Luo Sheng, Cai Fangfang, Jiang Lei, Zhang Shenghui, Shen Zhijian, Sun Lan, Gao Shenmeng
Department of Hematology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang 325000, P.R. China.
Exp Ther Med. 2013 Mar;5(3):982-986. doi: 10.3892/etm.2013.917. Epub 2013 Jan 22.
Patients with relapsed acute myeloid leukemia (AML) have unfavorable prognosis and require innovative therapeutic approaches. In this study we used fludarabine combined with a middle dose of cytosine arabinoside (Ara-C), mitoxantrone and granulocyte-colony stimulating factor (G-CSF) as a salvage therapy for patients with relapsed AML in China. Forty-five patients with relapsed AML were treated with the Mito-FLAG regimen consisting of mitoxantrone (7 mg/m(2), day 1, 3 and 5), fludarabine (30 mg/m(2), days 1-5), Ara-C (1 g/m(2), over 3 h every 12 h, days 1-5) and G-CSF [5 μg/kg/day subcutaneously from day 0 until the white blood count (WBC) was >20×10(9)/l]. Patients with a partial response (PR) received another course of the same regimen. Patients with a suitable donor and aged <50 years received allogeneic stem cell transplantation (allo-SCT). Twenty-three patients (51%) and 3 patients (7%) achieved complete remission (CR) and PR, respectively, following one or two courses of Mito-FLAG, and the overall response (OR) rate was 58%. Nine patients (20%) received allo-SCT and 4 patients (9%) succumbed early. Hematological toxicity and infections were the most prominent toxicities of this regimen. Other toxicities included nausea, vomiting, bleeding, hyperbilirubinemia, renal toxicity and arrhythmia. The probability of overall survival (OS) at 4 years was 19% (95% CI, 11-26%) and the probability of 4-year disease-free survival (DFS) was 29% for all 23 patients in CR (95% CI, 18-41%). Our data suggest that Mito-FLAG is a highly effective and well-tolerated salvage regimen for relapsed AML.
复发急性髓系白血病（AML）患者预后不佳，需要创新的治疗方法。在本研究中，我们在中国将氟达拉滨与中剂量阿糖胞苷（Ara-C）、米托蒽醌和粒细胞集落刺激因子（G-CSF）联合使用，作为复发AML患者的挽救治疗方案。45例复发AML患者接受了由米托蒽醌（7 mg/m²，第1、3和5天）、氟达拉滨（30 mg/m²，第1 - 5天）、Ara-C（1 g/m²，每12小时静脉滴注3小时，第1 - 5天）和G-CSF[从第0天开始皮下注射5 μg/kg/天，直至白细胞计数（WBC）>20×10⁹/L]组成的Mito-FLAG方案治疗。部分缓解（PR）的患者接受另一疗程相同方案治疗。有合适供体且年龄<50岁的患者接受异基因干细胞移植（allo-SCT）。23例患者（51%）和3例患者（7%）在接受一或两个疗程的Mito-FLAG治疗后分别达到完全缓解（CR）和PR，总缓解（OR）率为58%。9例患者（20%）接受了allo-SCT，4例患者（9%）早期死亡。血液学毒性和感染是该方案最突出的毒性反应。其他毒性反应包括恶心、呕吐、出血、高胆红素血症以及肾毒性和心律失常。所有23例CR患者4年总生存（OS）概率为19%（95%CI，11 - 26%），4年无病生存（DFS）概率为29%（95%CI，18 - 41%）。我们的数据表明，Mito-FLAG是一种对复发AML高度有效且耐受性良好的挽救方案。
