The optimal dose of glycosylated recombinant human granulocyte colony stimulating factor for use in clinical practice: a review.

In pharmacokinetic studies, higher maximum plasma concentrations of granulocyte colony stimulating factor (G-CSF) were achieved after intravenous administration of lenograstim than after subcutaneous administration of the same dose. However, subcutaneous administration resulted in a longer elimination half life, and a greater and more sustained neutrophil response. The safety of lenograstim at doses up to 40 micrograms/kg/day has been demonstrated in Phase I studies involving 21 healthy volunteers and 37 cancer patients. In controlled Phase II dose-ranging studies which included 66 solid tumour and 121 bone marrow transplantation (BMT) patients, doses from 2 micrograms/kg/day were shown to effectively restore neutrophil counts. A dose of 5 micrograms/kg/day was chosen for further clinical trials. Phase III double-blind randomised studies in a further 439 patients with solid tumours or postBMT confirmed the clinical efficacy of the recommended therapeutic dose of lenograstim of 150 micrograms/m2/day which is equivalent in efficacy to 5 micrograms/kg/day. At this unique dose, one 263-microgram vial of lenograstim is sufficient to effectively treat the average adult patient in solid tumour or bone marrow transplantation settings.