Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy

Eur J Cancer. 1993;29A(3):319-24. doi: 10.1016/0959-8049(93)90376-q.

Abstract

The aim of this study was to determine the usefulness of recombinant human granulocyte colony stimulating factor (r-metHuG-CSF) following conventional chemotherapy for small cell lung cancer. 130 previously untreated patients were randomised to receive either r-metHuG-CSF (230 micrograms/m2) or placebo on days 4-17 following CDE (cyclophosphamide, doxorubicin and etoposide) chemotherapy. Over all cycles, 53% of 64 patients on placebo and only 26% of 65 patients on r-metHuG-CSF had at least one experience of neutropenia with fever defined as a neutrophil count less than 1.0 x 10(9)/l and a temperature > or = 38.2 degrees C (P < 0.002). It resulted in a reduction in the requirement for parenteral antibiotics from 58% in placebo patients compared with 37% in the r-metHuG-CSF group (P < 0.02), and a significant reduction in the incidence of infection-related hospitalisation. Chemotherapy doses were reduced by 15% or more at least once in 61% of the placebo group compared with 29% in the r-metHuG-CSF group (P < 0.001). 47% of the patients treated with placebo and 29% of the patients treated with r-metHuG-CSF experienced at least one cycle with a delay of 2 days or more in the administration of chemotherapy (P < 0.04). r-metHuG-CSF was well tolerated. There were no significant differences between the two groups in terms of response or survival.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Bacterial Infections / prevention & control
  • Carcinoma, Small Cell / therapy*
  • Cyclophosphamide / administration & dosage
  • Double-Blind Method
  • Doxorubicin / administration & dosage
  • Etoposide / administration & dosage
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Lung Neoplasms / therapy*
  • Male
  • Middle Aged
  • Neutropenia / prevention & control*
  • Recombinant Proteins / therapeutic use

Substances

  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Etoposide
  • Doxorubicin
  • Cyclophosphamide