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.

3 期试验 Viale-A 和 Viale-C 评估了接受维奈托克 (VEN) + (AZA) (Viale-A) 或低剂量阿糖胞苷 (LDAC) 的 AML 患者的健康相关生活质量 (HRQoL) ) (Viale-C) 或安慰剂 (PBO) + AZA 或 LDAC。患者报告的结果包括：EORTC QLQ-C30 全球健康状况 (GHS/QoL) 和身体机能 (PF)、PROMIS 癌症疲劳简表 7a（疲劳）和 EQ-5D-5L 健康状况视觉模拟量表（HS-VAS ）。评估恶化时间 (TTD)，定义为 GHS/QoL 或 PF、疲劳和 HS-VAS 的有意义变化阈值 (MCT) 分别从基线恶化≥10、5 或 7 点；使用 Kaplan-Meier 和未调整的对数秩分析分析组间的差异。VEN + AZA 与 PBO + AZA 患者在 GHS/QoL 中的 TTD 更长（P = 0.066) 和疲劳 ( P  = 0.189)，并且 PF ( P  = 0.028) 和 HS-VAS ( P  < 0.001) 的 TTD 显着延长。VEN + LDAC 与 PBO + LDAC 患者在 GHS/QoL ( P  = 0.011)、P F ( P  = 0.020) 和疲劳 ( P  = 0.004) 和 HS-VAS ( P  = 0.057)方面的 TTD 显着延长. 分别接受 VEN + AZA、AZA + PBO、VEN + LDAC 或 LDAC + PBO 治疗的患者中，大约 43%、35%、32% 和 18% 的 GHS/QoL 改善 > MCT。总体而言，VEN 可能对不适合强化化疗的 AML 患者的 HRQoL 产生积极影响，从而延长功能和整体健康状况的保存时间。