Efficacy of a new formulation of lenograstim (recombinant glycosylated human granulocyte colony-stimulating factor) containing gelatin for the treatment of neutropenia after consolidation chemotherapy in patients with acute myeloid leukemia

The efficacy and safety of a new formulation of lenograstim (recombinant gl ycosylated granulocyte colony-stimulating factor) prepared by switching the stabilizer from human serum albumin (HSA) to gelatin was investigated for the treatment of neutropenia after consolidation chemotherapy in patients w ith acute myeloid leukemia (AML). The results obtained in the study using t he gelatin-containing formulation (gelatin-lenograstim) were retrospectivel y compared to those obtained from a placebo-controlled double-blind randomi zed study (AML-DBT) using the HSA-containing formulation (HSA-lenograstim). The median time of neutrophil recovery to greater than or equal to 1000/mm (3) was significantly shorter in the gelatin-lenograstim group (14 days) th an in the placebo group (21 days, P = .0001), and there was no significant difference between the gelatin-lenograstim group and the HSA-lenograstim gr oup (14.5 days of AML-DBT, P = .5462). The incidences of febrile neutropeni a were significantly reduced in the gelatin-lenograstim group (24/43, 55.8% ) compared to the placebo group (58/64, 90.6%, P < .0001). The incidence of fever and antibiotic use was also significantly lower in the gelatin-lenog rastim group (69.5% and 83.7%,respectively) than in the placebo group (92.2 %, P = .0034, and 96.9%, P = .0285, respectively). However, between the 2 g roups there were no differences in the number of patients who had infectiou s episodes No serious adverse drug reactions ascribed to gelatin-lenograsti m were encountered. These results demonstrate that gelatin-lenograstim exer ted beneficial effects in the acceleration of neutrophil recovery and in th e reduction of fever, febrile neutropenia, and antibiotic use, and its effi cacy was equivalent to HSA-lenograstim. Therefore, we concluded that the ge latin-lenograstim formulation, which offers no risk of virus contamination and can be stored at room temperature, is more beneficial than the HSA-leno grastim formulation. (C) 2000 The Japanese Society of Hematology.