关键词: Antibodies Drug Therapy Hematology Monoclonal Progression-Free Survival

Mesh : Humans Antibodies, Monoclonal Antineoplastic Combined Chemotherapy Protocols / therapeutic use Bortezomib / therapeutic use Dexamethasone / therapeutic use Disease Progression Lenalidomide / therapeutic use Multiple Myeloma / therapy Progression-Free Survival Aged Clinical Trials as Topic

来  源:   DOI:10.1016/j.clml.2023.09.003

Abstract:
Daratumumab, lenalidomide and dexamethasone (DRd) and bortezomib, lenalidomide and dexamethasone (VRd) are preferred regimens for transplant ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM). Both DRd and VRd demonstrated superior efficacy versus Rd in the MAIA and SWOG S0777 trials, respectively, but there is no head-to-head (H2H) clinical trial comparing their efficacy. Differing populations in the MAIA and S0777 trials make an unadjusted comparison of outcomes challenging and biased. The current TAURUS study is the first real-world H2H study comparing progression-free survival (PFS) among TIE NDMM patients treated with DRd or VRd as first-line (1L) in similar clinical settings.
A multicenter chart review study was conducted at nine sites across the United States. All TIE patients treated with DRd and a randomly selected population of VRd patients were included. TIE NDMM patients aged ≥65 were included if they initiated 1L DRd/VRd between January 2019 and September 2021. PFS was defined as the time from DRd/VRd initiation until disease progression or death. A doubly-robust multivariable Cox regression model combined with inverse probability of treatment weighting (IPTW) methodology was used to compare PFS between cohorts.
Weighted cohorts comprised 91 DRd and 87 VRd patients. Thirteen DRd and 24 VRd patients experienced progression/death. Patients treated with DRd had a lower risk of progression/death versus VRd (adjusted hazard ratio: 0.35, 95% confidence interval: [0.17; 0.73]).
DRd is associated with a significantly lower risk of disease progression or death compared to VRd as 1L treatment for TIE NDMM patients.
摘要:
背景:Daratumumab,来那度胺和地塞米松(DRd)和硼替佐米,来那度胺和地塞米松(VRd)是新诊断多发性骨髓瘤(NDMM)移植不合格(TIE)患者的首选方案.在MAIA和SWOGS0777试验中,DRd和VRd均表现出优于Rd的疗效,分别,但没有头对头(H2H)临床试验比较其疗效。MAIA和S0777试验中的不同人群使结果的未经调整的比较具有挑战性和偏见。当前的TAURUS研究是第一个真实世界的H2H研究,比较了在类似临床环境中以DRd或VRd作为一线(1L)治疗的TIENDMM患者的无进展生存期(PFS)。
方法:在美国9个地点进行了一项多中心图表综述研究。包括所有接受DRd治疗的TIE患者和随机选择的VRd患者群体。如果年龄≥65岁的TIENDMM患者在2019年1月至2021年9月之间开始1LDRd/VRd,则包括在内。PFS定义为从DRd/VRd开始到疾病进展或死亡的时间。使用双重稳健的多变量Cox回归模型结合治疗加权逆概率(IPTW)方法来比较队列之间的PFS。
结果:加权队列包括91名DRd和87名VRd患者。13名DRd和24名VRd患者出现进展/死亡。与VRd相比,接受DRd治疗的患者的进展/死亡风险较低(调整后的风险比:0.35,95%置信区间:[0.17;0.73])。
结论:与VRd作为1L治疗TIENDMM患者相比,DRd与疾病进展或死亡的风险显著降低相关。
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