Acute Myeloid Leukemia (AML): Different Treatment Strategies Versus a Common Standard Arm-Combined Prospective Analysis by the German AML Intergroup
Acute Myeloid Leukemia (AML): Different Treatment Strategies Versus a Common Standard Arm-Combined Prospective Analysis by the German AML Intergroup
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DOI：
10.1200/jco.2012.42.2907
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发表时间：
2012-10-10
影响因子：
45.3
通讯作者：
Pfirrmann, Markus
中科院分区：
文献类型：
--
作者：
Buechner, Thomas;Schlenk, Richard F.;Pfirrmann, Markus
研究目的：为了确定急性髓系白血病（AML）患者的真正治疗进展，需要在统一患者选择的基础上比较治疗策略和结果。为了促进五项临床研究的可比性，我们引入了一个共同的标准臂，结合一般的前期随机化，并进行了前瞻性分析，调整了预后基线特征的差异。标准组包括统一的基于阿糖胞苷和蒽环类药物的标准剂量缓解诱导和高剂量巩固疗程。290例患者被随机分配到共同标准组，70%的患者达到完全缓解（62%完全恢复，8%不完全恢复; 95%CI，65%-76%）。总生存期的5年生存概率为44.3%（95% CI，37.7%至50.7%），无复发生存期为44.8%（95% CI，37.0%至52.2%），无事件生存期为31.5%（95% CI，25.7%至37.4%）。卡普兰指数的未调整生存概率-Meier方法和多个考克斯回归模型中对预后变量的调整均导致了三个生存终点的统计学显著差异，当每个研究的结果与标准组进行比较时，结论AML患者不同治疗策略的严格前瞻性比较在通过一项研究进行比较时并未显示出临床相关的结果差异。共同的标准治疗臂。结果提供了一个代表性的基础，进一步的治疗方法。J Clin Oncol 30：3604-3610. (C)2012年美国临床肿瘤学会
PurposeIdentifying true therapeutic progress in patients with acute myeloid leukemia (AML) requires a comparison of treatment strategies and results on the basis of uniform patient selection. To foster comparability across five clinical studies, we introduced a common standard arm combined with a general upfront randomization and performed prospective analyses with adjustment for differences in prognostic baseline characteristics.Patients and MethodsWhereas the studies' own regimens differed in chemotherapies, risk adaption, and guidelines for allogeneic stem-cell transplantation, the standard arm contained uniform cytarabine-and anthracycline-based standard-dose remission induction and high-dose consolidation courses.ResultsOf 2,995 evaluable patients aged 16 to 60 years, 290 patients were randomly assigned to the common standard arm. Seventy percent of the 290 achieved complete remissions (62% with complete recovery, 8% with incomplete recovery; 95% CI, 65% to 76%). Five-year survival probabilities were 44.3% (95% CI, 37.7% to 50.7%) for overall survival, 44.8% (95% CI, 37.0% to 52.2%) for relapse-free survival, and 31.5% (95% CI, 25.7% to 37.4%) for event-free survival. Neither the unadjusted survival probabilities of the Kaplan-Meier method nor their adjustment for prognostic variables in multiple Cox regression models led to statistically significant different results in the three survival end points when the outcomes of each study were compared with the standard arm.ConclusionA strictly prospective comparison of different treatment strategies in patients with AML did not show clinically relevant outcome differences when compared through a common standard treatment arm. The results provide a representative basis for further therapeutic approaches. J Clin Oncol 30: 3604-3610. (C) 2012 by American Society of Clinical Oncology