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 (rh G-CSF) at the following dose levels: 1 microgram, 5 micrograms, 10 micrograms, 20 micrograms and 40 micrograms/kg/day 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 in one patient at 10 micrograms/kg/day. The neutrophils were shown to be functionally normal in tests of their mobility and bactericidal activity. During the Phase II part of the patients were treated using a combination of i.v. Adriamycin, Ifosfamide and Etoposide. The chemotherapy was repeated every 3 weeks. rh G-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. Ten severe infective episodes were observed during the 20 cycles of chemotherapy which did not include rh G-CSF, while only one infective episode occurred in 20 courses when treated with rh G-CSF. These results demonstrate the utility of rh G-CSF in restoring functional neutrophils to patients undergoing intensive chemotherapy.
authors: Cancer Research Campaign Department of Medical Oncology, Christie Hospital, Manchester, U.K.
authors: M
authors: M
authors: Bronchud
authors: J H
authors: JH
authors: Scarffe
authors: N
authors: N
authors: Thatcher
authors: D
authors: D
authors: Crowther
authors: L M
authors: LM
authors: Souza
authors: N K
authors: NK
authors: Alton
authors: N G
authors: NG
authors: Testa
authors: T M
authors: TM
authors: Dexter
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D003115:Colony-Stimulating Factors / Q000627:therapeutic use / Q000633:toxicity*; D004317:Doxorubicin / Q000008:administration & dosage; D004341:Drug Evaluation; D005047:Etoposide / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007958:Leukocyte Count / Q000187:drug effects; D008175:Lung Neoplasms / Q000188:drug therapy*; D015080:Mesna / Q000008:administration & dosage; D009504:Neutrophils / Q000166:cytology / Q000187:drug effects; D010976:Platelet Count / Q000187:drug effects; D011994:Recombinant Proteins / Q000627:therapeutic use / Q000633:toxicity
chemical_list: D003115:Colony-Stimulating Factors; D006454:Hemoglobins; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D004317:Doxorubicin; D015080:Mesna; D007069:Ifosfamide