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

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

Research output: Contribution to journalArticle

217 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)479-485
Number of pages7
JournalBlood
Volume103
Issue number2
DOIs
StatePublished - Jan 15 2004
Externally publishedYes

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Oncology
Granulocyte-Macrophage Colony-Stimulating Factor
Acute Myeloid Leukemia
Intercellular Signaling Peptides and Proteins
Induction Chemotherapy
Chemotherapy
Anthracyclines
Placebos
Idarubicin
Mitoxantrone
Daunorubicin
Cytarabine
Disease-Free Survival
Toxicity
Cell Cycle
Leukemia
Therapeutics
Bone Marrow

ASJC Scopus subject areas

  • Hematology

Cite this

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

In: Blood, Vol. 103, No. 2, 15.01.2004, p. 479-485.

Research output: Contribution to journalArticle

Rowe, JM, Neuberg, D, Friedenberg, W, Bennett, JM, Paietta, EM, Makary, AZ, Liesveld, JL, Abboud, CN, Dewald, G, Hayes, FA, Tallman, MS & Wiernik, PH 2004, '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', Blood, vol. 103, no. 2, pp. 479-485. https://doi.org/10.1182/blood-2003-05-1686
Rowe, Jacob M. ; Neuberg, Donna ; Friedenberg, William ; Bennett, John M. ; Paietta, Elisabeth M. ; Makary, Adel Z. ; Liesveld, Jane L. ; Abboud, Camille N. ; Dewald, Gordon ; Hayes, F. Ann ; Tallman, Martin S. ; Wiernik, Peter H. / 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. In: Blood. 2004 ; Vol. 103, No. 2. pp. 479-485.
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