急性髓系白血病诱导化疗患者预防性非辐照粒细胞输注的II期研究

F. Aung, C. Dinardo, Fern, O. Martínez, S. Pierce, N. Daver, T. Kadia, E. Jabbour, H. Kantarjian, B. Lichtiger, E. Freireich
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摘要

背景:急性髓性白血病(AML)患者存在严重的中性粒细胞减少;感染仍然是发病和死亡的主要原因。输注功能性非辐照的异基因粒细胞可以治疗或预防急性髓性白血病患者的感染,也可能具有抗白血病的益处。研究设计:无感染,诊断为AML或高危骨髓增生异常综合征,接受诱导或首次挽救治疗的患者符合条件。同种异体粒细胞输注(GTs)用于中性粒细胞减少(1例中性粒细胞减少发烧),平均每位患者有一次感染发作。其他不良反应包括荨麻疹/瘙痒(n=1)、皮疹(n=1)和低血压(n=1)。对白血病定向治疗的反应包括50%的完全缓解,70%的总缓解率和8%的8周死亡率。中位总生存期为15个月,1年生存率为51%。结论:对中性粒细胞减少的MDS/AML患者给予非辐照的功能性异体gt治疗是安全可行的。没有输血相关移植物抗宿主病(TA-GVHD)的报道,也没有描述毒性增加,包括在10%接受异体干细胞移植的患者中。在这一主要为老年AML的不同群体中,患者预后良好是值得注意的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Phase II Study of Prophylactic Non-Irradiated Granulocyte Transfusions in AML Patients Receiving Induction Chemotherapy
Background: Patients with Acute Myeloid Leukemia (AML) experience profound neutropenia; infections remain the leading cause of morbidity and mortality. Transfusion of functional non-irradiated allogeneic granulocytes may treat or prevent infections in AML patients, and may also have anti-leukemic benefits. Study Design: Patients free of infection, with a diagnosis of AML or high-risk myelodysplastic syndrome undergoing induction or first-salvage therapy were eligible. Allogeneic Granulocyte Transfusions (GTs) were administered to neutropenic (<0.5 × 109/L) patients every 3-4 days until sustained ANC recovery, initiation of new therapy, or completion of 6 weeks on study. Results: 45 patients enrolled with a median age of 67 years (range 23-83); 27 (60%) were male. Five patients (11%) never received a GT, due to donor screening failure and/or donor unavailability. 119 donors donated 156 granulocyte concentrates to the remaining 40 patients. The median number of GTs transfused per patient was 3 (range 1-9). All patients experienced >1 neutropenic fever, with an average of one infectious episode per patient. Other adverse reactions were urticaria/pruritis (n=1), rash (n=1), and hypotension (n=1). Response to leukemiadirected therapy included complete remission in 50%, overall response rate of 70%, and 8-week mortality of 8%. Median overall survival was 15 months, with 51% 1-year survival. Conclusion: Administration of non-irradiated functional allogeneic GTs to neutropenic MDS/AML patients is safe and feasible. No transfusion-associated graft-versus-host-disease (TA-GVHD) was reported and no increased toxicity was described, including among the 10% receiving subsequent allogeneic stem cell transplant. The favorable patient outcomes within this diverse group of primarily elderly AML are notable.
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