甲磺酸伊马替尼作为新诊断的 C-kit 阳性急性髓系白血病患者维持治疗的 II 期临床试验。
A Phase II Trial of Imatinib Mesylate as Maintenance Therapy for Patients With Newly Diagnosed C-kit-positive Acute Myeloid Leukemia.
机构信息
Department of Hematology/ Oncology, Cleveland Clinic Taussig Cancer Institute Leukemia Program, Cleveland, OH.
Department of Hematology/ Oncology, Metro Health, Cleveland, OH.
出版信息
Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):113-118. doi: 10.1016/j.clml.2020.11.018. Epub 2020 Dec 3.
INTRODUCTION
Adults with acute myeloid leukemia (AML) have a high rate of remission; however, more than 50% relapse. C-kit is expressed in approximately 60% of patients with de novo AML and represents a potential therapeutic target.
MATERIALS AND METHODS
Patients with newly diagnosed AML received 12 months of imatinib mesylate as maintenance therapy after the completion of post-remission therapy. The primary objective was to determine whether this approach improved progression-free survival (defined as no relapse and no death) compared with historical controls.
RESULTS
The median progression-free survival of patients < 60 years of age was 52.1 months (historical control, 13 months) and for patients ≥ 60 years of age was 10.7 months (historical control, 8 months). The median level of AF1q expression was high (9.59), and 84% of patients had moderate or high levels of drug-resistance factors.
CONCLUSIONS
Imatinib maintenance therapy may improve the outcome of newly diagnosed patients with AML who are < 60 years of age.
简介
成人急性髓系白血病（AML）有很高的缓解率；然而，超过 50%的患者会复发。约 60%的初诊 AML 患者表达 C-kit，代表了一个潜在的治疗靶点。
材料与方法
新诊断为 AML 的患者在缓解后治疗完成后接受 12 个月的甲磺酸伊马替尼维持治疗。主要目的是确定与历史对照相比，这种方法是否能改善无进展生存（定义为无复发且无死亡）。
结果
< 60 岁患者的中位无进展生存期为 52.1 个月（历史对照为 13 个月），≥ 60 岁患者的中位无进展生存期为 10.7 个月（历史对照为 8 个月）。AF1q 表达水平中位数较高（9.59），84%的患者有中度或高度耐药因素。
结论
伊马替尼维持治疗可能改善< 60 岁新诊断 AML 患者的预后。
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