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

Eur J Cancer. 1995 Dec;31A(13-14):2157-63. doi: 10.1016/0959-8049(95)00197-2.

Abstract

This study evaluated the effect of glycosylated recombinant human granulocyte colony-stimulating factor (rHuG-CSF; 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 micrograms/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 x 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 micrograms/kg lenograstim groups, respectively. Doses of 0.5 and 2 micrograms/kg of lenograstim had a significant effect on the duration of neutropenia (< 1.0 x 10(9) cells/l), the area under the absolute neutrophil count (ANC) curve and the time to ANC nadir. The dose of 5 micrograms/kg additionally decreased the total area of neutropenia and gave the narrowest range of values for all neutrophil parameters, while the 10 micrograms/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 micrograms/kg/day was chosen for further trials.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adult
  • Aged
  • Antibiotics, Antineoplastic / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Drug Therapy, Combination
  • Epirubicin / therapeutic use
  • Female
  • 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 / drug therapy*
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Single-Blind Method

Substances

  • Adjuvants, Immunologic
  • Antibiotics, Antineoplastic
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Lenograstim