{"title":"The Impact of Gilteritinib on Overall Survival of Adult Patients with FLT3 Positive Acute Myeloid Leukemia: A Systematic Review.","authors":"Shipra Vinod Gupta, Nadina Jose, Barbara Tafuto","doi":"10.21801/ppcrj.2024.102.7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Gilteritinib, an effective and selective inhibitor of the FLT3 gene, was developed to address the challenges posed by relapsed or refractory acute myeloid leukemia (AML) patients who often encounter limited treatment options and poor prognoses with salvage chemotherapy.</p><p><strong>Aim: </strong>This systematic review aims to explore the progression of interventional research and consolidate existing evidence on the clinical effectiveness of gilteritinib as a monotherapy or combination therapy in improving overall survival among adults experiencing a recurrence or resistance to treatment for FLT3-positive AML patients.</p><p><strong>Methods: </strong>A comprehensive search strategy, utilizing Medical Subject Headings (MeSH) and non-MeSH terms was conducted across Pubmed, EMBASE, Cochrane, and Web of Science databases. We primarily focused on the clinical trial and retrospective studies on gilteritinib as an intervention for relapsed/refractory AML patients.</p><p><strong>Results: </strong>According to our predefined criteria for inclusion and exclusion, we identified 3 published clinical trials and 5 retrospective studies focused on the overall response of gilteritinib on refractory or relapsed AML adult patients published between January 1, 2018, and March 25, 2024. Clinical trial studies demonstrated superior survival outcomes than salvage chemotherapy in the FLT3-positive AML population particularly showing higher efficacy in combination therapy with Azacitidine. Retrospective studies from clinical trials revealed improved clinical outcomes in AML sub-populations.</p><p><strong>Conclusion: </strong>Gilteritinib exhibited promising outcomes by targeting FLT3 receptors, offering a new treatment approach, and revealing improved overall survival compared to salvage chemotherapy in the difficult-to-treat patient population.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"10 2","pages":"47-59"},"PeriodicalIF":0.0000,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618817/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Principles and practice of clinical research (2015)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21801/ppcrj.2024.102.7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/22 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Gilteritinib, an effective and selective inhibitor of the FLT3 gene, was developed to address the challenges posed by relapsed or refractory acute myeloid leukemia (AML) patients who often encounter limited treatment options and poor prognoses with salvage chemotherapy.
Aim: This systematic review aims to explore the progression of interventional research and consolidate existing evidence on the clinical effectiveness of gilteritinib as a monotherapy or combination therapy in improving overall survival among adults experiencing a recurrence or resistance to treatment for FLT3-positive AML patients.
Methods: A comprehensive search strategy, utilizing Medical Subject Headings (MeSH) and non-MeSH terms was conducted across Pubmed, EMBASE, Cochrane, and Web of Science databases. We primarily focused on the clinical trial and retrospective studies on gilteritinib as an intervention for relapsed/refractory AML patients.
Results: According to our predefined criteria for inclusion and exclusion, we identified 3 published clinical trials and 5 retrospective studies focused on the overall response of gilteritinib on refractory or relapsed AML adult patients published between January 1, 2018, and March 25, 2024. Clinical trial studies demonstrated superior survival outcomes than salvage chemotherapy in the FLT3-positive AML population particularly showing higher efficacy in combination therapy with Azacitidine. Retrospective studies from clinical trials revealed improved clinical outcomes in AML sub-populations.
Conclusion: Gilteritinib exhibited promising outcomes by targeting FLT3 receptors, offering a new treatment approach, and revealing improved overall survival compared to salvage chemotherapy in the difficult-to-treat patient population.
背景:Gilteritinib是一种有效和选择性的FLT3基因抑制剂,用于解决复发或难治性急性髓性白血病(AML)患者所面临的挑战,这些患者经常遇到有限的治疗选择和预后不良的补救性化疗。目的:本系统综述旨在探讨介入研究的进展,并巩固现有证据,证明gilteritinib作为单药或联合治疗在改善flt3阳性AML复发或耐药的成人患者的总生存率方面的临床有效性。方法:在Pubmed、EMBASE、Cochrane和Web of Science数据库中使用医学主题词(MeSH)和非MeSH术语进行综合搜索策略。我们主要关注gilteritinib作为复发/难治性AML患者干预的临床试验和回顾性研究。结果:根据我们预定义的纳入和排除标准,我们确定了2018年1月1日至2024年3月25日期间发表的3项已发表的临床试验和5项回顾性研究,重点关注吉特替尼对难治性或复发性AML成人患者的总体反应。临床试验研究表明,在flt3阳性AML人群中,生存结果优于补救性化疗,特别是与阿扎胞苷联合治疗的疗效更高。临床试验的回顾性研究显示急性髓性白血病亚群的临床结果有所改善。结论:Gilteritinib通过靶向FLT3受体显示出有希望的结果,提供了一种新的治疗方法,与挽救性化疗相比,在难以治疗的患者群体中显示出更高的总生存率。