A RANDOMIZED CONTROLLED-STUDY OF GRANULOCYTE-COLONY-STIMULATING FACTOR AFTER INTENSIVE INDUCTION AND CONSOLIDATION THERAPY IN PATIENTS WITHACUTE LYMPHOBLASTIC-LEUKEMIA

To determine the efficacy and optimal daily dose of recombinant human granulocyte colony-stimulating factor (rG-CSF) after intensive chemoth erapy, a prospective randomized study was conducted with daily intrave nous administration of 2, 5 or 10 mug/kg G-CSF after induction therapy , and 0, 2, 5 or 10 mug/kg after consolidation therapy, until neutroph il counts recovered to more than 2000/mm3. The subjects were 41 adult patients with newly diagnosed acute lymphoblastic leukemia (ALL). Afte r the induction therapy, neutrophil recovery to more than 1000/mm3 was significantly faster in the 5 (P = 0.047) and 10 mug/kg groups (P = 0 .011) than in the 2 mug/kg group, but did not differ between the 2 for mer groups. The median days of neutrophil recovery to more than 1000/m m3 were 8.5, 9 and 12 days, respectively. After the consolidation ther apy, neutrophil recovery to more than 1000/mm3 was significantly faste r in the 2, 5 and 10 mug/kg groups than in the no rG-CSF group (P < 0. 001, respectively), but did not differ among the 3 former groups. The median days of neutrophil recovery to more than 1000/mm3 were 12, 11, 10, and 23 days, respectively. Febrile neutropenia and incidence of do cumented infection tended to be less in the 5 and 10 mug/kg groups tha n in 0 and 2 mug/kg groups. A dose of 5 mug/kg rG-CSF given by a 30 mi n infusion daily seems to be an effective and optimal daily dose to ac celerate neutrophil recovery after intensive remission induction and c onsolidation chemotherapy in adults with acute lymphoblastic leukemia (ALL).