Kumar Shaji, Fu Alan, Niesvizky Ruben, Jagannath Sundar, Boccia Ralph, Raje Noopur
Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Center for Observational Research, Amgen Inc, Thousand Oaks, CA.
Blood Adv. 2021 Jan 26;5(2):367-376. doi: 10.1182/bloodadvances.2019001059.
In the phase 3 ENDEAVOR study, carfilzomib-dexamethasone (Kd) improved survival over bortezomib-dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (RRMM), regardless of baseline renal function. This real-world study compared renal response in patients with RRMM (1-3 prior lines) and renal impairment (estimated glomerular filtration rate ≤50 mL/min) treated with Kd vs Vd. Electronic medical records data from the Oncology Services Comprehensive Electronic Records database were assessed (from January 2012 through February 2018). Time to renal response (defined according to International Myeloma Working Group criteria) was evaluated using the Kaplan-Meier method and log-rank test. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated for renal overall response (ROR) and renal complete response (RCR) using Cox proportional hazard models adjusted for baseline covariates. Included were 543 Kd-treated and 1005 Vd-treated patients. In line 2 (2L), compared with Vd, Kd achieved significantly higher ROR (51.4% vs 39.6%; P < .0001) and RCR (26.6% vs 22.2%; P = .0229). After baseline covariate adjustment, 2L patients receiving Kd vs Vd were 45% more likely to achieve ROR (IRR, 1.45; 95% CI, 1.18-1.78), and 68% were more likely to achieve RCR (IRR, 1.68; 95% CI, 1.24-2.28). The renal response benefit with Kd remained consistent in 2L to line 4 (4L). In a combined analysis of patients receiving Kd and Vd (2L and 2L-4L), renal responders had longer overall survival and time to next treatment than renal nonresponders. These results demonstrate improved real-world effectiveness of Kd over Vd in RRMM renal rescue, and the positive association between renal response and improved survival.
在3期ENDEAVOR研究中，对于复发或难治性多发性骨髓瘤（RRMM）患者，无论基线肾功能如何，卡非佐米-地塞米松（Kd）方案相较于硼替佐米-地塞米松（Vd）方案可改善生存情况。这项真实世界研究比较了接受Kd和Vd治疗的RRMM患者（既往接受过1-3线治疗）及肾功能损害（估计肾小球滤过率≤50 mL/分钟）患者的肾脏反应。评估了肿瘤服务综合电子记录数据库（2012年1月至2018年2月）中的电子病历数据。使用Kaplan-Meier方法和对数秩检验评估达到肾脏反应的时间（根据国际骨髓瘤工作组标准定义）。使用针对基线协变量进行调整的Cox比例风险模型计算肾脏总体缓解（ROR）和肾脏完全缓解（RCR）的发病率比（IRR）和95%置信区间（CI）。纳入了543例接受Kd治疗的患者和1005例接受Vd治疗的患者。在二线（2L）治疗中，与Vd相比，Kd的ROR显著更高（51.4%对39.6%；P <.0001），RCR也更高（26.6%对22.2%；P =.0229）。在对基线协变量进行调整后，接受Kd治疗的2L患者与接受Vd治疗的患者相比，实现ROR的可能性高45%（IRR，1.45；95%CI，1.18-1.78），实现RCR的可能性高68%（IRR，1.68；95%CI，1.24-2.28）。Kd的肾脏反应获益在2L至四线（4L）治疗中保持一致。在对接受Kd和Vd治疗的患者（2L和2L-4L）进行的综合分析中，肾脏反应者的总生存期和至下次治疗时间比无肾脏反应者更长
