A randomized controlled trial of filgrastim during remission induction and consolidation chemotherapy for adults with acute lymphoblastic leukemia: CALGB study 9111.

摘要: Recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim) shortens the time to neutrophil recovery after intensive chemotherapy, but its role in treatment of adults with acute lymphoblastic leukemia (ALL) is uncertain. We randomly assigned 198 untreated ALL (median age, 35 years; range, 16 83) receive either placebo or G-CSF (5 microgram/kg/d) subcutaneously, beginning 4 days starting remission induction chemotherapy and continuing until count was >/=1, 000/microL for 2 days. The study assignment unblinded as individual patients achieved a complete (CR). Patients initially then continued through monthly courses consolidation therapy. received no further drug. median recover neutrophils >/=1,000/microL during course (interquartile range [IQR], 15 18 days) 22 (IQR, 19 29 (P /=1,000/microL than did control group by approximately 6 9 However, not planned first 3 months any more rapidly group. Overall toxicity lessened use G-CSF. After follow-up 4. 7 years, there were significant differences disease-free survival = .53) overall .25) (medians, 2.3 years 2.4 respectively) compared those 1.7 1.8 respectively). Adults who benefited from treatment, markedly affect ultimate outcome.