PDF(Pubmed)
Abstract：
UNASSIGNED: Replacement of carmustine (BCNU) in the BEAM regimen (BCNU, etoposide, cytarabine, melphalan) with bendamustine (BendaEAM) before autologous stem cell transplantation (ASCT) is feasible in lymphoma. However, randomised trials are lacking. Here, we present the first trial addressing this topic.
UNASSIGNED: This multicentre, randomised, phase 2 study (BEB-trial) conducted at four haematological centres in Austria and Switzerland compares BEAM with BendaEAM in patients with relapsed lymphoma. Both regimens were administered intravenously before ASCT, in BEAM according to the standard protocol (300 mg/m2 BCNU on day -6), in BendaEAM, BCNU was replaced by 200 mg/m2 bendamustine given on days -7 and -6. Eligible patients were aged 18-75 years and had mantle cell lymphoma, diffuse large B-cell lymphoma, or follicular lymphoma in first or second remission or chemosensitive relapse. The primary endpoint of the study was to evaluate whether replacement of BCNU by bendamustine reduces lung toxicity, defined as a decrease of the diffusion capacity of the lung for carbon monoxide by at least 20% at three months after ASCT. Data analyses were performed on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT02278796, and is complete.
UNASSIGNED: Between April 20, 2015, and November 28, 2018, 108 patients were enrolled; of whom 53 were randomly assigned to receive BendaEAM (36 male, 17 female) and 55 to receive BEAM (39 male, 16 female). All patients engrafted rapidly. Lung toxicity did not differ between groups (BendaEAM: n = 8, 19.5%; BEAM: n = 11, 25.6%; risk difference = -6.1%: 95% confidence interval: -23.9% to 11.7%). Acute toxicities of at least grade 3 were comparable in both groups (BendaEAM: 35.8%, BEAM: 30.9%). Overall survival (BendaEAM: 92.5%, BEAM: 89.1%) and complete remission (BendaEAM: 76.7%, BEAM: 74.3%) after 1 year (median follow-up: 369 days) were similar. No difference in quality of life was observed.
UNASSIGNED: Results were similar for both regimens in terms of survival and response rates. A phase 3 non-inferiority study is required to investigate whether BendaEAM can be considered as an alternative to BEAM.
UNASSIGNED: Mundipharma.
UNASSIGNED: This multicentre, randomised, phase 2 study (BEB-trial) conducted at four haematological centres in Austria and Switzerland compares BEAM with BendaEAM in patients with relapsed lymphoma. Both regimens were administered intravenously before ASCT, in BEAM according to the standard protocol (300 mg/m2 BCNU on day -6), in BendaEAM, BCNU was replaced by 200 mg/m2 bendamustine given on days -7 and -6. Eligible patients were aged 18-75 years and had mantle cell lymphoma, diffuse large B-cell lymphoma, or follicular lymphoma in first or second remission or chemosensitive relapse. The primary endpoint of the study was to evaluate whether replacement of BCNU by bendamustine reduces lung toxicity, defined as a decrease of the diffusion capacity of the lung for carbon monoxide by at least 20% at three months after ASCT. Data analyses were performed on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT02278796, and is complete.
UNASSIGNED: Between April 20, 2015, and November 28, 2018, 108 patients were enrolled; of whom 53 were randomly assigned to receive BendaEAM (36 male, 17 female) and 55 to receive BEAM (39 male, 16 female). All patients engrafted rapidly. Lung toxicity did not differ between groups (BendaEAM: n = 8, 19.5%; BEAM: n = 11, 25.6%; risk difference = -6.1%: 95% confidence interval: -23.9% to 11.7%). Acute toxicities of at least grade 3 were comparable in both groups (BendaEAM: 35.8%, BEAM: 30.9%). Overall survival (BendaEAM: 92.5%, BEAM: 89.1%) and complete remission (BendaEAM: 76.7%, BEAM: 74.3%) after 1 year (median follow-up: 369 days) were similar. No difference in quality of life was observed.
UNASSIGNED: Results were similar for both regimens in terms of survival and response rates. A phase 3 non-inferiority study is required to investigate whether BendaEAM can be considered as an alternative to BEAM.
UNASSIGNED: Mundipharma.
摘要：
■在BEAM方案中替换卡莫司汀（BCNU）（BCNU，依托泊苷,阿糖胞苷,在自体干细胞移植（ASCT）之前，美法仑）与苯达莫司汀（BendaEAM）在淋巴瘤中是可行的。然而,缺乏随机试验。这里,我们提出了解决这个主题的第一次审判。
■这个多中心，随机化，在奥地利和瑞士的4个血液学中心进行的2期研究(BEB试验)比较了复发性淋巴瘤患者的BEAM和BendaEAM.两种方案均在ASCT前静脉注射，根据标准方案在BEAM中（第-6天300mg/m2BCNU），在BendaEAM,在第-7天和第-6天给予200mg/m2苯达莫司汀替换BCNU。符合条件的患者年龄为18-75岁，患有套细胞淋巴瘤，弥漫性大B细胞淋巴瘤,或滤泡性淋巴瘤在第一次或第二次缓解或化疗敏感复发。研究的主要终点是评估苯达莫司汀替代BCNU是否能降低肺毒性，定义为ASCT后三个月肺对一氧化碳的扩散能力降低至少20％。在意向治疗的基础上进行数据分析。这项研究在ClinicalTrials.gov注册，编号NCT02278796，并已完成。
■在2015年4月20日至2018年11月28日之间，有108名患者入选；其中53名被随机分配接受BendaEAM（36名男性，17名女性）和55名接受BEAM（39名男性，16女）。所有患者移植迅速。两组之间的肺毒性没有差异（BendaEAM：n=8，19.5％；BEAM：n=11，25.6％；风险差异=-6.1％：95％置信区间：-23.9％至11.7％）。两组的急性毒性至少为3级（BendaEAM：35.8％，梁：30.9%）。总生存率（BendaEAM：92.5%，BEAM：89.1%）和完全缓解（BendaEAM：76.7%，BEAM：74.3％）1年后（中位随访：369天）相似。没有观察到生活质量的差异。
■两种方案在生存率和缓解率方面的结果相似。需要进行第3阶段非劣效性研究，以调查BendaEAM是否可以被视为BEAM的替代品。
■Mundipharma。
■这个多中心，随机化，在奥地利和瑞士的4个血液学中心进行的2期研究(BEB试验)比较了复发性淋巴瘤患者的BEAM和BendaEAM.两种方案均在ASCT前静脉注射，根据标准方案在BEAM中（第-6天300mg/m2BCNU），在BendaEAM,在第-7天和第-6天给予200mg/m2苯达莫司汀替换BCNU。符合条件的患者年龄为18-75岁，患有套细胞淋巴瘤，弥漫性大B细胞淋巴瘤,或滤泡性淋巴瘤在第一次或第二次缓解或化疗敏感复发。研究的主要终点是评估苯达莫司汀替代BCNU是否能降低肺毒性，定义为ASCT后三个月肺对一氧化碳的扩散能力降低至少20％。在意向治疗的基础上进行数据分析。这项研究在ClinicalTrials.gov注册，编号NCT02278796，并已完成。
■在2015年4月20日至2018年11月28日之间，有108名患者入选；其中53名被随机分配接受BendaEAM（36名男性，17名女性）和55名接受BEAM（39名男性，16女）。所有患者移植迅速。两组之间的肺毒性没有差异（BendaEAM：n=8，19.5％；BEAM：n=11，25.6％；风险差异=-6.1％：95％置信区间：-23.9％至11.7％）。两组的急性毒性至少为3级（BendaEAM：35.8％，梁：30.9%）。总生存率（BendaEAM：92.5%，BEAM：89.1%）和完全缓解（BendaEAM：76.7%，BEAM：74.3％）1年后（中位随访：369天）相似。没有观察到生活质量的差异。
■两种方案在生存率和缓解率方面的结果相似。需要进行第3阶段非劣效性研究，以调查BendaEAM是否可以被视为BEAM的替代品。
■Mundipharma。
