根据患者特征分析每周一次与每周两次卡非佐米治疗复发难治多发性骨髓瘤的疗效:III期A.R.R.O.W.研究亚组分析
Once- versus twice-weekly carfilzomib in relapsed and refractory multiple myeloma by select patient characteristics: phase 3 A.R.R.O.W. study subgroup analysis
原文发布日期:2020-03-09
DOI: 10.1038/s41408-020-0300-y
类型: Article
开放获取: 是
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The phase 3 A.R.R.O.W. study demonstrated that treatment with once-weekly carfilzomib (70 mg/m2) and dexamethasone (once-weekly Kd70 mg/m2) improved progression-free survival compared with twice-weekly carfilzomib (27 mg/m2) and dexamethasone (twice-weekly Kd27 mg/m2) in patients with relapsed and refractory multiple myeloma (RRMM; median, 11.2 versus 7.6 months; hazard ratio [HR] = 0.69; 95% confidence interval, 0.54–0.88; P = 0.0029). Once-weekly dosing also improved response rates and depth of response. We performed a subgroup analysis from A.R.R.O.W. according to age (<65, 65–74, or ≥75 years), renal function (creatinine clearance <50, ≥50–<80, or ≥80 mL/min), number of prior therapies (2 or 3), and bortezomib-refractory status (yes or no). Compared with twice-weekly Kd27 mg/m2, once-weekly Kd70 mg/m2 reduced the risk of progression or death (HR = 0.60–0.85) and increased overall response rates in nearly all the examined subgroups, consistent with reports in the overall A.R.R.O.W. population. The safety profiles of once-weekly Kd70 mg/m2 across subgroups were also generally consistent with those in the overall population. Findings from this subgroup analysis generally demonstrate a favorable benefit–risk profile of once-weekly Kd70 mg/m2, further supporting once-weekly carfilzomib dosing as an appropriate treatment option for patients with RRMM, regardless of baseline patient and disease characteristics.
三期A.R.R.O.W.研究显示,在复发难治性多发性骨髓瘤患者中,与每周两次卡非佐米联合地塞米松方案相比,每周一次卡非佐米联合地塞米松方案能显著改善无进展生存期。具体数据为:中位无进展生存期11.2个月对7.6个月,风险比0.69,95%置信区间0.54-0.88,P=0.0029。每周一次给药方案同时还提升了缓解率和缓解深度。我们根据年龄、肾功能、既往治疗线数及硼替佐米难治状态对A.R.R.O.W.研究进行了亚组分析。结果显示在所有分析的亚组中,每周一次方案均能降低疾病进展或死亡风险,并提高总体缓解率,这一趋势与总体人群报告一致。各亚组中每周一次方案的安全性与总体人群基本一致。本亚组分析结果表明每周一次方案具有理想的获益-风险特征,进一步支持该方案可作为不同基线特征RRMM患者的合适治疗选择。
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