HUMAN URINARY MACROPHAGE-COLONY-STIMULATING FACTOR REDUCES THE INCIDENCE AND DURATION OF FEBRILE NEUTROPENIA AND SHORTENS THE PERIOD REQUIRED TO FINISH 3 COURSES OF INTENSIVE CONSOLIDATION THERAPY IN ACUTE MYELOID-LEUKEMIA - A DOUBLE-BLIND CONTROLLED-STUDY

Purpose: To determine whether macrophage colony-stimulating factor (M- CSF) reduces the incidence and duration of febrile neutropenia during three courses of intensive consolidation therapy and whether it shorte ns time to complete consolidation therapy. Patients and Methods: In 19 8 adult patients with acute myeloid leukemia (AML) in complete remissi on (CR), M-CSF (8 x 10(6) U/d) Or placebo was administered from 1 day after the end of each consolidation chemotherapy for 14 days. Results: The duration and incidence of febrile neutropenia was significantly r educed by 34% (P = .00285) and 17% (P = .02065), respectively, in 88 a ssessable patients in the M-CSF group compared with those in 94 assess able patients in the placebo group. patients in the M-CSF group had 56 5 days and 133 episodes of febrile neutropenia during 7,901 days at ri sk, while patients in the placebo group had 977 days and 185 episodes during 9,077 days at risk. The median period required to finish the th ree courses of consolidation therapy was 93 days in the M-CSF group, w hich was significantly shorter than 110 days in placebo group (P = .00 50). In the M-CSF group, the recovery of neutrophils and platelets was significantly faster (P = .0348 and P = 0.0364, respectively), the ad ministration of systemic antimicrobial agents tended to be less (P = . 0839), and the frequency of platelet transfusion (P = .0259) and the t otal volume of transfused platelets (P = .0292) were significantly les s. However, there was no significant difference in the disease-free su rvival. Conclusion: M-CSF significantly reduced the incidence and dura tion of febrile neutropenia during the intensive consolidation therapy , and shortened the rime to complete consolidation chemotherapy in AML . (C) 1997 by American Society of Clinical Oncology.