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。

Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in Induction Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia



2017-06-20, Report

Abstract & Authors:展开

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,