Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study.
نویسندگان
چکیده
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.
منابع مشابه
Pharmacoeconomic Analysis of Treatment of Non- Hodgkin’s Lymphoma with Bendamustine
Hodgkin's lymphoma (NHL) are malignant lymphoproliferative diseases arising from a mutant lymphoid cell. Follicular lymphoma is the most common indolent (low-grade) NHL. No cure approach (watch and wait) is recommended for low-grade lymphomas without Bsymptoms. Mono-therapy with chlorambucil or cyclophosphamid is prescribed in case of disease progression. In NHL of high malignancy, especially w...
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whereas R-CHOP/R-CVPwas associated with increased neutropenia. BR was also associated with a slightly increased risk of opportunistic infections and nausea but decreased neuropathy and alopecia compared with R-CHOP/R-CVP. Follow-up is ongoing, and progression-free survival/overall survival data were not reported. This report by Flinn et al confirms that the future of therapy for indolent NHL an...
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Rituximab (Rituxan, Genentech/Biogen Idec Pharmaceuticals) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is currently the most widely used first-line therapy for aggressive B-cell lymphomas.1 However, many patients, including those with organ dysfunction, may not tolerate the toxicities associated with this regimen. Recent data from the phase III Study ...
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1 Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as fi rst-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet 2013; 381: 1203–10. 2 Federico M, Luminari S, Dondi A, et al. R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with ad...
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ورودعنوان ژورنال:
- Blood
دوره 123 19 شماره
صفحات -
تاریخ انتشار 2014