Granulocyte–Macrophage Colony-Stimulating Factor after Initial Chemotherapy for Elderly Patients with Primary Acute Myelogenous Leukemia

Background Elderly patients with primary acute myelogenous leukemia (AML) are less likely to enter remission than younger adults, in part because of a higher mortality rate related to severe myelosuppression. Granulocyte–macrophage colony-stimulating factor (GM-CSF) has been shown to shorten the duration of neutropenia and decrease infectious complications when administered after chemotherapy to patients with lymphomas and solid tumors. Methods We randomly assigned 388 patients 60 years of age or older who had newly diagnosed primary AML to receive placebo or GM-CSF (5 μg per kilogram of body weight per day intravenously) in a double-blind manner, beginning the day after the completion of three days of daunorubicin and seven days of cytarabine. If leukemic cells persisted in the marrow three weeks after the initiation of chemotherapy, further daunorubicin (two days) and cytarabine (five days) were administered. GM-CSF or placebo was given daily until the neutrophil count was at least 1000 per cubic millim...