TY - JOUR
T1 - Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL
T2 - The BRIGHT study
AU - Flinn, Ian W.
AU - Van Der Jagt, Richard
AU - Kahl, Brad S.
AU - Wood, Peter
AU - Hawkins, Tim E.
AU - MacDonald, David
AU - Hertzberg, Mark
AU - Kwan, Yiu Lam
AU - Simpson, David
AU - Craig, Michael
AU - Kolibaba, Kathryn
AU - Issa, Samar
AU - Clementi, Regina
AU - Hallman, Doreen M.
AU - Munteanu, Mihaela
AU - Chen, Ling
AU - Burke, John M.
PY - 2014/5/8
Y1 - 2014/5/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84900423736&partnerID=8YFLogxK
U2 - 10.1182/blood-2013-11-531327
DO - 10.1182/blood-2013-11-531327
M3 - Article
C2 - 24591201
AN - SCOPUS:84900423736
SN - 0006-4971
VL - 123
SP - 2944
EP - 2952
JO - Blood
JF - Blood
IS - 19
ER -