本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2400712

摘要内容如下：

背景

硼替佐米、来那度胺和地塞米松（VRD）是新诊断多发性骨髓瘤患者的首选一线治疗方案。在VRD方案中加入抗CD38单克隆抗体伊沙妥昔单抗是否会降低不适合接受移植的患者的疾病进展或死亡风险尚不清楚。

方法

在一项国际、开放标签、3期临床试验中，我们以3:2的比例将年龄在18至80岁、不适合接受移植的新诊断多发性骨髓瘤患者随机分配接受伊沙妥昔单抗联合VRD或单独接受VRD。主要疗效终点是无进展生存期。关键的次要终点包括完全缓解或更好以及完全缓解患者的微小残留病（MRD）阴性状态。

结果

共有446名患者接受了随机分组。在中位59.7个月的随访中，伊沙妥昔单抗-VRD组估计的60个月无进展生存率为63.2%，而VRD组为45.2%（疾病进展或死亡的风险比为0.60；98.5%置信区间，0.41至0.88；P<0.001）。伊沙妥昔单抗-VRD组完全缓解或更好的患者百分比显著高于VRD组（74.7%vs.64.1%，P=0.01），MRD阴性和完全缓解的患者百分比也是如此（55.5%vs.40.9%，P=0.00 3）。伊沙妥昔单抗-VRD方案未观察到新的安全性信号。两组治疗期间严重不良事件发生率和导致停药的不良事件发生率相似。

结论

伊沙妥昔单抗-VRD作为18至80岁新诊断的多发性骨髓瘤患者的初始治疗比VRD更有效，这些患者不适合接受移植。（由赛诺菲（Sanofi）和一家癌症中心资助；IMROZ ClinicalTrials.gov，NCT03319667）。

英文原文如下：

Abstracts

BACKGROUND  Bortezomib, lenalidomide, and dexamethasone (VRd) is a preferred first-line treatment option for patients with newly diagnosed multiple myeloma. Whether the addition of the anti-CD38 monoclonal antibody isatuximab to the VRd regimen would reduce the risk of disease progression or death among patients ineligible to undergo transplantation is unclear.

METHODS  In an international, open-label, phase 3 trial, we randomly assigned, in a 3:2 ratio, patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation to receive either isatuximab plus VRd or VRd alone. The primary efficacy end point was progression-free survival. Key secondary end points included a complete response or better and minimal residual disease (MRD)-negative status in patients with a complete response.

RESULTS  A total of 446 patients underwent randomization. At a median follow-up of 59.7 months, the estimated progression-free survival at 60 months was 63.2% in the isatuximab-VRd group, as compared with 45.2% in the VRd group (hazard ratio for disease progression or death, 0.60; 98.5% confidence interval, 0.41 to 0.88; P<0.001). The percentage of patients with a complete response or better was significantly higher in the isatuximab-VRd group than in the VRd group (74.7% vs. 64.1%, P = 0.01), as was the percentage of patients with MRD-negative status and a complete response (55.5% vs. 40.9%, P = 0.003). No new safety signals were observed with the isatuximab-VRd regimen. The incidence of serious adverse events during treatment and the incidence of adverse events leading to discontinuation were similar in the two groups.

CONCLUSIONS  Isatuximab-VRd was more effective than VRd as initial therapy in patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation. (Funded by Sanofi and a Cancer Center Support Grant; IMROZ ClinicalTrials.gov number, NCT03319667.).

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