Venetoclax 联合 FLAG-IDA 治疗难治或复发急性髓性白血病

IF 2.3 3区 医学 Q2 HEMATOLOGY
Kai Wille, Marvin Dumke, Nadine Wilsdorf, Parvis Sadjadian, Artur Schneider, Stephanie Jender-Bartling, Vera Kolatzki, Anette Horstmann, Raphael Meixner, Marina Jiménez-Muñoz, Christiane Fuchs, Hans-Joachim Tischler, Martin Griesshammer
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引用次数: 0

摘要

导言难治或复发急性髓细胞性白血病(R/R-AML)患者的预后非常有限。为了(重新)获得完全缓解,最近有越来越多的证据表明,将 Venetoclax(VEN)与化疗联合使用可改善预后。患者和方法我们对 53 例中位随访时间为 11.0 个月的 R/R-AML 患者进行了回顾性单中心研究,比较了标准挽救化疗(FLAG-Ida 或 HAM,n = 35 例患者)与 Venetoclax(VEN)和 FLAG-Ida 联合治疗(FLAVIDA,n = 18 例患者)的安全性和有效性。结果在主要终点方面,根据单变量对数秩检验和多变量考克斯回归分析(HR 0.22 [95% CI 0.05, 0.97]),与接受标准化疗的患者相比,FLAVIDA组患者的无事件生存期(EFS)有显著的统计学提高。在出现发热性中性粒细胞减少症(CTCAE III°和 IV°)或血液学恢复延迟方面,两组患者之间没有差异。此外,FLAVIDA 组患者的总反应率(78% 对 51%)也有明显提高的趋势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Venetoclax Combined With FLAG-IDA in Refractory or Relapsed Acute Myeloid Leukemia

Venetoclax Combined With FLAG-IDA in Refractory or Relapsed Acute Myeloid Leukemia

Introduction

The prognosis of patients with refractory or relapsed AML (R/R-AML) is very limited. To (re)achieve complete remission, there has recently been increasing evidence that the combination of venetoclax (VEN) with chemotherapy is associated with improved outcomes.

Patients and Methods

Our retrospective, single-center study of 53 R/R-AML patients with a median follow-up time of 11.0 months compared standard salvage chemotherapy (FLAG-Ida or HAM in n = 35 patients) with a combination of venetoclax (VEN) and FLAG-Ida (FLAVIDA in n = 18 patients) concerning safety and efficacy.

Results

Regarding the primary endpoints, there was a statistically significant increased event free survival (EFS) in the FLAVIDA group compared to patients with standard chemotherapy based on the univariate log-rank-test and in the multivariate Cox regression analysis (HR 0.22 [95% CI 0.05, 0.97]). There were no differences between the two groups in terms of patients developing febrile neutropenia CTCAE III° and IV° or a delay in hematological recovery. In addition, a clear trend towards an improved overall response rate (78% vs. 51%) was demonstrated in the FLAVIDA group.

Conclusions

The FLAVIDA regimen represents a promising treatment alternative for R/R AML patients with a high response rate and significantly improved EFS compared to standard chemotherapy.

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来源期刊
CiteScore
5.50
自引率
0.00%
发文量
168
审稿时长
4-8 weeks
期刊介绍: European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
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