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首页> 外文期刊>Leukemia >Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome
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Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome

机译：新诊断为急性髓细胞性白血病或高危骨髓增生异常综合征患者中低剂量阿糖胞苷联合格拉斯地布或不联合格拉斯地布的随机比较

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Glasdegib is a Hedgehog pathway inhibitor. This phase II, randomized, open-label, multicenter study (ClinicalTrials.gov, NCT01546038) evaluated the efficacy of glasdegib plus low-dose cytarabine (LDAC) in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome unsuitable for intensive chemotherapy. Glasdegib 100mg (oral, QD) was administered continuously in 28-day cycles; LDAC 20mg (subcutaneous, BID) was administered for 10 per 28 days. Patients (stratified by cytogenetic risk) were randomized (2:1) to receive glasdegib/LDAC or LDAC. The primary endpoint was overall survival. Eighty-eight and 44 patients were randomized to glasdegib/LDAC and LDAC, respectively. Median (80% confidence interval [CI]) overall survival was 8.8 (6.99.9) months with glasdegib/LDAC and 4.9 (3.56.0) months with LDAC (hazard ratio, 0.51; 80% CI, 0.390.67, P=0.0004). Fifteen (17.0%) and 1 (2.3%) patients in the glasdegib/LDAC and LDAC arms, respectively, achieved complete remission (P<0.05). Nonhematologic grade 3/4 all-causality adverse events included pneumonia (16.7%) and fatigue (14.3%) with glasdegib/LDAC and pneumonia (14.6%) with LDAC. Clinical efficacy was evident across patients with diverse mutational profiles. Glasdegib plus LDAC has a favorable benefitrisk profile and may be a promising option for AML patients unsuitable for intensive chemotherapy.
机译：Glasdegib是一种Hedgehog途径抑制剂。这项II期随机，开放标签，多中心研究（ClinicalTrials.gov，NCT01546038）评估了格拉斯地比加小剂量阿糖胞苷（LDAC）在急性髓性白血病（AML）或高危骨髓增生异常综合症患者中的疗效化学疗法。在28天的周期中连续服用Glasdegib 100mg（口服，QD）。每28天服用LDAC 20mg（皮下注射，BID）10次。患者（按细胞遗传学风险分层）被随机分配（2：1）接受glasdegib / LDAC或LDAC。主要终点是总体生存率。分别将88例和44例患者随机分为glasdegib / LDAC和LDAC。 Glasdegib / LDAC的中位生存期（80％置信区间[CI]）为8.8（6.99.9）个月，LDAC的中位生存期为（4.81; 80％CI，0.390.67，P = 0.0004）。 glasdegib / LDAC和LDAC组分别有15例（17.0％）和1例（2.3％）实现了完全缓解（P <0.05）。非血液学3/4级全因不良事件包括glasdegib / LDAC引起的肺炎（16.7％）和疲劳（14.3％），LDAC引起的肺炎（14.6％）。在具有各种突变特征的患者中，临床疗效显而易见。 Glasdegib加上LDAC具有良好的获益风险，对于不适合强化化疗的AML患者可能是一个有前途的选择。

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