文章：

VIALE-C研究的6个月随访显示，对于不适合强化化疗的初治急性髓系白血病患者，其疗效更佳且持久

6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy

原文发布日期：2021-10-01

DOI: 10.1038/s41408-021-00555-8

类型: Article

开放获取: 是

英文摘要：

VIALE-C compared the safety and efficacy of venetoclax or placebo plus low-dose cytarabine (+LDAC) in patients with untreated AML ineligible for intensive chemotherapy. Overall, 211 patients were enrolled (n = 143, venetoclax; n = 68, placebo). At the primary analysis, the study did not meet its primary endpoint of a statistically significant improvement in overall survival (OS), however, ~60% of patients had been on study for ≤6-months. Here, we present an additional 6-months of follow-up of VIALE-C (median follow-up 17.5 months; range 0.1–23.5). Median OS was (venetoclax +LDAC vs. placebo +LDAC) 8.4 vs. 4.1 months (HR = 0.70, 95% CI 0.50,0.99; P = 0.040); a 30% reduction in the risk of death with venetoclax. Complete response (CR)/CR with incomplete hematologic recovery (CRi) rates were 48.3% vs. 13.2%. Transfusion independence rates (RBC) were 43% vs.19% and median event-free survival was 4.9 vs. 2.1 months (HR = 0.61; 95% CI 0.44,0.84; P = 0.002). These results represent improved efficacy over the primary analysis. Incidence of grade ≥3 adverse events were similar between study arms and overall safety profiles were comparable to the primary analysis. These data support venetoclax +LDAC as a frontline treatment option for patients with AML ineligible for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.
 

摘要翻译： 

VIALE-C研究比较了维奈托克或安慰剂联合低剂量阿糖胞苷（+LDAC）在不适合强化化疗的初治急性髓系白血病患者中的安全性和有效性。共计211例患者入组（维奈托克组n=143；安慰剂组n=68）。在初步分析时，该研究未达到总生存期（OS）统计学显著改善的主要终点，但约60%的患者在研时间≤6个月。本文报告VIALE-C研究额外6个月的随访结果（中位随访时间17.5个月；范围0.1–23.5）。维奈托克+LDAC组与安慰剂+LDAC组的中位OS分别为8.4个月 vs. 4.1个月（HR=0.70，95% CI 0.50–0.99；P=0.040），维奈托克治疗使死亡风险降低30%。完全缓解（CR）/血细胞计数不完全恢复的完全缓解（CRi）率为48.3% vs. 13.2%。红细胞输注不依赖率为43% vs. 19%，中位无事件生存期为4.9个月 vs. 2.1个月（HR=0.61；95% CI 0.44–0.84；P=0.002）。这些结果显示出较初步分析更优的疗效。两组≥3级不良事件发生率相近，总体安全性与初步分析一致。这些数据支持维奈托克+LDAC作为不适合强化化疗的AML患者的一线治疗选择。本试验在ClinicalTrials.gov注册号为NCT03069352。

原文链接：

6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy