title: Subcutaneous versus intravenous granulocyte colony stimulating factor for the treatment of neutropenia in hospitalized hemato-oncological patients: randomized controlled trial.
abstract: Intravenous (IV) granulocyte colony stimulating factor (G-CSF) might be safer and more convenient than subcutaneous (SC) administration to hospitalized hemato-oncological patients receiving chemotherapy. To compare IV vs. SC G-CSF administration, we conducted a randomized, open-label trial. We included inpatients receiving chemotherapy for acute myeloid leukemia, acute lymphoblastic leukemia, lymphoma or multiple myeloma, and allogeneic or autologous hematopoietic cell transplantation (HCT). Patients were randomized to 5 mcg/kg single daily dose of IV bolus versus SC filgrastim given for its clinical indications. Patients were crossed-over to the alternate study arm on the subsequent chemotherapy course. The primary outcomes were time from initiation of filgrastim to recovery of stable neutrophil count of >500 cells/µL and a composite clinical outcome of infection or death assessed for the first course post-randomization. The study was stopped on the second interim analysis. Of 120 patients randomized, 118 were evaluated in the first treatment course. The mean time to neutropenia resolution was longer with IV G-CSF [7.9 days, 95% confidence interval (CI) 6.6-9.1] compared with SC G-CSF (5.4 days, 95% CI 4.6-6.2), log-rank P = 0.001. Longer neutropenia duration was observed in all patient subgroups, except for patients undergoing autologous HCT. There was no significant difference between groups in the occurrence of infection or death, but more deaths were observed with IV (4/57, 7%) versus SC (1/61, 1.6%) G-CSF administration, P = 0.196. Similar results were observed when all 158 courses following cross-over were analyzed. Patients reported similar pain and satisfaction scores in both groups. Bolus IV administration of G-CSF results in longer neutropenia duration than SC administration, with no difference in clinical or quality-of-life measures.
authors.affiliation: Unit of Infectious Diseases, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Israel.
authors.forename: Mical
authors.initials: M
authors.lastname: Paul
authors.forename: Ron
authors.initials: R
authors.lastname: Ram
authors.forename: Eitan
authors.initials: E
authors.lastname: Kugler
authors.forename: Laura
authors.initials: L
authors.lastname: Farbman
authors.forename: Anat
authors.initials: A
authors.lastname: Peck
authors.forename: Leonard
authors.initials: L
authors.lastname: Leibovici
authors.forename: Meir
authors.initials: M
authors.lastname: Lahav
authors.forename: Moshe
authors.initials: M
authors.lastname: Yeshurun
authors.forename: Ofer
authors.initials: O
authors.lastname: Shpilberg
authors.forename: Corina
authors.initials: C
authors.lastname: Herscovici
authors.forename: Ofir
authors.initials: O
authors.lastname: Wolach
authors.forename: Gilad
authors.initials: G
authors.lastname: Itchaki
authors.forename: Michal
authors.initials: M
authors.lastname: Bar-Natan
authors.forename: Liat
authors.initials: L
authors.lastname: Vidal
authors.forename: Anat
authors.initials: A
authors.lastname: Gafter-Gvili
authors.forename: Pia
authors.initials: P
authors.lastname: Raanani
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000627:therapeutic use; D019337:Hematologic Neoplasms / Q000150:complications / Q000188:drug therapy; D018380:Hematopoietic Stem Cell Transplantation; D017052:Hospital Mortality; D006801:Humans; D007239:Infections / Q000209:etiology; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007297:Inpatients; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy* / Q000209:etiology; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000188:drug therapy / Q000209:etiology; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim