A randomized controlled study of granulocyte colony stimulating factor after intensive induction and consolidation therapy in patients with acute lymphoblastic leukemia. Japan Adult Leukemia Study Group.

To determine the efficacy and optimal daily dose of recombinant human granulocyte colony-stimulating factor (rG-CSF) after intensive chemotherapy, a prospective randomized study was conducted with daily intravenous administration of 2, 5 or 10 micrograms/kg G-CSF after induction therapy, and 0, 2, 5 or 10 micrograms/kg after consolidation therapy, until neutrophil counts recovered to more than 2000/mm3. The subjects were 41 adult patients with newly diagnosed acute lymphoblastic leukemia (ALL). After the induction therapy, neutrophil recovery to more than 1000/mm3 was significantly faster in the 5 (P = 0.047) and 10 micrograms/kg groups (P = 0.011) than in the 2 micrograms/kg group, but did not differ between the 2 former groups. The median days of neutrophil recovery to more than 1000/mm3 were 8.5, 9 and 12 days, respectively. After the consolidation therapy, neutrophil recovery to more than 1000/mm3 was significantly faster in the 2, 5 and 10 micrograms/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 documented infection tended to be less in the 5 and 10 micrograms/kg groups than in 0 and 2 micrograms/kg groups. A dose of 5 micrograms/kg rG-CSF given by a 30 min infusion daily seems to be an effective and optimal daily dose to accelerate neutrophil recovery after intensive remission induction and consolidation chemotherapy in adults with acute lymphoblastic leukemia (ALL).