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东部肿瘤协作组进行的一项针对老年急性髓系白血病患者的三种诱导方案及粒细胞巨噬细胞集落刺激因子(GM-CSF)启动治疗的3期研究。

A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: a trial by the Eastern Cooperative Oncology Group.

作者信息

Rowe Jacob M, Neuberg Donna, Friedenberg William, Bennett John M, Paietta Elisabeth, Makary Adel Z, Liesveld Jane L, Abboud Camille N, Dewald Gordon, Hayes F Ann, Tallman Martin S, Wiernik Peter H

机构信息

Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center and Technion, Haifa 31096 Israel.

出版信息

Blood. 2004 Jan 15;103(2):479-85. doi: 10.1182/blood-2003-05-1686. Epub 2003 Sep 25.

DOI:10.1182/blood-2003-05-1686
PMID:14512295
Abstract

The optimal induction for older adults with acute myeloid leukemia (AML) is unknown. Several anthracyclines have been proposed, but the data remain equivocal. Additionally, few prospective trials of priming with hematopoietic growth factors to cycle leukemia cells prior to induction chemotherapy have been conducted. Three hundred and sixty-two older adults with previously untreated AML were randomized to either daunorubicin, idarubicin or mitoxantrone with a standard dose of cytarabine as induction therapy. In addition, 245 patients were also randomized to receive granulocyte-macrophage colony-stimulating factor (GM-CSF) or placebo beginning 2 days prior to induction chemotherapy and continuing until marrow aplasia. No difference was observed in the disease-free overall survival or in toxicity among patients receiving any of the 3 induction regimens or among those receiving growth factor or placebo for priming. However, the complete remission rate for the first 113 analyzable patients, who did not participate in the priming study and started induction therapy 3 to 5 days earlier than those who did, was significantly higher (50% versus 38%; P =.03). None of the anthracyclines is associated with improved outcome in older adults. Priming with hematopoietic growth factor did not improve response when compared with placebo. Furthermore, delaying induction therapy in older adults may lead to a lower complete remission rate.

摘要

老年急性髓系白血病(AML)患者的最佳诱导治疗方案尚不清楚。已有多种蒽环类药物被提出,但数据仍不明确。此外,很少有关于在诱导化疗前用造血生长因子使白血病细胞同步化的前瞻性试验。362例既往未治疗的老年AML患者被随机分为接受柔红霉素、伊达比星或米托蒽醌联合标准剂量阿糖胞苷作为诱导治疗。另外,245例患者也被随机分组,从诱导化疗前2天开始接受粒细胞-巨噬细胞集落刺激因子(GM-CSF)或安慰剂治疗,持续至骨髓抑制期。在接受3种诱导方案中的任何一种的患者之间,以及在接受生长因子或安慰剂预处理的患者之间,无病总生存期或毒性均未观察到差异。然而,首批113例可分析患者(未参与预处理研究且比参与研究的患者提前3至5天开始诱导治疗)的完全缓解率显著更高(50%对38%;P = 0.03)。没有一种蒽环类药物能改善老年患者的预后。与安慰剂相比,用造血生长因子预处理并未改善反应。此外,延迟老年患者的诱导治疗可能导致较低的完全缓解率。

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