Pilot remission induction therapy with idarubicin, plus an intensified dose of Ara-C and priming with granulocyte colony-stimulating factor for acute myeloid leukemia
Pilot remission induction therapy with idarubicin, plus an intensified dose of Ara-C and priming with granulocyte colony-stimulating factor for acute myeloid leukemia
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DOI：
10.1159/000097386
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发表时间：
2007-01-01
影响因子：
2.4
通讯作者：
Kim, Hyeoung-Joon
中科院分区：
文献类型：
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作者：
Baek, Jin Ho;Sohn, Sang Kyun;Kim, Hyeoung-Joon
背景资料：造血生长因子致敏白血病细胞可增强化疗药物对急性髓细胞白血病（AML）的细胞毒作用。强化缓解诱导（RI）治疗也可以改善AML的治疗结果。因此，目前的试验试图评估粒细胞集落刺激因子（G-CSF）的启动和阿糖胞苷的剂量强化在急性髓细胞白血病RI化疗中的疗效和毒性。研究方法：共有29名新诊断的AML患者接受了G-CSF-预激RI化疗，包括艾达鲁肽（12 mg/m2，第1-3天）、G-CSF（150 μ g/m2，第3-8天）和Ara-C（500 mg/m2，b.i.d.，第4-8天），并将其结果与接受标准方案治疗的历史组进行比较，该方案由艾达鲁肽（12 mg/m2，第1-3天）和阿糖胞苷（100 mg/m2，第1-7天）组成。结果：两组患者的性别、年龄、亚型及细胞遗传学危险性无差异。G-CSF预处理组的完全缓解率和治疗相关死亡率分别为72%和17%（p = 0.89），历史组分别为71%和10%（p = 0.32）。两组之间的中性粒细胞恢复时间（25 vs 24天，p = 0.17）和血小板恢复时间（24 vs 23天，p = 0.23）无显著差异。同样，发热持续时间也无显著差异（5 vs. 7天，p = 0. 58）。13例患者（45%）在G-CSF预充期间出现发热，5例患者（17%）出现皮疹。中位随访336天后，1年总生存率、无病生存率和无事件生存率分别为72 vs. 63%（p = 0.83）、74 vs. 56%（p = 0.059）和53 vs. 38%（p = 0.32）。结论：白血病细胞与生长因子的致敏和剂量强化似乎是临床上适用的手段，以提高RI化疗的疗效，只有在选定的AML患者，从而避免进一步的研究集中在特定的亚组AML患者。版权所有（c）2007 S. Karger AG，巴塞尔。
Background: The sensitization of leukemic cells with hematopoietic growth factors can enhance the cytotoxicity of chemotherapy in acute myeloid leukemia (AML). Intensified remission induction (RI) therapy can also improve the treatment results for AML. Therefore, the current trial attempted to evaluate the efficacy and toxicity of granulocyte colony-stimulating factor (G-CSF) priming and a dose intensification of Ara-C in RI chemotherapy for AML. Methods: A total of 29 patients with newly diagnosed AML received G-CSF-priming RI chemotherapy consisting of idarubicin (12 mg/m(2), days 1-3), G-CSF (150 mu g/m(2), days 3-8) and Ara-C (500 mg/m(2), b.i.d., days 4-8), and the outcomes were compared with those of a historical group treated with a standard regimen consisting of idarubicin (12 mg/m(2), days 1-3) and Ara-C (100 mg/m(2), days 1-7). Results: There was no difference in sex, age, subtype and cytogenetic risk between the two groups. The complete remission rate and treatment-related mortality were 72 and 17% for the G-CSF-primed group (p = 0.89) and 71 and 10% for the historical group (p = 0.32), respectively. The time to neutrophil recovery (25 vs. 24 days, p = 0.17) and platelet recovery (24 vs. 23 days, p = 0.23) did not differ significantly between the two groups. Similarly, the duration of fever was not significantly different (5 vs. 7 days, p = 0.58). Thirteen patients (45%) experienced fever and 5 patients (17%) manifested skin rashes during the G-CSF priming. After a median follow-up of 336 days, the 1-year overall survival, disease-free survival and event-free survival rates were 72 vs. 63% (p = 0.83), 74 vs. 56% (p = 0.059) and 53 vs. 38% (p = 0.32), respectively. Conclusion: The sensitization of leukemic cells with growth factors and dose intensification seem to be clinically applicable means to enhance the efficacy of RI chemotherapy only in selected patients with AML, thereby warranting further studies focusing on specific subgroups of AML patients. Copyright (c) 2007 S. Karger AG, Basel.