title: Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer.
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.
authors.affiliation: Department of Medical Oncology, Paterson Institute for Cancer Research, Christie Hospital and Holt Radium Institute, Manchester, UK.
authors.forename: M H
authors.initials: MH
authors.lastname: Bronchud
authors.forename: J H
authors.initials: JH
authors.lastname: Scarffe
authors.forename: N
authors.initials: N
authors.lastname: Thatcher
authors.forename: D
authors.initials: D
authors.lastname: Crowther
authors.forename: L M
authors.initials: LM
authors.lastname: Souza
authors.forename: N K
authors.initials: NK
authors.lastname: Alton
authors.forename: N G
authors.initials: NG
authors.lastname: Testa
authors.forename: T M
authors.initials: TM
authors.lastname: Dexter
mesh_terms: D000368:Aged; D000380:Agranulocytosis / Q000517:prevention & control*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001984:Bronchial Neoplasms / Q000150:complications / Q000188:drug therapy*; D018288:Carcinoma, Small Cell / Q000150:complications / Q000188:drug therapy*; D003115:Colony-Stimulating Factors / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006098:Granulocytes; D006801:Humans; D008297:Male; D009503:Neutropenia / Q000517:prevention & control*
chemical_list: D003115:Colony-Stimulating Factors