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

• Published in: Blood Vol. 123; no. 19; pp. 2944 - 2952
• Main Authors: Flinn, Ian W., van der Jagt, Richard, Kahl, Brad S., Wood, Peter, Hawkins, Tim E., MacDonald, David, Hertzberg, Mark, Kwan, Yiu-Lam, Simpson, David, Craig, Michael, Kolibaba, Kathryn, Issa, Samar, Clementi, Regina, Hallman, Doreen M., Munteanu, Mihaela, Chen, Ling, Burke, John M.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 08.05.2014; American Society of Hematology
• Subjects: Adult; Aged; Aged, 80 and over; Alopecia - chemically induced; Antibodies, Monoclonal, Murine-Derived - administration & dosage; Antibodies, Monoclonal, Murine-Derived - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bendamustine Hydrochloride; Clinical Trials and Observations; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Drug Administration Schedule; Fatigue - chemically induced; Female; Humans; Lymphoma, Mantle-Cell - drug therapy; Lymphoma, Non-Hodgkin - drug therapy; Male; Middle Aged; Nausea - chemically induced; Nitrogen Mustard Compounds - administration & dosage; Nitrogen Mustard Compounds - adverse effects; Paresthesia - chemically induced; Peripheral Nervous System Diseases - chemically induced; Prednisone - administration & dosage; Prednisone - adverse effects; Rituximab; Treatment Outcome; Vincristine - administration & dosage; Vincristine - adverse effects; Vomiting - chemically induced
• ISSN: 0006-4971; 1528-0020; 1528-0020
• DOI: 10.1182/blood-2013-11-531327

This randomized, noninferiority (NI), global, phase 3 study evaluated the efficacy and safety of bendamustine plus rituximab (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 treatment-naive 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 = 224) or standard therapy (R-CHOP/R-CVP, n = 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 = .0225 for NI [0.88 margin]). The overall response rates for BR and R-CHOP/R-CVP were 97% and 91%, respectively (P = .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. This trial was registered at www.clinicaltrials.gov as #NCT00877006. •The complete response rate for first-line bendamustine/rituximab was statistically noninferior to R-CHOP or R-CVP in indolent NHL or MCL.•The safety profile of bendamustine/rituximab is distinct from that of R-CHOP/R-CVP.