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首页> 外文期刊>Journal of geriatric oncology >Phase I study of dose dense induction and consolidation with gemtuzumab ozogamicin and high dose cytarabine in older adults with AML
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Phase I study of dose dense induction and consolidation with gemtuzumab ozogamicin and high dose cytarabine in older adults with AML

机译：一期研究针对老年AML患者用吉妥单抗ozogamicin和高剂量阿糖胞苷进行剂量密集诱导和巩固

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Objective: Older adults with acute myeloid leukemia (AML) tend to have worse complete remission (CR) rates and overall survival compared to their younger counterparts. At least one reason for this is increased expression of the multidrug resistance gene (MDR1). Dose dense, high intensity chemotherapy may overcome the MDR1 effect, possibly when combined with anti-CD33 monoclonal antibody gemtuzumab ozogamicin (GO,Mylotarg?), which has been studied in older adults with relapsed AML. This phase I study was aimed at establishing safety by defining a maximum tolerated dose (MTD) by treating older AML patients with two cycles of dose-dense therapy with high dose cytarabine (HiDAC) combined with targeted therapy using GO. Materials and methods: Nine patients ≥60years with newly diagnosed, untreated CD33+ AML with adequate renal and hepatic function, and ECOG PS 0-2 were eligible. HiDAC was administered at two dose levels: 3000mg/m 2 every 12h for 6 doses (cohort 1), or 9 doses (cohort 2). GO was administered at 6mg/m 2 on days 1 and 8. Results: The MTD was HiDAC 3000mg/m 2 for six doses along with GO 6mg/m 2. All patients had grades 3-4 pancytopenia, and two patients developed reversible grade 2 neurotoxicity. There were no cases of veno-occlusive disease. Seven of nine patients had a complete response (CR or CRp). Conclusions: There was no difference in relapse-free survival in our patients when compared to historical data. However, despite high toxicity, two of nine patients treated in this dose-dense fashion remained in CR for 60 months.
机译：目的：与年轻人相比，患有急性髓细胞性白血病（AML）的成年人的完全缓解（CR）率和总生存率往往较差。造成这种情况的至少一个原因是多药耐药基因（MDR1）的表达增加。剂量密集，高强度的化疗可能会克服MDR1的作用，可能与抗CD33单克隆抗体吉妥单抗ozogamicin（GO，Mylotarg？）联合使用时，已对老年复发性AML患者进行了研究。这项第一阶段的研究旨在通过使用高剂量阿糖胞苷（HiDAC）结合高剂量阿糖胞苷（HiDAC）的两个剂量密集疗法与GO靶向疗法治疗老年AML患者来确定最大耐受剂量（MTD），从而建立安全性。材料和方法：≥60岁的9例≥60岁的新诊断，未经治疗的CD33 + AML具有良好的肾和肝功能，并符合ECOG PS 0-2标准。 HiDAC的给药剂量为两种：每12小时3000mg / m 2，共6剂（组1）或9剂（组2）。在第1天和第8天以6mg / m 2的剂量施用GO。结果：MTD为HiDAC 3000mg / m 2，共6剂，GO 6mg / m2。所有患者的3-4级全血细胞减少症，两名患者发展为可逆级2神经毒性。没有静脉阻塞性疾病的病例。 9名患者中有7名完全缓解（CR或CRp）。结论：与历史数据相比，我们患者的无复发生存率没有差异。然而，尽管毒性很高，但以这种剂量密集方式治疗的9例患者中有2例仍在CR中生存60个月以上。

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