A single-blind, randomised, vehicle-controlled dose-finding study of recombinant human granulocyte colony-stimulating factor (Lenograstim) in patients undergoing chemotherapy for solid cancers and lymphoma

Abstract This study evaluated the effect of glycosylated recombinant human granulocyte colony-stimulating factor (rHuGCSF; lenograstim) on neutrophil granulocyte counts and on cells of other haematopoietic lineages in 66 patients with solid cancer or lymphoma who received myelosuppressive chemotherapy. Beginning 1 day after completion of chemotherapy, patients received lenograstim (at dosages of 0.5, 2, 5 or 10 μ/kg) or vehicle subcutaneously once daily for 14 consecutive days. Compared with vehicle, lenograstim significantly accelerated neutrophil recovery after chemotherapy in a dose-dependent manner. Mean neutrophil counts recovered to > 1.0 × 10 9 cells/l by day 13 in the vehicle group compared with days 11, 10, 8 and 7 in the 0.5, 2, 5 and 10 μg/kg lenograstim groups, respectively. Doses of 0.5 and 2 μg/kg of lenograstim had a significant effect on the duration of neutropenia ( 9 cells/l), the area under the absolute neutrophil count (ANC) curve and the time to ANC nadir. The dose of 5 μg/kg additionally decreased the total area of neutropenia and gave the narrowest range of values for all neutrophil parameters, while the 10 μg/kg dose brought no added benefit. A dose-response effect of lenograstim on time to neutrophil recovery was observed both for patients who received chemotherapy on a single day ( n = 35) and for those who received chemotherapy over several days ( n = 29). Based on these findings, a dose of 5 μg/kg/day was chosen for further trials.