急性髓系白血病维持治疗的可行性和安全性

Utz Krug , Wolfgang E. Berdel , M. Cristina Sauerland , Achim Heinecke , Bernhard Woermann , Wolfgang Hiddemann , Thomas Buchner
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引用次数: 0

摘要

在这项研究中,我们提供了关于延长每月骨髓抑制维持治疗作为急性髓系白血病诱导和诱导型巩固后缓解后治疗的可行性和安全性的数据。57%的CR患者可以开始维持治疗,14%的患者可以完成维持治疗。我们之前的研究表明,延长每月的骨髓抑制化疗被证明优于高剂量阿糖胞苷巩固治疗(J clinical Oncol 2003;21:44 . 96)诱导治疗和诱导型巩固治疗后。在本研究中,AMLCG 1999试验评估了该方法的可行性和安全性。患者和方法827例2005年5月前的CR患者随机接受维持治疗(<结果827例患者中,326例(39%)患者因同种异体(63例;7.6%)或自体(6%;0.7%)干细胞移植;早期复发(126;15.3%);撤回同意(19;2.3%);复发以外的医疗原因(60;7.3%);其他未分类的原因(9;1.1%);或死亡缓解期(43;5.2%)。在30例(3.6%)患者中,由于缺乏随访或文献记录不完整,维持治疗的应用无法随访。对于剩余的471例(57.0%)有记录的开始维持治疗的患者,维持疗程的中位数为6个(第一到第三四分位数:2-16),从达到CR的中位数持续时间为10个月(第一到第三四分位数:5-24)。所有患者都需要减少剂量。在471例开始维持治疗的患者中,有348例(73.9%)患者由于首次CR的同种异体SCT而提前终止治疗(7例;1.5%);复发(205;43.5%);撤回同意(21;4.5%);复发以外的医疗原因(89;18.9%);其他未分类的原因(17;3.6%),缺少跟踪或文件不完整(55;11.7%);CR死亡率(8);1.7%)。69例(14.4%)患者完成了3年的维持治疗。结论:延长每月骨髓抑制维持治疗作为急性髓性白血病缓解后治疗的一部分是可行和安全的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Feasibility and Safety of Maintenance Therapy in the Treatment of Acute Myeloid Leukemia

In this study, we present data about the feasibility and safety of a prolonged monthly myelosuppressive maintenance therapy as a postremission therapy for acute myeloid leukemia after induction and induction-type consolidation. Maintenance therapy could be started in 57% of CR patients assigned to maintenance and completed in 14%.

Full Abstract

Introduction

We have previously shown that a prolonged monthly myelosuppressive chemotherapy proved superior to high-dose cytarabine consolidation therapy (J Clin Oncol 2003; 21:4496) after induction therapy and induction-type consolidation therapy. In this study, feasibility and safety of this approach was evaluated in the AMLCG 1999 trial.

Patients and Methods

827 patients with a CR before May 2005 were either randomized up front to receive maintenance therapy (< 60 years of age) or assigned to maintenance therapy (≥ 60 years of age) for 3 years after the achievement of a CR.

Results

Out of the 827 patients, 326 patients (39%) did not receive maintenance therapy due to allogeneic (63; 7.6%) or autologous (6; 0.7%) stem cell transplantation (SCT); early relapse (126; 15.3%); withdrawal of consent (19; 2.3%); medical reasons other than relapse (60; 7.3%); other reasons not classified (9; 1.1%); or death in remission (43; 5.2%). In 30 patients (3.6%), the application of maintenance therapy cannot be followed due to loss of follow-up or incomplete documentation. For the remaining 471 patients (57.0%) with a documented start of the maintenance therapy, the median number of maintenance courses applied was 6 (first to third quartile: 2–16) over a median duration from achievement of CR of 10 months (first to third quartile: 5–24). A dose reduction was necessary in all patients. Out of the 471 patients who started maintenance, therapy was terminated early in 348 patients (73.9%) due to an allogeneic SCT in first CR (7 patients; 1.5%); relapse (205; 43.5%); withdrawal of consent (21; 4.5%); medical reasons other than relapse (89; 18.9%); other reasons not classified (17; 3.6%), loss of follow-up or incomplete documentation (55; 11.7%); and death in CR (8; 1.7%). 69 patients (14.4%) completed maintenance for 3 years.

Conclusion

These results show that a prolonged monthly myelosuppressive maintenance therapy as part of a postremission therapy in AML is feasible and safe.

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