Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma
Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma
复制标题
DOI：
10.1056/nejmoa1412096
复制
发表时间：
2015-03-05
影响因子：
158.5
通讯作者：
Cavalli, Franco
中科院分区：
文献类型：
--
作者：
Robak, Tadeusz;Huang, Huiqiang;Cavalli, Franco
蛋白酶体抑制剂硼替佐米最初被批准用于治疗复发性mantle-cell淋巴瘤。我们研究了用R-CHOP（利妥昔单抗、环磷酰胺、阿霉素、长春新碱和强的松）替代硼替佐米是否能改善新诊断的套细胞淋巴瘤患者的预后。在这项3期试验中，我们随机分配了487名不符合或不考虑进行干细胞移植的新诊断的成年斗篷细胞淋巴瘤患者，在第1天接受6至8个21天周期的静脉注射R-CHOP（第1至5天口服泼尼松）或VR-CAP （R-CHOP方案），但在第1、4、8和11天以1.3 mg /平方米体表面积的剂量代替了新碱。主要终点为无进展生存期。结果中位随访40个月后，R-CHOP组的中位无进展生存期（根据独立放射学审查）为14.4个月，VR-CAP组为24.7个月(VR-CAP组风险比为0.63
BACKGROUNDThe proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma. We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma.METHODSIn this phase 3 trial, we randomly assigned 487 adults with newly diagnosed mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11). The primary end point was progression-free survival.RESULTSAfter a median follow-up of 40 months, median progression-free survival (according to independent radiologic review) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group (hazard ratio favoring the VR-CAP group, 0.63; P