Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study
Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study
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DOI：
10.1182/blood-2013-11-531327
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发表时间：
2014-05-08
期刊：
影响因子：
20.3
通讯作者：
Burke, John M.
中科院分区：
文献类型：
--
作者：
Flinn, Ian W.;van der Jagt, Richard;Burke, John M.
这项随机、非劣效性（NI）的全球3期研究评估了苯达莫司汀联合利妥昔单抗（BR）对比标准的利妥昔单抗化疗方案（利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松[R - CHOP]或利妥昔单抗联合环磷酰胺、长春新碱和泼尼松[R - CVP]）在初治的惰性非霍奇金淋巴瘤或套细胞淋巴瘤患者中的疗效和安全性。研究者预先指定他们认为对每位患者最合适的标准治疗方案；患者随机接受BR（n = 224）或标准治疗（R - CHOP/R - CVP，n = 223），共6个周期；研究者可自行决定是否允许额外增加2个周期。由一个盲态的独立评审委员会评估疗效。通过主要终点完全缓解率评估，BR不劣于R - CHOP/R - CVP（分别为31%对25%；非劣效性[0.88界值]的P = 0.0225）。BR和R - CHOP/R - CVP的总体缓解率分别为97%和91%（P = 0.0102）。BR治疗的患者中呕吐和药物过敏反应的发生率显著更高（P < 0.05），标准治疗方案治疗的患者中外周神经病变/感觉异常和脱发的发生率显著更高（P < 0.05）。这些数据表明，就临床疗效而言，BR不劣于标准治疗，且安全性可接受。该试验在www.clinicaltrials.gov注册，注册号为#NCT00877006。
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.