title: Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer: an overview of safety considerations from the Research on Adverse Drug Events and Reports project.
abstract: Granulocyte-colony stimulating factor (G-CSF) is widely administered to donors who provide peripheral blood stem cells (PBSC) for individuals who undergo hematopoietic stem cell transplants. Questions have been raised about the safety of G-CSF in this setting. Herein, the Research on Adverse Drug Events and Reports (RADAR) project investigators reviewed the literature on G-CSF-associated adverse events in healthy individuals or persons with chronic neutropenia or cancer. Toxicities identified included bone pain and rare instances of splenic rupture, allergic reactions, flares of underlying autoimmune disorders, lung injury and vascular events. Among healthy individuals, four patients developed splenic rupture shortly after G-CSF administration and three patients developed acute myeloid leukemia 1 to 5 years after G-CSF administration. Registry studies identified no increased risks of malignancy among healthy individuals who received G-CSF before PBSC harvesting. However, more than 2000 donors would have to be followed for 10 years to detect a 10-fold increase in leukemia risk. Our review identifies bone pain as the most common toxicity of G-CSF administration. There are questions about a causal relationship between G-CSF administration and acute leukemia, but more long-term safety data from database registries are needed to adequately evaluate such a relationship.
authors.affiliation: Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
authors.forename: C C
authors.initials: CC
authors.lastname: Tigue
authors.forename: J M
authors.initials: JM
authors.lastname: McKoy
authors.forename: A M
authors.initials: AM
authors.lastname: Evens
authors.forename: S M
authors.initials: SM
authors.lastname: Trifilio
authors.forename: M S
authors.initials: MS
authors.lastname: Tallman
authors.forename: C L
authors.initials: CL
authors.lastname: Bennett
mesh_terms: D001842:Bone and Bones; D002908:Chronic Disease; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects*; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D015470:Leukemia, Myeloid, Acute / Q000139:chemically induced; D008171:Lung Diseases / Q000139:chemically induced; D055370:Lung Injury; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D009503:Neutropenia / Q000150:complications* / Q000188:drug therapy; D010146:Pain / Q000139:chemically induced; D012042:Registries; D012307:Risk Factors; D013161:Splenic Rupture / Q000139:chemically induced; D013997:Time Factors; D014184:Transplantation, Homologous; D014652:Vascular Diseases / Q000139:chemically induced
chemical_list: D016179:Granulocyte Colony-Stimulating Factor