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Blood, 15 January 2004, Vol. 103, No. 2, pp. 479-485.
Prepublished online as a Blood First Edition Paper on September 25, 2003; DOI 10.1182/blood-2003-05-1686.
Previous Article | Table of Contents | Next Article 
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
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 Paietta,
Adel Z. Makary,
Jane L. Liesveld,
Camille N. Abboud,
Gordon Dewald,
F. Ann Hayes,
Martin S. Tallman, and
Peter H. Wiernik
From the Rambam Medical Center and Technion, Haifa, Israel; Dana Farber Cancer Institute, Boston, MA; Guthrie Medical Center, Sayre, PA; University of Rochester Cancer Center, Rochester, NY; Our Lady of Mercy Cancer Center, New York Medical College, Bronx, NY; Geisinger Medical Center, Danville, PA; Mayo Clinic, Rochester, MN; Immunex Corp, Seattle, WA; and Northwestern University Feinberg School of Medicine, Chicago, IL.
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.

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