AML患者中使用Venetoclax与低甲基化剂联合治疗后缓解期细胞减少管理:基于VIALE-A真实世界经验的前后比较——来自主要美国社区环境的研究。
Post-remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre- versus post-VIALE-A real-world experience from a predominantly US community setting.
发表日期:2023 Aug 11
作者:
Pankit Vachhani, Esprit Ma, Tao Xu, Melissa Montez, Sarah Worth, Archibong Yellow-Duke, Wei-Han Cheng, Michael E Werner, Jonathan Abbas, William Donnellan
来源:
Best Pract Res Cl Ob
摘要:
这项回顾性队列研究使用一个基于电子健康记录的、去标识化的美国患者数据库,以更好地了解真实世界中venetoclax+低甲基化剂(HMAs)在常规临床护理中的治疗体验,特别是在以社区为主的设置中(患者占80.3%),以确定VIALE-A后的缓解期细胞减少管理见解是否反映在真实世界的临床实践中。患有新诊断的急性髓系白血病(AML;N=498)的患者,在AML诊断后≤30天内开始使用venetoclax+HMA,时间跨度涵盖了2018年6月1日至2021年3月31日。根据VIALE-A之前(n=330)和之后(n=168)的时期进行分层。相较于VIALE-A之前的患者(45%),VIALE-A之后的患者中有更多的人(61%)在治疗开始后的28 ± 14天内进行了第一次活组织检查。VIALE-A之后的患者骨髓(BM)评估时间早于VIALE-A之前的患者,并且对治疗反应的首次识别时间也较早(分别为2.5个月和5.1个月)。相比于VIALE-A之前的患者,VIALE-A之后的患者中更多的治疗反应者进行了venetoclax计划修改(82.1% vs 73.8%);修改的主要原因是治疗毒性,特别是细胞性减少。与未进行venetoclax计划修改相比,治疗存活结果相当。研究结果表明,venetoclax计划的修改可以用于管理细胞减少事件,而不会对治疗结果产生不利影响。还需要进一步提高骨髓评估的及早性,以确定venetoclax计划的修改,为实现最佳治疗结果提供更好的机会。© 2023 The Authors. Cancer Medicine由约翰威利父子有限公司出版。
This retrospective cohort study used an electronic health record-derived, de-identified, US patient-level database to better understand the real-world treatment experience, in a predominantly community setting (80.3% of patients), of venetoclax+hypomethylating agents (HMAs) in routine clinical care, pre- and post-VIALE-A, to determine whether the post-remission cytopenia management insight from VIALE-A was reflected in real-world clinical practice.Patients with newly diagnosed acute myeloid leukemia (AML; N = 498), who initiated venetoclax+HMA ≤30 days from AML diagnosis from June 1, 2018, to March 31, 2021, were stratified into pre-(n = 330) and post-(n = 168) VIALE-A cohorts.More patients in the post-(61%) versus pre-(45%) VIALE-A cohort had their first biopsy by 28 ± 14 days post-treatment initiation. Patients underwent bone marrow (BM) assessment earlier in the post- versus pre-VIALE-A cohort, and first identification of response was also earlier (2.5 vs 5.1 months, respectively). More venetoclax schedule modifications post-remission occurred among post-(82.1%) versus pre-(73.8%) VIALE-A responders; the most common reason for modification was treatment toxicities, specifically cytopenia. Treatment survival outcomes were comparable with or without venetoclax schedule modifications.Findings suggest that venetoclax schedule modifications can be used to manage cytopenia events without adversely affecting outcomes. Opportunities remain to improve earlier BM assessment to determine venetoclax schedule modifications, providing the best chance for optimal treatment outcomes.© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.