title: A prospective evaluation of the activity of human granulocyte-colony stimulating factor on the prevention of chemotherapy-related neutropenia in patients with advanced carcinoma.
abstract: After informed consent, 86 patients with advanced cancer undergoing potentially myelosuppressive cytotoxic chemotherapy were randomized to receive placebo or subcutaneous granulocyte-colony stimulating factor (G-CSF) 5 micrograms/Kg/day in order to prevent severe neutropenia and its related morbidity. The incidence of neutropenia (absolute neutrophil count < 1,000/mm3) was significantly reduced in patients receiving G-CSF than in controls (18% versus 42%; P < 0.05). The duration of neutropenia was also shortened by the administration of G-CSF (4.8 versus 8.2 days; P < 0.05). Therapy with G-CSF has also a positive impact on the dose-intensity of employed regimens. Patients treated with G-CSF showed oral fungal disease in 9% of cases, while control patients had a 21% incidence (NS). Patients treated with G-CSF received 91% of the programmed dose-intensity as compared to 71% of control patients (P < 0.05). These data strengthen the clinical usefulness of G-CSF in the prevention of chemotherapy-related neutropenia, infections, and reduction in dose-intensity. Further studies are required to establish if the increase in dose-intensity allowed by G-CSF treatment may positively influence the outcome of cancer patients.
authors.affiliation: Service of Chemotherapy, University of Palermo, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: A
authors.initials: A
authors.lastname: Testa
authors.forename: R
authors.initials: R
authors.lastname: Valenza
authors.forename: N
authors.initials: N
authors.lastname: Borsellino
authors.forename: C
authors.initials: C
authors.lastname: Cipolla
authors.forename: G
authors.initials: G
authors.lastname: Cannata
authors.forename: G
authors.initials: G
authors.lastname: Curto
authors.forename: M
authors.initials: M
authors.lastname: Latteri
authors.forename: M
authors.initials: M
authors.lastname: Florena
authors.forename: N
authors.initials: N
authors.lastname: Gebbia
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D005334:Fever / Q000150:complications; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor