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
<P> The optimal induction for older adults with acute myeloid leukemia<SUP> </SUP>(AML) is unknown. Several anthracyclines have been proposed,<SUP> </SUP>but the data remain equivocal. Additionally, few prospective<SUP> </SUP>trials of priming with hematopoietic growth factors to cycle<SUP> </SUP>leukemia cells prior to induction chemotherapy have been conducted.<SUP> </SUP>Three hundred and sixty-two older adults with previously untreated<SUP> </SUP>AML were randomized to either daunorubicin, idarubicin or mitoxantrone<SUP> </SUP>with a standard dose of cytarabine as induction therapy. In<SUP> </SUP>addition, 245 patients were also randomized to receive granulocyte-macrophage<SUP> </SUP>colony-stimulating factor (GM-CSF) or placebo beginning 2 days<SUP> </SUP>prior to induction chemotherapy and continuing until marrow<SUP> </SUP>aplasia. No difference was observed in the disease-free overall<SUP> </SUP>survival or in toxicity among patients receiving any of the<SUP> </SUP>3 induction regimens or among those receiving growth factor<SUP> </SUP>or placebo for priming. However, the complete remission rate<SUP> </SUP>for the first 113 analyzable patients, who did not participate<SUP> </SUP>in the priming study and started induction therapy 3 to 5 days<SUP> </SUP>earlier than those who did, was significantly higher (50% versus<SUP> </SUP>38%; <I>P</I> = .03). None of the anthracyclines is associated with<SUP> </SUP>improved outcome in older adults. Priming with hematopoietic<SUP> </SUP>growth factor did not improve response when compared with placebo.<SUP> </SUP>Furthermore, delaying induction therapy in older adults may<SUP> </SUP>lead to a lower complete remission rate.</P>
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《血液学杂志》2004年1月第103卷第2期