文章：

Venetoclax联合方案可延缓不适合强化治疗的急性髓系白血病患者健康相关生活质量的恶化时间

Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia

原文发布日期：2022-04-20

DOI: 10.1038/s41408-022-00668-8

类型: Article

开放获取: 是

英文摘要：

Phase 3 trials Viale-A and Viale-C evaluated health-related quality of life (HRQoL) in patients with AML unfit for intensive chemotherapy who received venetoclax (VEN) + (AZA) (Viale-A) or low-dose cytarabine (LDAC) (Viale-C) or placebo (PBO) + AZA or LDAC. Patient-reported outcomes included: EORTC QLQ-C30 global health status (GHS/QoL) and physical functioning (PF), PROMIS Cancer Fatigue Short Form 7a (Fatigue), and EQ-5D-5L health status visual analog scale (HS-VAS). Time to deterioration (TTD), defined as worsening from baseline in meaningful change thresholds (MCT) of ≥10, 5, or 7 points for GHS/QoL or PF, fatigue, and HS-VAS, respectively, was assessed; differences between groups were analyzed using Kaplan-Meier and unadjusted log-rank analyses. VEN + AZA vs PBO + AZA patients had longer TTD in GHS/QoL (P = 0.066) and fatigue (P = 0.189), and significantly longer TTD in PF (P = 0.028) and HS-VAS (P < 0.001). VEN + LDAC vs PBO + LDAC patients had significantly longer TTD in GHS/QoL (P = 0.011), PF (P = 0.020), and fatigue (P = 0.004), and a trend in HS-VAS (P = 0.057). Approximately 43%, 35%, 32%, and 18% of patients treated with VEN + AZA, AZA + PBO, VEN + LDAC, or LDAC + PBO, respectively, saw improvements >MCT in GHS/QoL. Overall, VEN may positively impact HRQoL in patients with AML ineligible for intensive chemotherapy, leading to longer preservation of functioning and overall health status.
 

摘要翻译： 

三期临床试验Viale-A和Viale-C评估了不适合强化化疗的急性髓系白血病患者在接受维奈克拉联合阿扎胞苷（Viale-A研究）或小剂量阿糖胞苷（Viale-C研究）或相应安慰剂联合治疗时的健康相关生活质量。患者报告结局包括：EORTC QLQ-C30总体健康状态/生活质量、躯体功能、PROMIS癌症疲劳简表7a评分以及EQ-5D-5L健康状态视觉模拟量表。研究评估了至恶化时间（定义为较基线下降达到最小临床重要差值阈值：总体健康状态/生活质量和躯体功能≥10分、疲劳≥5分、健康状态视觉模拟量表≥7分），并采用Kaplan-Meier法和未校正对数秩检验分析组间差异。结果显示，维奈克拉联合阿扎胞苷组较安慰剂联合阿扎胞苷组在总体健康状态/生活质量（P=0.066）和疲劳（P=0.189）方面呈现更长的至恶化时间趋势，在躯体功能（P=0.028）和健康状态视觉模拟量表（P<0.001）方面则显著延长。维奈克拉联合小剂量阿糖胞苷组较安慰剂联合小剂量阿糖胞苷组在总体健康状态/生活质量（P=0.011）、躯体功能（P=0.020）及疲劳（P=0.004）方面均显著延长至恶化时间，健康状态视觉模拟量表也呈现改善趋势（P=0.057）。在总体健康状态/生活质量改善超过最小临床重要差值的患者比例方面，维奈克拉联合阿扎胞苷组、阿扎胞苷联合安慰剂组、维奈克拉联合小剂量阿糖胞苷组及小剂量阿糖胞苷联合安慰剂组分别约为43%、35%、32%和18%。总体而言，维奈克拉可能对不适合强化化疗的急性髓系白血病患者健康相关生活质量产生积极影响，有助于延长功能状态和整体健康水平的维持时间。

原文链接：

Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia