CPX-351联合或不联合吉妥珠单抗奥唑米星作为新诊断的、预后中等风险、FLT3-ITD阴性的成年急性髓系白血病患者的诱导治疗：一项试点研究。
CPX-351 +/- gemtuzumab ozogamicin as induction therapy for adult patients with newly diagnosed, favourable-intermediate risk, FLT3-ITD negative, AML: A pilot study.
作者信息
Ganzel Chezi, Frisch Avraham, Wolach Ofir, Moshe Yakir, Krayem Baher, Dor Neta, Broide Etti, Benayoun Emmanuel, Rowe Jacob M, Ofran Yishai
机构信息
Hematology and Bone Marrow Transplantation Department, the Eisenberg R&D Authority, Shaare Zedek Medical Center, and Faculty of Medicine, Hebrew University, Jerusalem, Israel.
Department of Hematology and Bone Marrow Transplantation, Rambam Health Care Campus, Haifa, Israel.
出版信息
Br J Haematol. 2025 Feb;206(2):551-555. doi: 10.1111/bjh.19967. Epub 2024 Dec 25.
This pilot study evaluated CPX-351 in adults with newly diagnosed, favourable-intermediate risk, FLT3-ITD-negative AML. Twenty patients received CPX-351 for induction, with six also receiving gemtuzumab ozogamicin (GO). The complete response rate was 95%, with 42% achieving flow-based minimal residual disease (MRD) negativity post-induction. The 18-month leukaemia-free and overall survival estimates were 80% and 95% respectively. Adding GO appeared safe without prolonged cytopenias. Subclinical cardiotoxicity was observed in 25% of patients. The study demonstrated CPX-351's feasibility, with response and MRD-negativity rates comparable to standard '7 + 3' induction.
这项初步研究评估了CPX-351在新诊断的、预后中等风险、FLT3-ITD阴性的成年急性髓系白血病（AML）患者中的疗效。20例患者接受CPX-351进行诱导治疗，其中6例还接受了吉妥单抗奥唑米星（GO）治疗。完全缓解率为95%，42%的患者在诱导治疗后实现了基于流式细胞术的微小残留病（MRD）阴性。18个月无白血病生存率和总生存率估计分别为80%和95%。添加GO似乎是安全的，且没有长期血细胞减少。25%的患者观察到亚临床心脏毒性。该研究证明了CPX-351的可行性，其缓解率和MRD阴性率与标准的“7+3”诱导方案相当。
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