Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
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DOI：
10.1056/nejmoa1714678
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发表时间：
2018-02-08
影响因子：
158.5
通讯作者：
San-Miguel, J.
中科院分区：
文献类型：
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作者：
Mateos, M. -V.;Dimopoulos, M. A.;San-Miguel, J.
硼替佐米、美法仑和泼尼松联合治疗是不适合自体干细胞移植的新诊断多发性骨髓瘤患者的标准治疗方法。达雷妥尤单抗联合标准治疗方案治疗复发性或难治性多发性骨髓瘤患者已显示出疗效。METHODSIn this phase 3 trial，我们随机分配706例新诊断的多发性骨髓瘤患者，他们不符合干细胞移植的条件，接受9个周期的硼替佐米、美法仑和泼尼松单独治疗（对照组）或与达雷妥尤单抗联合治疗（达雷妥尤单抗组），直至疾病进展。主要终点是无进展生存期。在预先设定的中期分析中，中位随访时间为16.5个月，18个月无进展生存率为71.6%。达雷妥尤单抗组（95%置信区间[CI]，65.5 - 76.8）和50.2%（95%CI，43.2至56.7）（疾病进展或死亡的风险比，0.50; 95%CI，0.38至0.65; P
BACKGROUNDThe combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma.METHODSIn this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival.RESULTSAt a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P