Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer

Br J Cancer. 1987 Dec;56(6):809-13. doi: 10.1038/bjc.1987.295.

Abstract

Twelve patients with advanced small cell carcinoma of the bronchus were treated by continuous infusion of recombinant human granulocyte colony-stimulating factor (rhG-CSF) at the following dose levels: 1 microgram, 5 micrograms, 10 micrograms, 20 micrograms and 40 micrograms kg-1 day-1 for 5 days. No toxicities resulted from the treatment and in all 12 patients the number of peripheral neutrophils increased rapidly to a maximum of 100 x 10(9) l-1 at 10 micrograms kg-1 day-1. The neutrophils were shown to be functionally normal in tests of their mobility and bactericidal activity. During the phase II part of the study the patients were treated by a combination of intravenous adriamycin 50 mg m-2, ifosfamide 5 g m-2 by i.v. infusion with mesna 8 g m-2 on day 1, and etoposide 120 mg m-2 on days 1, 2 and 3 also intravenously. The chemotherapy regime was repeated every 3 weeks. RhG-CSF was given to each patient for 14 days on alternate cycles of chemotherapy and reduced the period of absolute neutropenia considerably (median of 80%), with a return to normal, or above normal, neutrophil counts within 2 weeks after day 1 of chemotherapy. Six severe infective episodes were observed during the cycles of chemotherapy which did not include rhG-CSF, while no infective episodes occurred when patients were treated with rhG-CSF. These results demonstrate the utility of rhG-CSF in restoring functional neutrophils to patients undergoing intensive chemotherapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Agranulocytosis / prevention & control*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bronchial Neoplasms / complications
  • Bronchial Neoplasms / drug therapy*
  • Carcinoma, Small Cell / complications
  • Carcinoma, Small Cell / drug therapy*
  • Colony-Stimulating Factors / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Evaluation
  • Female
  • Granulocytes
  • Humans
  • Male
  • Neutropenia / prevention & control*

Substances

  • Colony-Stimulating Factors