AML:伊达比星VS 高剂量柔红霉素,哪个更好?
创作:JM 审核:萝卜医生 2017年07月09日
  • 目的:比较伊达比星VS高剂量柔红霉素在新诊断急性髓系白血病(AML)的年轻患者中的效果;
  • 方法:招募299名患者,随机分配149名使用阿糖胞苷+伊达比星[AI],150名阿糖胞苷+高剂量柔红霉素[AD];
  • 结果:中位随访34.9月,完全缓解率、总生存率(OS)、无病生存率(EFS)、复发率无显著差异,不良反应相似;
  • 伴FLT3内部串联重复(FLT3-ITD)突变的患者中,OS和EFS差异显著,AD方案更好。
  • 结论:FLT3-ITD突变患者,高剂量柔红霉素效果更好。
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Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in Induction Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia

前瞻性随机分组比较伊达比星和高剂量柔红霉素用于新诊断的急性髓系白血病的诱导化疗

10.1200/JCO.2017.72.8618

2017-06-20, Report

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Purpose We compared two induction regimens, idarubicin (12 mg/m(2)/d for 3 days) versus high-dose daunorubicin (90 mg/m(2)/d for 3 days), in young adults with newly diagnosed acute myeloid leukemia (AML). Patients and Methods A total of 299 patients (149 randomly assigned to cytarabine plus idarubicin [AI] and 150 assigned to cytarabine plus high-dose daunorubicin [AD]) were analyzed. All patients received cytarabine (200 mg/m(2)/d for 7 days). Results Complete remission (CR) was induced in 232 patients (77.6%), with no difference in CR rates between the AI and AD arms (80.5% v 74.7%, respectively; P = .224). At a median follow-up time of 34.9 months, survival and relapse rates did not differ between the AI and AD arms (4-year overall survival, 51.1% v 54.7%, respectively; P = .756; cumulative incidence of relapse, 35.2% v 25.1%, respectively; P = .194; event-free survival, 45.5% v 50.8%, respectively; P = .772). Toxicity profiles were also similar in the two arms. Interestingly, overall and event-free survival times of patients with FLT3 internal tandem duplication (ITD) mutation were significantly different (AI v AD: median overall survival, 15.5 months v not reached, respectively; P = .030; event-free survival, 11.9 months v not reached, respectively; P = .028). Conclusion This phase III trial comparing idarubicin with high-dose daunorubicin did not find significant differences in CR rates, relapse, and survival. Significant interaction between the treatment arm and the FLT3-ITD mutation was found, and high-dose daunorubicin was more effective than idarubicin in patients with FLT3-ITD mutation.

First Authors:
Je-Hwan Lee

Correspondence Authors:
Je-Hwan Lee

All Authors:
Je-Hwan Lee,Hawk Kim,Young-Don Joo,Won-Sik Lee,Sung Hwa Bae,Dae Young Zang,Jihyun Kwon,Min Kyoung Kim,Junglim Lee,Gyeong Won Lee,Jung-Hee Lee,Yunsuk Choi,Dae-Young Kim,Eun-Hye Hur,Sung-Nam Lim,Sang-Min Lee,Hun Mo Ryoo,Hyo Jung Kim,Myung Soo Hyun,Kyoo-Hyung Lee,

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