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

• Published in: European journal of cancer (1990) Vol. 31; no. 13; pp. 2157 - 2163
• Main Authors: Seymour, A.-M., de Campos, E., Thatcher, N., De Greve, J., Cunningham, D., Howell, A., Tueni, E., Bron, D.G., Steward, W.P., Berdel, W.E., Knuth, A., Lorenz, J., Timothy, A.R., Yver, A., Richards, M.A.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.1995
• Subjects: Adjuvants, Immunologic - administration & dosage; Adult; Aged; Antibiotics, Antineoplastic - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; chemotherapy; Drug Therapy, Combination; Epirubicin - therapeutic use; Female; granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Humans; Lenograstim; Leukocyte Count; Lymphoma - drug therapy; Male; Middle Aged; Neoplasms - drug therapy; neutropenia; Neutropenia - drug therapy; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; rHuG-CSF; Single-Blind Method; solid cancer; neutropenia; rHuG-CSF; granulocyte colony-stimulating factor; chemotherapy; solid cancer; lenograstim
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/0959-8049(95)00197-2

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 (< 1.0 × 10 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.