapy (R-CHOP/R-CVP, n 5 223) for 6 cycles; 2 additional cycles were permitted at investigator discretion. Response was assessed by a blinded independent review committee. BR was noninferior to R-CHOP/R-CVP, as assessed by the primary end point of complete response rate (31% vs 25%, respectively; P 5 .0225 for NI [0.88 margin]). The overall response rates for BR and R-CHOP/R-CVP were 97% and 91%, respectively (P 5 .0102). Incidences of vomiting and drug-hypersensitivity reactions were significantly higher in patients treated with BR (P < .05), and incidences of peripheral neuropathy/paresthesia and alopecia were significantly higher in patients treated with standard-therapy regimens (P < .05). These data indicate BR is noninferior to standard therapy with regard to clinical response with an acceptable safety profile.

Original languageEnglish
Pages (from-to)2944-2952
Number of pages9
JournalBlood
Volume123
Issue number19
DOIs
StatePublished - May 8 2014

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