Samal Priyanka, Chakrabarti Prantar, Nath Uttam K
Institute of Hematology and Transfusion Medicine (IHTM), Kolkata, West Bengal, India.
Indian J Cancer. 2019 Jul-Sep;56(3):211-215. doi: 10.4103/ijc.IJC_303_18.
To compare the efficacy and safety of imatinib and cytarabine (ara-c) combination versus imatinib monotherapy in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML-CP).
This prospective, randomized study included adult patients (age >18 years) with newly diagnosed CML-CP. Patients received either a single oral dose of imatinib 400 mg/day in combination with a subcutaneous injection of ara-c 20 mg/m/day (imatinib + ara-c) or a single oral dose of imatinib 400 mg/day. Primary endpoints were hematological and molecular responses at 3 months and cytogenetic responses at 6 and 12 months. Secondary endpoints included grade 3/4 hematological and nonhematological adverse events (AEs).
Of 30 patients included, 14 were randomized to imatinib + ara-c and 16 to imatinib alone. Complete hematologic response (CHR) at 3 months was higher with imatinib + ara-c vs. imatinib alone (100% vs. 87.5%, P = 0.48). The median time to achieve CHR was significantly (P < 0.001) lower with imatinib + ara-c (32.07 vs. 23.43 days). Molecular response at 3 months was significantly higher (P = 0.04) with imatinib + ara-c vs. imatinib alone (100% vs. 68.75%). Complete cytogenetic response was also higher with imatinib + ara-c vs. imatinib alone (42.85% vs. 25% at 6 months and 71.4% vs. 62.5% at 12 months). Neutropenia followed by thrombocytopenia and anemia were the most common AEs. Grade 3/4 hematological and nausea events were significantly (P < 0.05) higher with imatinib + ara-c. Other nonhematological events were not significantly different between the treatments. The median follow-up duration was 20 months (range: 15-23 months).
Imatinib with low-dose ara-c can be considered as a potential first-line treatment option for CML-CP.
比较伊马替尼与阿糖胞苷（ara-c）联合用药与伊马替尼单药治疗新诊断的慢性期慢性髓性白血病（CML-CP）患者的疗效和安全性。
这项前瞻性随机研究纳入了新诊断为CML-CP的成年患者（年龄>18岁）。患者接受每日口服一次400毫克伊马替尼联合皮下注射每日20毫克/平方米阿糖胞苷（伊马替尼+阿糖胞苷）或每日口服一次400毫克伊马替尼。主要终点为3个月时的血液学和分子反应以及6个月和12个月时的细胞遗传学反应。次要终点包括3/4级血液学和非血液学不良事件（AE）。
纳入的30例患者中，14例随机分配至伊马替尼+阿糖胞苷组，16例分配至伊马替尼单药组。伊马替尼+阿糖胞苷组3个月时的完全血液学缓解（CHR）高于伊马替尼单药组（100%对87.5%，P = 0.48）。伊马替尼+阿糖胞苷组达到CHR的中位时间显著更短（P < 0.001）（32.07天对23.43天）。伊马替尼+阿糖胞苷组在3个月时的分子反应显著高于伊马替尼单药组（100%对68.75%，P = 0.04）。伊马替尼+阿糖胞苷组的完全细胞遗传学缓解也高于伊马替尼单药组（6个月时为42.85%对25%，12个月时为71.4%对62.5%）。中性粒细胞减少继以血小板减少和贫血是最常见的AE。伊马替尼+阿糖胞苷组的3/4级血液学和恶心事件显著更多（P < 0.05）。其他非血液学事件在治疗组之间无显著差异。中位随访时间为20个月（范围：15 - 23个月）。
低剂量阿糖胞苷联合伊马替尼可被视为CML-CP的一种潜在一线治疗选择。
