title: Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study.
abstract: 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.
authors.affiliation: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN;
authors.forename: Ian W
authors.initials: IW
authors.lastname: Flinn
authors.forename: Richard
authors.initials: R
authors.lastname: van der Jagt
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.forename: Peter
authors.initials: P
authors.lastname: Wood
authors.forename: Tim E
authors.initials: TE
authors.lastname: Hawkins
authors.forename: David
authors.initials: D
authors.lastname: Macdonald
authors.forename: Mark
authors.initials: M
authors.lastname: Hertzberg
authors.forename: Yiu-Lam
authors.initials: YL
authors.lastname: Kwan
authors.forename: David
authors.initials: D
authors.lastname: Simpson
authors.forename: Michael
authors.initials: M
authors.lastname: Craig
authors.forename: Kathryn
authors.initials: K
authors.lastname: Kolibaba
authors.forename: Samar
authors.initials: S
authors.lastname: Issa
authors.forename: Regina
authors.initials: R
authors.lastname: Clementi
authors.forename: Doreen M
authors.initials: DM
authors.lastname: Hallman
authors.forename: Mihaela
authors.initials: M
authors.lastname: Munteanu
authors.forename: Ling
authors.initials: L
authors.lastname: Chen
authors.forename: John M
authors.initials: JM
authors.lastname: Burke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000505:Alopecia / Q000139:chemically induced; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010292:Paresthesia / Q000139:chemically induced; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D000069283:Rituximab; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069461:Bendamustine Hydrochloride; D011241:Prednisone